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Letters to the Editor

Indian Pediatrics 2002; 39:978

Efficacy of Nimesulide in Pain Relief after Day Care Surgery


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 observerís 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.

References


1. Harish J, Chowdhary SK, Narasimhan KL, Mahajan JK, Rao KLN. Efficacy of nimesulide in pain relief after day care surgery. Indian Pediatr 2002; 39: 178-182.

2. Ugazio A, Guarnaccia S, Berardi M, Renzetti I. Clinical and pharmacokinetic study of nimesulide in children. Drugs 1993; 46 Suppl 1: 215-218.

3. Malhotra S, Pandhi P. Analgesics for pediatric use. Indian J Pediatr 2000; 67: 589-590.

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