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Lee S. Simon, MD
Division Director
Analgesic, Anti-inflammatory and
Ophthalmology Drug Products
ODEV, CDER, FDA
PAIN
Pain is always a subjective experience
Everyone learns the meaning of pain
through experiences usually related to
injuries in early life
As an unpleasant sensation it becomes an
emotional experience
Pain is a significant stress physically,
emotionally
Pain
In one hundred years there has been clear
progress in the field: defining painful disease
states and syndromes along with delineating
appropriate therapy as shown by a
comparison of the Merck Manual in 1999, the
Centennial Edition, with the indices for pain
and analgesics in the original Merck Manual
published in 1899.
INDICATIONS.
Pain.-See also, AfterPains, Anesthesia, Boils, Chest Pains, Colic, Gastralgia,
Headache, Hepatalgia, lnflammat i o n , Lumbago, Myalgia, Neuralgia, Neuritis.
Odontalgia, Otalgia, Ovarian Neuralgia, Rheumatisrn, etc. Also lists of Analgesics,
Anesthetics and Narcotics
Analgesia
in acute post-operative pain, 1370- in neuropathic pain syndromes,
1371 1371-1373
in cancer pain syndromes, 1371 nonopioid drugs for, 1364-1365,
in dying patient, 2510-2511 1364t
in elderly, 2602t; 26041, 2610 NSAIDs for, 13641365, 1364t
fetal effects of, 2024
opioid drugs for, 1365-1370,-
for labor, 2028
1366t,1368t
in migraine, 1377, 1377t
in tension headache, 1378
nephrotoxicity of, 1878, 1880t,
1881,1882t
However far we have come in furthering
our description of disease states, as you can
see many of the drugs used 100 years ago
remain the drugs we use today:
opiates
NSAIDs
sedatives
muscle relaxants
Various Descriptors of Pain
Mild: ??
Moderate: ??
Severe: ??
Although descriptive, does not provide rigor:
perhaps these should be used to modify acute and
chronic pain indications to allow patients to
understand, but how do you measure what is mild,
moderate, severe: ultimately it is the bias of the
agency, investigators, sponsors to suggest which
is which.
Various Descriptors of Pain
Loneliness Hostility
Social Factors
Anxiety Depression
Psychological Factors
Pathological Process
Physical Factors