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Rectal analgesia for pain from perineal trauma following

childbirth (Review)
Hedayati H, Parsons J, Crowther CA

This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library
2009, Issue 1
http://www.thecochranelibrary.com

Rectal analgesia for pain from perineal trauma following childbirth (Review)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
AUTHORS CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ACKNOWLEDGEMENTS
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.1. Comparison 1 Rectal suppository versus placebo, Outcome 1 Any pain experienced <= 24 hours after birth.
Analysis 1.2. Comparison 1 Rectal suppository versus placebo, Outcome 2 Any pain experienced 24 to < 72 hours after
birth. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.3. Comparison 1 Rectal suppository versus placebo, Outcome 3 Pain experienced <= 24 hours after birth.
Analysis 1.4. Comparison 1 Rectal suppository versus placebo, Outcome 4 Pain experienced 24 to < 72 hours after birth.
Analysis 1.9. Comparison 1 Rectal suppository versus placebo, Outcome 9 Use of additional analgesia for perineal pain 12
hours after birth. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.10. Comparison 1 Rectal suppository versus placebo, Outcome 10 Use of additional analgesia for perineal pain
24 hours after birth. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.11. Comparison 1 Rectal suppository versus placebo, Outcome 11 Use of additional analgesia for perineal pain
48 hours after birth. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.12. Comparison 1 Rectal suppository versus placebo, Outcome 12 Use of additional analgesia for perineal pain
72 hours after birth. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
WHATS NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
INDEX TERMS
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Rectal analgesia for pain from perineal trauma following childbirth (Review)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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[Intervention Review]

Rectal analgesia for pain from perineal trauma following


childbirth
Hedyeh Hedayati1 , Jacqueline Parsons1 , Caroline A Crowther2
1 Department of Public Health, The University of Adelaide, Adelaide, Australia. 2 School of Paediatrics and Reproductive Health,
Discipline of Obstetrics and Gynaecology, The University of Adelaide, Adelaide, Australia

Contact address: Jacqueline Parsons, Department of Public Health, The University of Adelaide, Level 6, Bice Building, Royal Adelaide
Hospital, Adelaide, South Australia, 5005, Australia. jacqueline.parsons@adelaide.edu.au.
Editorial group: Cochrane Pregnancy and Childbirth Group.
Publication status and date: Edited (no change to conclusions), published in Issue 1, 2009.
Review content assessed as up-to-date: 31 March 2003.
Citation: Hedayati H, Parsons J, Crowther CA. Rectal analgesia for pain from perineal trauma following childbirth. Cochrane Database
of Systematic Reviews 2003, Issue 3. Art. No.: CD003931. DOI: 10.1002/14651858.CD003931.
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

ABSTRACT
Background
Perineal pain from a tear and/or surgical cut (episiotomy) is a common problem following vaginal birth. Strategies to reduce perineal
trauma and the appropriate repair of any perineal damage sustained are important for avoiding and alleviating pain. Where pain is
present, numerous treatments are used in clinical practice, such as local anaesthetics, oral analgesics, therapeutic ultrasound, antiseptics
and non-pharmacological applications such as ice packs and baths. This review assesses the evidence for using rectal analgesia for pain
relief following perineal trauma.
Objectives
To assess the effectiveness of analgesic rectal suppositories for pain from perineal trauma following childbirth.
Search methods
We searched the Cochrane Pregnancy and Childbirth Group trials register (July 2002), CENTRAL (The Cochrane Library, Issue 2,
2002), CINAHL (May 2002) and MIDIRS (May 2002).
Selection criteria
Randomised controlled trials comparing analgesic rectal suppositories with placebo or alternative treatment for the relief of perineal
pain.
Data collection and analysis
Two reviewers assessed trial quality and extracted data independently.
Main results
Three trials involving 249 women met the inclusion criteria. Only two of the trials identified for inclusion in this review had data that
could be entered in a meta-analysis, with the third not providing data in a useable format. Women were less likely to experience pain at
or close to 24 hours after birth if they received non-steroidal anti-inflammatory drugs (NSAID) suppositories compared with placebo
(relative risk (RR) 0.37, 95% confidence interval (CI) 0.10 to 1.38, 2 trials, 150 women). Women in the NSAID suppositories group
compared with women in the placebo group required less additional analgesia in the first 24 hours after birth (RR 0.31, 95% CI 0.17
Rectal analgesia for pain from perineal trauma following childbirth (Review)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

to 0.54, 1 trial, 89 women) and this effect was still evident at 48 hours postpartum (RR 0.63, 95% CI 0.45 to 0.89, 1 trial, 89 women).
No information was available on pain experienced more than 72 hours after birth or other outcomes of importance to women such as
the impact on daily activities, resumption of sexual intercourse and the impact on the mother-baby relationship.
Authors conclusions
NSAID rectal suppositories are associated with less pain up to 24 hours after birth, and less additional analgesia is required. More
research is required regarding long-term effects and maternal satisfaction with the treatment.

PLAIN LANGUAGE SUMMARY


Rectal analgesia for pain from perineal trauma following childbirth
Rectal suppositories give short-term pain relief for perineal trauma after childbirth.
Women often suffer pain if their birth involves trauma to the perineum (area between the vagina and the anus). This trauma can result
from an episiotomy (surgical cut) or from a tear that requires stitching. There are ways to reduce the possibility of trauma, but for
women with pain the review of trials found that rectal suppositories were effective for pain relief up to 24 hours after birth. Longerterm effects have not been investigated. More research is required to assess the longer-term outcomes and effects, if any, on breast milk,
mother-baby bonding and sexual functioning.

BACKGROUND
Perineal pain from a tear and/or surgical cut (episiotomy) is a common problem following vaginal birth. In resource-rich countries at
least 65% of women undergoing vaginal birth experience perineal
pain (Albers 1999) and scarce data from under-resourced countries suggest that 35 to 45% of women who give birth in a hospital experience an episiotomy (Maduma-Butshe 1998). Not only
does perineal pain negatively impact on the physical and mental
functioning of the woman, but it may decrease the success for the
mother to breastfeed, reduce her ability to care for her new baby
(Sleep 1991) and may impair the establishment of a good quality
mother-baby interaction. Physical factors associated with perineal
pain such as reduced mobility, urinary and faecal incontinence,
perineal discomfort whilst sitting and sexual dysfunction can lead
to mental exhaustion and may be detrimental to the experiences
of motherhood.
Perineal pain is reported to be most severe in the immediate postnatal period; however, discomfort continues for up to two weeks
postpartum in 20 to 25% of women (Sleep 1984; Albers 1999).
For up to 10% of women, pain continues for at least three months
(Sleep 1984; Glazener 1995).
Avoiding damage to the perineum and appropriate repair of perineal damage are the best primary methods for pain avoidance
and alleviation. Practices for avoiding damage to the perineum
include massage and guarding the perineum with the birth attendants hands during contractions (Enkin 2002). Two Cochrane

reviews (Kettle 2002a; Kettle 2002b) have examined the effectiveness of different repair methods and materials. However, pain
relief is important where pain is present (Sleep 1989). Numerous treatments are common in clinical practice including topical
anaesthetics, oral analgesics, therapeutic ultrasound, local antiseptics, simple and narcotic analgesics and non-pharmacological applications in the form of sprays, gels, creams, ice packs and baths
(Sleep 1989). Evaluation of some of these treatments has suggested
a positive treatment effect and further research has been recommended (Sleep 1989). Some of these treatments are the subject
of existing Cochrane reviews or new reviews, for example Therapeutic ultrasound for postpartum perineal pain and dyspareunia
(Hay-Smith 2002) and Localised cooling treatment for perineal
wounds following childbirth (Steen 2002). The protocol for Topically applied local anaesthetic for the treatment of perineal pain
after childbirth has been published (Hedayati 2003).
Where perineal pain is mild, paracetamol is the most common
analgesic used (Sleep 1989). As pain increases to moderate and
severe levels, a variety of drugs have been used but very few of
these are free of side effects (Sleep 1989). This includes the use
of opioid, non-opioid and a combination of both opioid and
non-opioid analgesics. Opioid analgesics such as morphine and
codeine act centrally on the nervous system (Jacobson 1987)
and are more widely used for severe pain where other measures
are not responsive (MIMS 2000). Non-opioid analgesics include

Rectal analgesia for pain from perineal trauma following childbirth (Review)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

the non-steroidal anti-inflammatory drugs (NSAIDs) such as indomethacin, ibuprofen and diclofenac, which are widely used for
their analgesic and anti-pyretic properties. Prostaglandins play a
major role in pain, and NSAIDs work as potent prostaglandin synthetase inhibitors. This inhibition sensitises afferent nerves, which
may lower prostaglandins in peripheral tissues and in turn reduce
pain (MIMS 2000). Unfortunately, NSAIDs are not free of risk
and areas of concern include gastric irritation, haematological effects and renal failure (Pavy 1995; RCA 1998).
An important issue associated with postpartum analgesic use is
the potential passage into breast milk. Some analgesics such as acetaminophen, ibuprofen, and codeine are usually compatible with
breastfeeding but drugs such as aspirin have been linked to significant effects on the infant such as metabolic acidosis and hence are
contraindicated (AAP 1994). However, dosage is important, with
minimal use of certain analgesics (once or twice daily) understood
to result in only low levels of drug circulation and passage into
breast milk (Windle 1989).
In general medical care, the rectal route of analgesic administration may be used when oral therapy is inappropriate (Nissen 1992)
such as when oral preparations cause gastric upset (Sleep 1989),
nausea and vomiting (Insel 1990), or when the patient is unconscious (Insel 1990). Patient attitudes towards the route of administration are also very important. A survey of this has shown that
although patients choose oral over rectal treatment, if the rectal
route is more appropriate, patients prefer to be informed and give
verbal consent prior to administration (Vyvyan 1995). Rectal administration is advantageous in that about 50% of the drug absorbed by the rectum will bypass the liver and therefore not be
metabolised, compared with a higher proportion of hepatic firstpass metabolism with oral ingestion (Gilman 1990). This suggests
that the rectal route may result in faster pain relief and be more
effective upon local action. Studies assessing the efficacy of rectal
analgesia for other types of pain such as post-operative pain have
shown rectal analgesia to significantly reduce pain levels (Nissen
1992) and in some reports there has been less usage of additional
analgesia (Sims 1994; Scott 1997). This suggests that rectal analgesia may be effective for perineal pain.
The aim of this review is to systematically evaluate available evidence from randomised controlled trials that investigate pain relief, maternal satisfaction and costs of using rectal analgesia for
relief from perineal pain following childbirth.

OBJECTIVES
To assess the effectiveness of analgesic rectal suppositories
for relief of perineal pain following childbirth.
To assess the need for additional analgesia when analgesic
rectal suppositories are used.

To compare the cost of analgesic rectal suppositories with


other types of analgesia for perineal pain.
To assess womens satisfaction with treatment and its effects
on emotional well-being and quality of life.

METHODS

Criteria for considering studies for this review

Types of studies
All identified randomised controlled trials comparing analgesic
rectal suppositories with placebo or alternative treatment for the
relief of perineal pain were considered for inclusion in the review.

Types of participants
Women who have had a perineal tear or an episiotomy during
vaginal birth that required perineal suturing.

Types of interventions
Randomised controlled trials comparing any type of rectal analgesia for perineal pain with:
(a) rectal placebo;
(b) oral, intravenous or intramuscular analgesic therapy;
(c) any other treatment modalities for pain relief from perineal
trauma;
(d) no treatment.

Types of outcome measures


(1) Pain, however measured by the authors, at the following time
periods (or as close to the latter time period as possible):
(a) up to 24 hours after birth;
(b) between 24 hours and 72 hours after birth;
(c) between 3 days and 14 days after birth;
(d) between 14 days and 6 weeks after birth.
(2) Pain associated with activities of daily living (including sitting,
walking, caring for baby, urinating), however measured by the
authors, at the following time periods (or as close to the latter time
period as possible):
(a) up to 24 hours after birth;
(b) between 24 hours and 72 hours after birth;
(c) between 3 days and 14 days after birth;
(d) between 14 days and 6 weeks after birth.
(3) Failure to have pain-free sexual intercourse at 3 months postpartum.
(4) Additional analgesia for perineal pain:

Rectal analgesia for pain from perineal trauma following childbirth (Review)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

(a) need for type and timing of additional analgesia in hospital;


(b) need for and type of additional analgesia after discharge from
hospital.
(5) Side effects severe enough to discontinue treatment.
(6) Cost of the treatment.
(7) Number of women breastfeeding at:
(a) discharge from hospital;
(b) 6 weeks postpartum.
(8) Adverse effects on mother-baby interactions, however measured (e.g. ability to provide good quality care).
(9) Maternal satisfaction with treatment.
(10) Length of hospital stay.
(11) The effects on maternal quality of life, however measured.
(12) Number of women with postnatal depression, however measured.

Search methods for identification of studies

Electronic searches
We searched the Cochrane Pregnancy and Childbirth Group trials
register (July 2002).
The Cochrane Pregnancy and Childbirth Groups trials register is
maintained by the Trials Search Co-ordinator and contains trials
identified from:
1. quarterly searches of the Cochrane Central Register of
Controlled Trials (CENTRAL);
2. monthly searches of MEDLINE;
3. handsearches of 30 journals and the proceedings of major
conferences;
4. weekly current awareness search of a further 37 journals.
Details of the search strategies for CENTRAL and MEDLINE,
the list of handsearched journals and conference proceedings, and
the list of journals reviewed via the current awareness service can be
found in the Search strategies for identification of studies section
within the editorial information about the Cochrane Pregnancy
and Childbirth Group.
Trials identified through the searching activities described above
are given a code (or codes) depending on the topic. The codes are
linked to review topics. The Trials Search Co-ordinator searches
the register for each review using these codes rather than keywords.
In addition, we searched CENTRAL (The Cochrane Library, Issue 2, 2002), CINAHL (May 2002) and MIDIRS (May 2002)
databases. When necessary, researchers were contacted to provide
further information. No language restrictions were placed.
We used the following search terms: (perine* pain or perine*
trauma or genital tract trauma or episiotomy) and ((analgesi* and
rectal*) or suppository). We used MeSH where available in combination with free-text terms.
Reference lists of trials and other review articles were searched.

Data collection and analysis


All studies identified by the search strategy outlined above were
considered for inclusion. Trials included were evaluated for appropriateness and methodological quality without consideration
of their results. Two reviewers independently assessed trials for inclusion. Any differences of opinion were resolved by discussion.
Reasons for excluding trials were recorded and reported in the review.
The methodological quality of the included studies was assessed
using the criteria described in Section six of the Cochrane Handbook (Clarke 2002). Quality scores for allocation concealment
were assigned to each trial, where A = adequate, B = unclear, C =
clearly inadequate. Studies rated as a C were eliminated.
Studies were assessed for completeness of follow up:
(a) fewer than 3% of participants excluded;
(b) 3% to 9.9% of participants excluded;
(c) 10% to 19.9% of participants excluded;
(d) 20% or more excluded;
(e) unclear.
Studies rated as a D were eliminated.
Where appropriate, studies were also assessed for blinding:
(a) Double blind: neither investigator nor participant knew or
were likely to guess the allocated treatment.
(b) Single blind: either the investigator or the participant knew
the allocation, or side effects of one or other treatment mean that
it is likely that the allocation could be correctly identified in a
significant proportion (more than 20%) of participants.
(c) No blinding: both investigator and participant knew or were
likely to guess the allocated treatment.
(d) Unclear.
Studies that were not blinded due to the nature of the interventions
were included in the review.
Studies were not excluded on the use of a placebo due to the nature
of the possible comparisons (i.e. alternative treatment rather than
placebo).
Where feasible, the following subgroup analyses were planned to
be undertaken:
(a) type of rectal analgesia used;
(b) spontaneous vaginal birth versus operative vaginal birth;
(c) episiotomy compared with perineal tear;
(d) primiparous women compared with multiparous women.
None of these subgroup analyses were undertaken due to the limited data available from the trials.
Two reviewers independently extracted and double entered data.
There was no blinding of authorship. Whenever necessary, unpublished data were sought from investigators. Statistical analyses were
performed using the Review Manager software (RevMan 2000).
Included trial data were processed as described in the Cochrane
Handbook (Clarke 2002).
Categorical data were compared using relative risks and 95% confidence intervals using a fixed effects model. Statistical heterogene-

Rectal analgesia for pain from perineal trauma following childbirth (Review)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

ity between trials was assessed using the chi square test and, where
present, a random effects model was used.
All eligible trials were included in the initial analysis and sensitivity
analyses carried out to evaluate the effect of trial quality. This was
done by excluding trials given a B rating for quality for allocation
concealment, then E and C for completeness of follow up, then C
and D for blinding (where appropriate).

RESULTS

Description of studies
See: Characteristics of included studies; Characteristics of excluded
studies.
See table of Characteristics of Included Studies.
Two of the three included trials compared diclofenac with placebo
(Yoong 1997; Searles 1998) and the third study compared indomethacin with placebo for pain from perineal trauma (Odigie
1988).
The three included trials were all single centred, with two of them
located in the United Kingdom (UK) (Yoong 1997; Searles 1998)
and the third in Saudi Arabia (Odigie 1988). Both of the UK
studies looked at diclofenac suppositories compared with placebo
whilst the third trial investigated indomethacin in comparison
with placebo.
All trials administered 100 mg suppositories. One trial administered a single dose (Yoong 1997) while the other two trials (Odigie
1988; Searles 1998) administered two suppositories (total 200 mg
suppositories). The Odigie trial (Odigie 1988) administered both
suppositories (200 mgs) after suturing whereas the other (Searles
1998) gave one immediately after suturing and the second 12
hours after the first suppository.
All three studies included women who had an episiotomy, and
one trial also included women with a second-degree tear (Searles
1998) .
Primary outcomes in the two more recent studies (Yoong 1997;
Searles 1998) were pain after birth, measured at 24 and 48 hours
in the Yoong study (Yoong 1997) and at 12, 24, 48 and 72 hours
in the Searles study (Searles 1998). The earlier trial (Odigie 1988)
focussed on pain 15 to 90 minutes after birth. In all studies, the
women themselves, using a variety of measures including numerical scales and visual analogue scales, assessed pain.

Risk of bias in included studies


Searles (Searles 1998) explicitly reported the methods of randomisation and the concealment of treatment allocation was judged
to be adequate. Random number tables using a block containing
equal proportions of odd and even numbers were used to code

the suppositories where the last digit was coded for either the diclofenac or placebo suppositories. The method of randomisation
was unclear in the other two trials (Odigie 1988; Yoong 1997).
Yoong (Yoong 1997) performed random allocation after birth by
drawing a coded sealed envelope. No further information was
given so it was unclear as to the randomisation method and how
well treatment allocation was concealed. Odigie 1988 reported
that there was random allocation to the two groups. They provided no further information regarding concealment of treatment
allocation. Clarification has been sought from the authors.
The studies were all placebo-controlled. The placebo was not specified in each trial but in all studies they were said to be identical
in colour and similarly shaped.
All trials stated that they were double-blinded. However, only Searles (Searles 1998) explicitly reported how blinding was achieved.
In this trial the pharmacy department supplied the treatment packs
and the participant and the outcome assessor were blinded. The
pharmacy prepared identical foil wrapped packages that were further placed in a sealed container and identified by a number 1 to
100. Yoong 1997 and Odigie 1988 made no mention of who was
blinded or how it was achieved.
Odigie 1988 reported no losses to follow up. In Searles (Searles
1998) 11 out of 100 (11%) were lost to follow up, and 10 out of
120 (8%) in Yoong 1997 were lost to follow up.

Effects of interventions
Three trials that involved 249 women met the inclusion criteria
(Odigie 1988; Yoong 1997; Searles 1998). Two studies were excluded from the review; one as it included two other types of postnatal pain as well as perineal pain (Ray 1993); and one as it had a
loss to follow up more than 20% (Van der Pas 1984).
Only two of the trials identified for inclusion in this review had
data that could be entered in meta-analysis (Odigie 1988; Searles
1998). The third did not provide data in a useable format (Yoong
1997). The authors of this study have been contacted in an attempt
to acquire further data. Most of the outcomes pre-specified in this
review were not measured in the trials. Only eight pre-specified
outcomes were measured in the included studies.

Presence of pain
Any pain experienced up to 24 hours after birth:
Pain was measured at 90 minutes in the Odigie 1988 trial and at
24 hours in the Searles 1998 trial. A random effects model was
used here as statistical heterogeneity was present between the studies. However, this model produced a summary measure with less
precision than the individual studies. The random effects model
resulted in very wide confidence intervals that crossed one around
the summary estimate (relative risk (RR) 0.37, 95% confidence
intervals (CI) 0.10 to 1.38, 2 trials, 150 women), despite the in-

Rectal analgesia for pain from perineal trauma following childbirth (Review)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

dividual studies both having relative risks favouring the treatment


group.

Mild, moderate and severe pain after 72 hours after birth

Pain was not measured between 3 days and 14 days after birth or
between 14 days and 6 weeks after birth in any of the included
studies.

The severity of pain was not measured between 3 days and 14 days
after birth or between 14 days and 6 weeks after birth in any of
the trials.
The Yoong 1997 study measured pain using pain scores and visual
analogue scales (VAS) in 110 women. The data were reported
as medians and thus could not be included in the meta-analysis.
According to the pain scores of the study, women experienced less
pain in the NSAID suppositories group at 24 hours (diclofenac:
median 1, range 0 to 2.5; placebo: median 1, range 0 to 3; p <
0.05 using Mann-Whitney U test) but no statistically significant
difference was seen after the time period between 24 hours and
72 hours after birth (diclofenac: median 1, range 0 to 3; placebo:
median 1, range 0 to 4, p value not reported).
The effect on pain-free sexual intercourse at 3 months postpartum
was not measured in any of the trials.

Severity of pain

Additional analgesia use

Any pain experienced between 24 hours and 72 hours


after birth
There was no difference found for pain between 24 and 72 hours
after birth in the one trial that measured this outcome (Searles
1998); (RR 0.73, 95% CI 0.53 to 1.02, one trial, 99 women).

Pain experienced more than 72 hours after birth

Two trials (Yoong 1997; Searles 1998) reported on the severity


of pain (mild, moderate and severe) at different times after birth.
Heterogeneity was found with one category in this analysis, thus
a random effects model was used for all three categories.

Mild pain experienced up to 24 hours after birth

There was no difference between the treatment groups for mild


pain less than or equal to 24 hours after administration (RR 1.12,
95% CI 0.70 to 1.80, 2 trials,149 women).

Moderate pain up to 24 hours after birth

Women receiving non-steroidal anti-inflammatory drug (NSAID)


suppositories compared with placebo had less moderate pain 24
hours after birth compared with placebo (RR 0.13, 95% CI 0.02
to 0.76, 2 trials, 149 women).

Severe pain up to 24 hours after birth

There was no difference between the treatment groups for severe


pain (RR 0.21, 95% CI 0.01 to 4.12, 2 trials, 149 women).

Need for, type and timing of additional analgesia in hospital

Only one of the included trials, with 89 women (Searles 1998)


presented appropriate data for inclusion in the meta-analysis regarding additional analgesia use for perineal pain up to 72 hours
postpartum. Women in the NSAID suppositories group required
less additional analgesia up to 24 hours (RR 0.31, 95% CI 0.17
to 0.54, 1 trial, 89 women) and this effect was still evident at 48
hours postpartum (RR 0.63, 95% CI 0.45 to 0.89, 1 trial, 89
women). No difference was seen for additional analgesia use for
perineal pain 72 hours postpartum.
The Yoong 1997 study provided data on use of additional analgesia but not in a format suitable to include in the meta-analysis.
They reported on the amount of extra paracetamol (in grams) used
by the 110 women in the study, and found women in the NSAID
suppositories group used less paracetamol in the first 24 hours after birth and this was maintained up to 48 hours after birth (diclofenac; mean 0.6g, standard deviation (sd) 0.53, placebo mean
1.11g, sd 0.57, P < 0.05, compared using two-sample t-test). The
need for, type and timing of additional analgesia were not measured beyond 48 hours.

Side effects of treatment


Severity of pain experienced between 24 hours and 72 hours
after birth

Only Searles 1998 reported severity of pain experienced between


24 hours and 72 hours after birth and found no difference in
the NSAID suppositories group in comparison with the placebo
group for the three severity groups.

All three trials reported that there were no side effects experienced
by women using the analgesic rectal suppositories or with placebo.
Longer-term outcomes such as the number of women breastfeeding at discharge from hospital and 6 weeks postpartum, effects on
mother-baby interactions, maternal satisfaction with treatment,
length of hospital stay, effects on maternal quality of life and number of women with postnatal depression were not measured by

Rectal analgesia for pain from perineal trauma following childbirth (Review)
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any of the authors. No comparison of costs of analgesic rectal suppositories with other types of analgesia for perineal pain were presented in any of the trials.

DISCUSSION
The methodological quality of the studies varied. Treatment allocation was only adequate in the Searles 1998 trial and unclear in
the other trials (Odigie 1988; Yoong 1997). There were no losses
to follow up in the Odigie 1988 study, but a loss to follow up
exceeded 10% for Searles 1998 and was 8% for Yoong 1997. All
the studies were placebo-controlled.
Given these limitations, rectal analgesia appears effective for reducing moderate pain from perineal trauma following childbirth
in the short term (within 24 hours) and results in less additional
analgesia use compared with placebo up to 48 hours after birth.
No side effects with the use of the rectal analgesia have been reported in these trials. Side effects did not appear to be a pre-specified study outcome in any of the trials since the lack of side effects
were only mentioned in the discussion.
Although there was statistical heterogeneity between the studies for
some of the primary outcomes, independently the studies favoured
rectal analgesia. This heterogeneity is possibly explained by the
different time points used for pain measurement in the studies.
No information is available on pain experienced more than 3 days
after birth. Similarly no information is reported on other outcomes important to women such as the impact on daily activities,
resumption of sexual intercourse and the impact on the motherbaby relationship.
Acceptability of the rectal route of administration is an important
issue and if postpartum women are not comfortable with taking
pain relief in the form of a suppository, the effectiveness of the
drug becomes irrelevant. This outcome was not addressed in any
of the three trials included in this review.

AUTHORS CONCLUSIONS
Implications for practice
This review shows that rectal analgesia can reduce pain from perineal trauma following childbirth experienced by women and the
intensity of any pain within the first 24 hours after birth. Women
use less additional analgesia within the first 48 hours after birth
when analgesic rectal suppositories are used. The effect, if any, on
longer-term pain relief and analgesia use is not known.

Implications for research


Further research should assess the duration of the pain relief experienced and the effects of different timing of treatments, different
dosages, different lengths of treatment and comparison of the different analgesic drugs available as suppositories or other modalities, as well as the impact these regimens have on the passage of
the drug into breast milk.
The limited controlled evaluations on the long-term impact of
rectal analgesia for perineal pain suggests that further research is
necessary. More research is required to assess impact on activities
of daily living, longer-term pain, resumption of sexual intercourse
and mother-baby relationships. Adequate allocation concealment,
follow up and the measurement of relevant outcomes should be
key components of any future randomised controlled trials.

ACKNOWLEDGEMENTS
Jacqueline Parsons was funded by a grant from the Commonwealth
Department of Health and Ageing to support Australian reviewers
in the Cochrane Pregnancy and Childbirth Collaborative Review
Group.

REFERENCES

References to studies included in this review


Odigie 1988 {published data only}
Odigie E. Effectiveness of indocid (indomethacin)
suppositories as post-episiotomy analgesia. Saudi Medical
Journal 1987;8(3):2748.

Odigie E. Effectiveness of indomethacin (indocid)


suppositories as post-episiotomy analgesia. International
Journal of Gynecology & Obstetrics 1988;26:5760.
Searles 1998 {published data only}

Searles J, Pring D. Effective analgesia following perineal


injury during childbirth: a placebo controlled trial of

prophylactic rectal diclofenac. British Journal of Obstetrics


and Gynaecology 1998;105:62731.
Searles J, Pring D. Improving perineal pain relief. 27th
British Congress of Obstetrics and Gynaecology; 1995 July
4-7; Dublin, Ireland, 1995:499.
Yoong 1997 {published data only}
Yoong W, Biervliet F, Nagrani R. The prophylactic use of
diclofenac (voltarol) suppositories in perineal pain after
episiotomy. A random allocation double-blind study.
Journal of Obstetrics and Gynaecology 1997;17(1):3941.

References to studies excluded from this review

Rectal analgesia for pain from perineal trauma following childbirth (Review)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Ray 1993 {published data only}


Ray S, Swami A, Kadim M, Morgan B. Efficacy of
diclofenac in a single prophylactic dose in post partum pain.
International Journal of Obstetric Anesthesia 1993;2:58.
Van der Pas 1984 {published data only}
Van der Pas, HFM, Vertommen F. A double-blind study of
naproxen suppositories for post-episiotomy pain compared
with asa, oxyfenbutazon and placebo [Dubbelblind studie
met naproxeensuppositoria bij pijn na episiotomie, in
vergelijking met ASA, oxyfenbutazon en placebo]. Ars
Medici Revue Internationale de Therapie Pratique 1984;39
(5):7981.

Additional references
AAP 1994
American Academy of Pediatrics Committee on Drugs. The
transfer of drugs and other chemicals into human milk.
Pediatrics 1994;93(1):13750.
Albers 1999
Albers L, Garcia J, Renfrew M, McCandlish R, Elbourne
D. Distribution of genital tract trauma in childbirth and
related postnatal pain. Birth 1999;26:115.
Clarke 2002
Clarke M, Oxman AD, editors. Cochrane Reviewers
Handbook 4.1.5 [updated April 2002]. In: The Cochrane
Library, Issue 2, 2002. Oxford: Update Software. Updated
quarterly.
Enkin 2002
Enkin M, Keirse M, Neilson J, Crowther C, Duley L,
Hodnett E, et al.A guide to effective care in pregnancy and
childbirth. 3rd Edition. Oxford: Oxford University Press,
2000.
Gilman 1990
Gilman G. Drug absorption, bioavailability, and routes
of administration. In: Gilman G editor(s). The
pharmacological basis of therapeutics. 8th Edition. New York:
Macmillan Publishing Co., 1990:7.
Glazener 1995
Glazener C, Abdalla M, Stroud P, Naji S, Templeton A,
Russell I. Postnatal maternal morbidity: extent, causes,
prevention and treatment. British Journal of Obstetrics and
Gynaecology 1995;102:2827.
Hay-Smith 2002
Hay-Smith JC. Therapeutic ultrasound for postpartum
perineal pain and dyspareunia (Cochrane Review). The
Cochrane Library 2002, Issue 2.[Art. No.: CD000495.
DOI: 10.1002/14651858.CD000495]

G editor(s). The pharmacological basis of therapeutics. 8th


Edition. New York: Macmillan Publishing Co., 1990:
61724.
Jacobson 1987
Jacobson J, Bertilson SO. Analgesic efficacy of paracetamol/
codeine and paracetamol/dextropropoxyphene. Journal of
International Medical Research 1987;15(2):8995.
Kettle 2002a
Kettle C, Johanson RB. Absorpable synthetic vs catgut
suture material for perineal repair (Cochrane Review). The
Cochrane Library 2002, Issue 3.
Kettle 2002b
Kettle C, Johanson RB. Continuous vs interrupted sutures
for perineal repair (Cochrane Review). The Cochrane
Library 2002, Issue 3.
Maduma-Butshe 1998
Maduma-Butshe A, Dyall A, Garner P. Routine episiotomy
in developing countries. BMJ 1998;316:117980.
MIMS 2000
MIMS Australia. 2000 MIMS Annual. St.Leonards, NSW,
Australia: MediMedia Australia Pty Limited, 2000.
Nissen 1992
Nissen I, Jensen KA, Ohrstrom JK. Indomethacin in the
management of post-operative pain. British Journal of
Anaesthesia 1992;69(3):3046.
Pavy 1995
Pavy T, Gambling D, Merrick P, Douglas M. Rectal
indomethacin potentiates spinal morphine analgesia after
caesarean delivery. Anaesthesia and Intensive Care 1995;23
(5):5559.
RCA 1998
RCA 98. Guidelines for the use of NSAID in perioperative
period. Clinical Guidelines. Oxford: Hall the Printer Ltd,
1998.
RevMan 2000
The Cochrane Collaboration. Review Manager [RevMan].
4.1 for Windows. Oxford, England: The Cochrane
Collaboration, 2000.
Scott 1997
Scott RM, Jennings PN. Rectal diclofenac analgesia after
abdominal hysterectomy. Australian and New Zealand
Journal of Obstetrics and Gynaecology 1997;37(1):1124.
Sims 1994
Sims C, Johnson CM, Bergesio R, Delfos SJ, Avraamides
EA. Rectal indomethacin for analgesia after appendicectomy
in children. Anaesthesia and Intensive Care 1994;22(3):
2725.

Hedayati 2003
Hedayati H, Parsons J, Crowther C. Topically applied
anaesthetics for treatment of perineal pain after childbirth
(Protocol for a Cochrane Review). The Cochrane Library
2003, Issue 2.

Sleep 1984
Sleep J, Grant A, Garcia J, Elbourne D, Spencer J, Chalmers
I. West Berkshire perineal management trial. BMJ 1984;
289:58790.

Insel 1990
Insel P. Analgesic-antipyretic and anti-inflammatory agents
and drugs employed in the treatment of gout. In: Gilman

Sleep 1989
Grant A, Sleep J. Relief of perineal pain and discomfort
after childbirth. In: Chalmers I, Enkin M, Keirse MJNC

Rectal analgesia for pain from perineal trauma following childbirth (Review)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

editor(s). Effective care in pregnancy and childbirth. Vol. 2,


Oxford: Oxford University Press, 1989:134858.
Sleep 1991
Sleep J. Perineal care: a series of five randomised trials. In:
Robinson S, Thomson AM editor(s). Midwives, Research
and Childbirth. Vol. 2, London: Chapman and Hall, 1991:
199251.
Steen 2002
Steen M, Marchant P, Briggs M. Localised cooling treatment
for perineal wounds (Protocol for a Cochrane Review). The

Cochrane Library 2002, Issue 2.


Vyvyan 1995
Vyvyan H, Hanafiah Z. Patients attitudes to rectal drug
administration. Anaesthesia 1995;50:9834.
Windle 1989
Windle ML, Booker LA, Rayburn WF. Postpartum pain
after vaginal delivery. A review of comparative analgesic
trials. Journal of Reproductive Medicine 1989;34(11):8915.

Indicates the major publication for the study

Rectal analgesia for pain from perineal trauma following childbirth (Review)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

CHARACTERISTICS OF STUDIES

Characteristics of included studies [ordered by study ID]


Odigie 1988
Methods

Single centre, Saudi Arabia. Random allocation to 2 groups (indomethacin or placebo) on admission method not described.
Not convinced that double-blind although stated as such.
No information available regarding concealment of treatment allocation.
All participants included in the trial were included in the analysis

Participants

60 women (treatment = 30, placebo = 30) aged between 15-42 years with routine episiotomy. Parity
- primigravida and multigravida: numbers similar in each group. Women would be co-operative, from
similar environmental situation (Middle East) and similar body weight

Interventions

Treatment = 2 x 100 mg indomethacin suppositories. Placebo suppositories. Placebo is identical colour.


Suppositories inserted within 15 min of perineal repair.
Pain was evaluated by the author himself.

Outcomes

Pain 15, 30, 60 and 90 min after suppositories inserted, assessed by women.
Performed twice at each assessment point using a numerical scale

Notes

Using drugs that might influence results.

Risk of bias
Item

Authors judgement

Description

Allocation concealment?

Unclear

B - Unclear

Searles 1998
Methods

Single centre: York.


A random number table used to code the suppositories using a block containing odd and even numbers
in equal proportions. The last digit coded for either active drug or placebo and the suppositories were
issued in sealed containers numbered 1-100. Codes available 24 hours a day but not broken during trial.
Outcome assessment was double blind.
No intention to treat analysis.
No information available regarding concealment of treatment allocation

Participants

100 women randomised, 89 analysed (treatment = 45, placebo = 44) having a spontaneous vaginal delivery
at term with either an episiotomy or a second degree tear were enrolled in study.
Mean age - 25.3 yrs in placebo group and 25.2 yrs in diclofenac group

Interventions

One 100 mg diclofenac or placebo suppository inserted at the end of suturing and the second administered
12 hours later by midwifery staff. Identical placebo suppositories

Rectal analgesia for pain from perineal trauma following childbirth (Review)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

10

Searles 1998

(Continued)

Outcomes

Women rated pain at 12, 24, 48 and 72 hours using a six point numerical system.
Use of additional analgesia at 12, 24, 48 and 72 hours.
Significant incidence of side effects was measured but not reported. Same applies to the method of analgesia
being acceptable to women

Notes

Operative vaginal deliveries, first degree tears and labial grazes were excluded. Also excluded were those
with a history of peptic ulceration, inflammatory bowel disease, asthma or a history of aspirin allergy.
Women entered in trial were not offered other non-steroidal anti-inflammatory agents until at least 12
hours after the administration of the second suppository

Risk of bias
Item

Authors judgement

Description

Allocation concealment?

Yes

A - Adequate

Yoong 1997
Methods

Single centre: Birmingham UK.


Following delivery, random allocation by drawing a coded sealed envelope containing either a 100 mg
diclofenac suppository or a similarly shaped placebo.
No information available regarding concealment of treatment allocation. No intention to treat analysis

Participants

120 women randomised, 110 women analysed with uncomplicated medio-lateral episiotomies to aid
normal vaginal delivery without epidural analgesia (treatment = 56, placebo = 54).
All repaired with same technique and suture material.

Interventions

Treatment = 1 x 100 mg diclofenac suppositories.


Placebo suppositories.
Suppositories inserted during rectal examination that followed episiotomy repair.
Placebo was similarly shaped.

Outcomes

Pain analysed at 24 and 48 hours by women using a visual analogue scale and additional paracetamol
recorded.
Side effects, and patient acceptability were also measured but not reported

Notes

Women excluded were those with extension of episiotomy or significant labial or vaginal lacerations.
Those with asthma, porphyria, salicylate hypersensitivity, peptic ulceration and significant cardiac, renal
or hepatic disease. Finally those requesting a 6-hour discharge. Authors were contacted to provide results
in a useable format but no response was received

Risk of bias
Item

Authors judgement

Description

Allocation concealment?

Unclear

B - Unclear

Rectal analgesia for pain from perineal trauma following childbirth (Review)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

11

min: minutes
yrs: years

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Ray 1993

Study was for three types of post partum pain - uterine cramps and oedema as well as episiotomy - and the results
could not be separated. The authors were contacted to get the appropriate results but no response was received

Van der Pas 1984

Methodology was poor, with only 61/108 women included in follow up for primary outcome (pain). According to
pre-specified methodology, studies with more than 20% of participants lost to follow up are excluded. Moreover,
the study does not explain how pain was measured

Rectal analgesia for pain from perineal trauma following childbirth (Review)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

12

DATA AND ANALYSES

Comparison 1. Rectal suppository versus placebo

Outcome or subgroup title


1 Any pain experienced <= 24
hours after birth
2 Any pain experienced 24 to < 72
hours after birth
3 Pain experienced <= 24 hours
after birth
3.1 Mild pain
3.2 Moderate pain
3.3 Severe pain
4 Pain experienced 24 to < 72
hours after birth
4.1 Mild pain
4.2 Moderate pain
4.3 Severe pain
5 Pain experienced 3 to 14 days
after birth
6 Pain experienced 14 days to 6
weeks after birth
7 Pain associated with activities of
daily living
8 Failure to have pain-free sexual
intercourse at 3 months
postpartum
9 Use of additional analgesia for
perineal pain 12 hours after
birth
9.1 Diclofenac versus placebo
10 Use of additional analgesia for
perineal pain 24 hours after
birth
10.1 Diclofenac versus
placebo
11 Use of additional analgesia for
perineal pain 48 hours after
birth
11.1 Diclofenac versus
placebo
12 Use of additional analgesia for
perineal pain 72 hours after
birth
12.1 Diclofenac versus
placebo

No. of
studies

No. of
participants

150

Risk Ratio (M-H, Random, 95% CI)

0.39 [0.11, 1.31]

89

Risk Ratio (M-H, Fixed, 95% CI)

0.73 [0.53, 1.02]

Risk Ratio (M-H, Random, 95% CI)

Subtotals only

Statistical method

Effect size

2
2
2
1

149
149
149

Risk Ratio (M-H, Random, 95% CI)


Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Random, 95% CI)
Risk Ratio (M-H, Fixed, 95% CI)

1.12 [0.70, 1.80]


0.13 [0.02, 0.76]
0.21 [0.01, 4.12]
Subtotals only

1
1
1
0

89
89
89
0

Risk Ratio (M-H, Fixed, 95% CI)


Risk Ratio (M-H, Fixed, 95% CI)
Risk Ratio (M-H, Fixed, 95% CI)
Risk Ratio (M-H, Fixed, 95% CI)

0.98 [0.62, 1.55]


0.39 [0.13, 1.15]
0.20 [0.01, 3.96]
Not estimable

Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

89

Risk Ratio (M-H, Fixed, 95% CI)

0.20 [0.07, 0.53]

1
1

89
89

Risk Ratio (M-H, Fixed, 95% CI)


Risk Ratio (M-H, Fixed, 95% CI)

0.20 [0.07, 0.53]


0.31 [0.17, 0.54]

89

Risk Ratio (M-H, Fixed, 95% CI)

0.31 [0.17, 0.54]

89

Risk Ratio (M-H, Fixed, 95% CI)

0.63 [0.45, 0.89]

89

Risk Ratio (M-H, Fixed, 95% CI)

0.63 [0.45, 0.89]

89

Risk Ratio (M-H, Fixed, 95% CI)

0.52 [0.25, 1.10]

89

Risk Ratio (M-H, Fixed, 95% CI)

0.52 [0.25, 1.10]

Rectal analgesia for pain from perineal trauma following childbirth (Review)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

13

Analysis 1.1. Comparison 1 Rectal suppository versus placebo, Outcome 1 Any pain experienced <= 24
hours after birth.
Review:

Rectal analgesia for pain from perineal trauma following childbirth

Comparison: 1 Rectal suppository versus placebo


Outcome: 1 Any pain experienced <= 24 hours after birth

Study or subgroup

Treatment

Control

n/N

n/N

Odigie 1988

6/30

30/30

46.7 %

0.21 [ 0.11, 0.42 ]

Searles 1998

26/45

40/45

53.3 %

0.65 [ 0.50, 0.85 ]

75

75

100.0 %

0.39 [ 0.11, 1.31 ]

Total (95% CI)

Risk Ratio
MH,Random,95%
CI

Weight

Risk Ratio
MH,Random,95%
CI

Total events: 32 (Treatment), 70 (Control)


Heterogeneity: Tau2 = 0.71; Chi2 = 11.08, df = 1 (P = 0.00087); I2 =91%
Test for overall effect: Z = 1.53 (P = 0.13)

0.1 0.2

0.5

Favours treatment

10

Favours control

Rectal analgesia for pain from perineal trauma following childbirth (Review)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

14

Analysis 1.2. Comparison 1 Rectal suppository versus placebo, Outcome 2 Any pain experienced 24 to < 72
hours after birth.
Review:

Rectal analgesia for pain from perineal trauma following childbirth

Comparison: 1 Rectal suppository versus placebo


Outcome: 2 Any pain experienced 24 to < 72 hours after birth

Study or subgroup

Searles 1998

Total (95% CI)

Treatment

Control

n/N

n/N

Risk Ratio

Weight

24/45

32/44

100.0 %

0.73 [ 0.53, 1.02 ]

45

44

100.0 %

0.73 [ 0.53, 1.02 ]

M-H,Fixed,95% CI

Risk Ratio
M-H,Fixed,95% CI

Total events: 24 (Treatment), 32 (Control)


Heterogeneity: not applicable
Test for overall effect: Z = 1.85 (P = 0.064)

0.1 0.2

0.5

Favours treatment

10

Favours control

Rectal analgesia for pain from perineal trauma following childbirth (Review)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

15

Analysis 1.3. Comparison 1 Rectal suppository versus placebo, Outcome 3 Pain experienced <= 24 hours
after birth.
Review:

Rectal analgesia for pain from perineal trauma following childbirth

Comparison: 1 Rectal suppository versus placebo


Outcome: 3 Pain experienced <= 24 hours after birth

Study or subgroup

NSAID

Placebo

Risk Ratio
MH,Random,95%
CI

Weight

Risk Ratio
MH,Random,95%
CI

n/N

n/N

Odigie 1988

6/30

5/30

45.6 %

1.20 [ 0.41, 3.51 ]

Searles 1998

18/45

16/44

54.4 %

1.10 [ 0.65, 1.87 ]

75

74

100.0 %

1.12 [ 0.70, 1.80 ]

1 Mild pain

Subtotal (95% CI)


Total events: 24 (NSAID), 21 (Placebo)

Heterogeneity: Tau2 = 0.0; Chi2 = 0.02, df = 1 (P = 0.89); I2 =0.0%


Test for overall effect: Z = 0.46 (P = 0.64)
2 Moderate pain
Odigie 1988

0/30

14/30

30.5 %

0.03 [ 0.00, 0.55 ]

Searles 1998

4/45

18/44

69.5 %

0.22 [ 0.08, 0.59 ]

75

74

100.0 %

0.13 [ 0.02, 0.76 ]

Subtotal (95% CI)


Total events: 4 (NSAID), 32 (Placebo)

Heterogeneity: Tau2 = 0.88; Chi2 = 1.78, df = 1 (P = 0.18); I2 =44%


Test for overall effect: Z = 2.26 (P = 0.024)
3 Severe pain
Odigie 1988

0/30

11/30

32.1 %

0.04 [ 0.00, 0.71 ]

Searles 1998

4/45

6/44

67.9 %

0.65 [ 0.20, 2.15 ]

75

74

100.0 %

0.21 [ 0.01, 4.12 ]

Subtotal (95% CI)


Total events: 4 (NSAID), 17 (Placebo)

Heterogeneity: Tau2 = 3.51; Chi2 = 3.94, df = 1 (P = 0.05); I2 =75%


Test for overall effect: Z = 1.02 (P = 0.31)

0.1 0.2

0.5

Favours NSAID

10

Favours placebo

Rectal analgesia for pain from perineal trauma following childbirth (Review)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

16

Analysis 1.4. Comparison 1 Rectal suppository versus placebo, Outcome 4 Pain experienced 24 to < 72
hours after birth.
Review:

Rectal analgesia for pain from perineal trauma following childbirth

Comparison: 1 Rectal suppository versus placebo


Outcome: 4 Pain experienced 24 to < 72 hours after birth

Study or subgroup

NSAID

Placebo

n/N

n/N

Risk Ratio

Weight

20/45

20/44

100.0 %

0.98 [ 0.62, 1.55 ]

45

44

100.0 %

0.98 [ 0.62, 1.55 ]

4/45

10/44

100.0 %

0.39 [ 0.13, 1.15 ]

45

44

100.0 %

0.39 [ 0.13, 1.15 ]

0/45

2/44

100.0 %

0.20 [ 0.01, 3.96 ]

45

44

100.0 %

0.20 [ 0.01, 3.96 ]

M-H,Fixed,95% CI

Risk Ratio
M-H,Fixed,95% CI

1 Mild pain
Searles 1998

Subtotal (95% CI)


Total events: 20 (NSAID), 20 (Placebo)
Heterogeneity: not applicable

Test for overall effect: Z = 0.10 (P = 0.92)


2 Moderate pain
Searles 1998

Subtotal (95% CI)


Total events: 4 (NSAID), 10 (Placebo)
Heterogeneity: not applicable

Test for overall effect: Z = 1.70 (P = 0.089)


3 Severe pain
Searles 1998

Subtotal (95% CI)


Total events: 0 (NSAID), 2 (Placebo)
Heterogeneity: not applicable

Test for overall effect: Z = 1.06 (P = 0.29)

0.1 0.2

0.5

Favours NSAID

10

Favours placebo

Rectal analgesia for pain from perineal trauma following childbirth (Review)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

17

Analysis 1.9. Comparison 1 Rectal suppository versus placebo, Outcome 9 Use of additional analgesia for
perineal pain 12 hours after birth.
Review:

Rectal analgesia for pain from perineal trauma following childbirth

Comparison: 1 Rectal suppository versus placebo


Outcome: 9 Use of additional analgesia for perineal pain 12 hours after birth

Study or subgroup

Treatment

Control

n/N

n/N

Risk Ratio

Weight

Searles 1998

4/45

20/44

100.0 %

0.20 [ 0.07, 0.53 ]

Total (95% CI)

45

44

100.0 %

0.20 [ 0.07, 0.53 ]

M-H,Fixed,95% CI

Risk Ratio
M-H,Fixed,95% CI

1 Diclofenac versus placebo

Total events: 4 (Treatment), 20 (Control)


Heterogeneity: not applicable
Test for overall effect: Z = 3.23 (P = 0.0012)

0.1 0.2

0.5

Favours treatment

10

Favours control

Analysis 1.10. Comparison 1 Rectal suppository versus placebo, Outcome 10 Use of additional analgesia for
perineal pain 24 hours after birth.
Review:

Rectal analgesia for pain from perineal trauma following childbirth

Comparison: 1 Rectal suppository versus placebo


Outcome: 10 Use of additional analgesia for perineal pain 24 hours after birth

Study or subgroup

NSAID

Placebo

n/N

n/N

Risk Ratio

Weight

10/45

32/44

100.0 %

0.31 [ 0.17, 0.54 ]

45

44

100.0 %

0.31 [ 0.17, 0.54 ]

M-H,Fixed,95% CI

Risk Ratio
M-H,Fixed,95% CI

1 Diclofenac versus placebo


Searles 1998

Total (95% CI)

Total events: 10 (NSAID), 32 (Placebo)


Heterogeneity: not applicable
Test for overall effect: Z = 4.04 (P = 0.000054)

0.1 0.2

0.5

Favours NSAID

10

Favours placebo

Rectal analgesia for pain from perineal trauma following childbirth (Review)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

18

Analysis 1.11. Comparison 1 Rectal suppository versus placebo, Outcome 11 Use of additional analgesia for
perineal pain 48 hours after birth.
Review:

Rectal analgesia for pain from perineal trauma following childbirth

Comparison: 1 Rectal suppository versus placebo


Outcome: 11 Use of additional analgesia for perineal pain 48 hours after birth

Study or subgroup

NSAID

Placebo

n/N

n/N

Risk Ratio

Weight

22/45

34/44

100.0 %

0.63 [ 0.45, 0.89 ]

45

44

100.0 %

0.63 [ 0.45, 0.89 ]

M-H,Fixed,95% CI

Risk Ratio
M-H,Fixed,95% CI

1 Diclofenac versus placebo


Searles 1998

Total (95% CI)

Total events: 22 (NSAID), 34 (Placebo)


Heterogeneity: not applicable
Test for overall effect: Z = 2.65 (P = 0.0081)

0.1 0.2

0.5

Favours NSAID

10

Favours placebo

Analysis 1.12. Comparison 1 Rectal suppository versus placebo, Outcome 12 Use of additional analgesia for
perineal pain 72 hours after birth.
Review:

Rectal analgesia for pain from perineal trauma following childbirth

Comparison: 1 Rectal suppository versus placebo


Outcome: 12 Use of additional analgesia for perineal pain 72 hours after birth

Study or subgroup

NSAID

Placebo

n/N

n/N

Risk Ratio

Weight

Searles 1998

8/45

15/44

100.0 %

0.52 [ 0.25, 1.10 ]

Total (95% CI)

45

44

100.0 %

0.52 [ 0.25, 1.10 ]

M-H,Fixed,95% CI

Risk Ratio
M-H,Fixed,95% CI

1 Diclofenac versus placebo

Total events: 8 (NSAID), 15 (Placebo)


Heterogeneity: not applicable
Test for overall effect: Z = 1.70 (P = 0.089)

0.1 0.2

0.5

Favours NSAID

10

Favours placebo

Rectal analgesia for pain from perineal trauma following childbirth (Review)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

19

WHATS NEW
Last assessed as up-to-date: 31 March 2003.

Date

Event

Description

20 September 2008

Amended

Converted to new review format.

HISTORY
Protocol first published: Issue 3, 2002
Review first published: Issue 3, 2003

CONTRIBUTIONS OF AUTHORS
All reviewers contributed to the protocol. Hedyeh Hedayati and Jacqueline Parsons extracted the data, and wrote the text of the review.
Caroline Crowther commented on each draft of the review.

DECLARATIONS OF INTEREST
None known.

SOURCES OF SUPPORT
Internal sources
Department of Obstetrics and Gynaecology, University of Adelaide, Australia.

External sources
Commonwealth Department of Health and Ageing, Australia.

INDEX TERMS
Medical Subject Headings (MeSH)
Administration, Rectal; Analgesia, Obstetrical [ methods]; Analgesics [administration & dosage]; Anti-Inflammatory Agents, NonSteroidal [ administration & dosage]; Episiotomy [adverse effects]; Obstetric Labor Complications [ drug therapy]; Pain [ drug
therapy]; Parturition; Perineum [ injuries]

Rectal analgesia for pain from perineal trauma following childbirth (Review)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

20

MeSH check words


Female; Humans; Pregnancy

Rectal analgesia for pain from perineal trauma following childbirth (Review)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

21

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