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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
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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]
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.
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.
METHODS
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.
Rectal analgesia for pain from perineal trauma following childbirth (Review)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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.
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.
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.
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
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)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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.
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
Rectal analgesia for pain from perineal trauma following childbirth (Review)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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]
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.
Rectal analgesia for pain from perineal trauma following childbirth (Review)
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CHARACTERISTICS OF STUDIES
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
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
Risk of bias
Item
Authors judgement
Description
Allocation concealment?
Unclear
B - Unclear
Searles 1998
Methods
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)
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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
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
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)
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11
min: minutes
yrs: years
Study
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
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
No. of
studies
No. of
participants
150
89
Subtotals only
Statistical method
Effect size
2
2
2
1
149
149
149
1
1
1
0
89
89
89
0
Not estimable
Not estimable
Not estimable
89
1
1
89
89
89
89
89
89
89
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:
Study or subgroup
Treatment
Control
n/N
n/N
Odigie 1988
6/30
30/30
46.7 %
Searles 1998
26/45
40/45
53.3 %
75
75
100.0 %
Risk Ratio
MH,Random,95%
CI
Weight
Risk Ratio
MH,Random,95%
CI
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:
Study or subgroup
Searles 1998
Treatment
Control
n/N
n/N
Risk Ratio
Weight
24/45
32/44
100.0 %
45
44
100.0 %
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
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:
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 %
Searles 1998
18/45
16/44
54.4 %
75
74
100.0 %
1 Mild pain
0/30
14/30
30.5 %
Searles 1998
4/45
18/44
69.5 %
75
74
100.0 %
0/30
11/30
32.1 %
Searles 1998
4/45
6/44
67.9 %
75
74
100.0 %
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:
Study or subgroup
NSAID
Placebo
n/N
n/N
Risk Ratio
Weight
20/45
20/44
100.0 %
45
44
100.0 %
4/45
10/44
100.0 %
45
44
100.0 %
0/45
2/44
100.0 %
45
44
100.0 %
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
1 Mild pain
Searles 1998
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:
Study or subgroup
Treatment
Control
n/N
n/N
Risk Ratio
Weight
Searles 1998
4/45
20/44
100.0 %
45
44
100.0 %
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
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:
Study or subgroup
NSAID
Placebo
n/N
n/N
Risk Ratio
Weight
10/45
32/44
100.0 %
45
44
100.0 %
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
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:
Study or subgroup
NSAID
Placebo
n/N
n/N
Risk Ratio
Weight
22/45
34/44
100.0 %
45
44
100.0 %
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
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:
Study or subgroup
NSAID
Placebo
n/N
n/N
Risk Ratio
Weight
Searles 1998
8/45
15/44
100.0 %
45
44
100.0 %
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
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
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
Rectal analgesia for pain from perineal trauma following childbirth (Review)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
21