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It was encouraging to
read the article on efficacy of nimesulide in pain relief after day care
surgery(1). We do appreciate the concept of day care surgery and
appropriate analgesia, still in its nascent stage in our country. We
would like to offer following comments.
(a) The study
was a double blind controlled clinical trial. However there are few
factors which could have led to biased observations. The factor of
randomization has been noted by the authors. Second bias factor
relates to dispensing of the two drugs used in the study. Syrup
paracetamol is dispensed as 125 mg/5 mL and syrup nimesulide as 50
mg/5 mL. The dose of the drugs recommended is 10 mg/kg, 1.5 mg/kg
respectively. So a 10 kg child either gets 4 mL of paracetemol or 1.5
mL of nimesulide. With this much of difference in the volume of drugs
dispensed, how was the "blinding" ensured. Thirdly in a
study which requires observer’s inference, it would be appropriate
to have two independent observers.
(b) Does day
care surgery imply discharge on the day of surgery itself? If so,
children included in the study were given analgesics for a mean period
of three days at home. The authors need to clarify whether all the 100
children enrolled in the study were discharged on the day of surgery.
If affirmative, pain relief assessment was limited to a single
observation during immediate post operative period. Hence, whether the
pain scores were repeated after the subsequent doses needs to be
clarified.
(c)
Pharmacokinetic profile of the two drugs is different in children.
Following oral administration, paracetamol reaches peak concentrations
in plasma in 30-60 minutes and nimesulide achieves peak
concen-trations within 2 hours(2). The duration of action of
paracetamol and nimesulide is 6 hr and 8-10 hr respectively. A single
recording of pain score 30 minutes after drug administration may not
show the best analgesic response for two drugs.
(d) A dropout
rate of 58% is very significant for any scientific study on the safety
of a drug like nimesulide which still remains to be cleared for
routine use in children. With the increasing use of nimesulide,
concerns have been raised regarding its hepato-toxicity. Deaths due to
fulminant hepatic failure have been attributed to nimesulide(3).
Daljit Singh,
T.S. Raghuraman,
Department of Pediatrics,
Command Hospital, Air
Force,
Bangalore 560 007,
Karnataka,
India.
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