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Letters to the Editor Indian Pediatrics 2002; 39:886-867 |
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Efficacy of Nimesulide in Pain Relief after Day Care Surgery |
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I have certain queries and concerns regarding the article(1) published in Indian Pediatrics. How soon post-operatively was the first dose of the drug given and were the drugs were given round the clock or only on a need basis? The type of anesthesia used is not mentioned and this would obviously affect the appearance and extent of pain during the first few hours after surgery. The authors have mentioned that the efficacy of treatment was evaluated by physiological responses, wound hyperthermia and pain behavior. Since this study was done on day care patients it is assumed that they were sent home after a few hours. Who assessed these parameters at home and were they incorporated into the final scores? As we know, facial expression scores are ambiguous at the best and difficult to appreciate in a crying child. The revised pain scale, which has been validated for children between 4-16 years and is based on how a child feels rather than how the face looks, would have been more appropriate(2). Since the study was blinded, I would also like to know who provided the paracetamol to the control group (sponsors or investigators) and why randomization was not done, as the type of surgery would also have affected the degree of pain. Lastly, though there is no information on any side effects in the study population, > 50% were lost to follow-up and hence it is difficult to comment on the safety of the drug. Finally and most importantly, we know that there is controvery regarding Nimesulide which is still not approved by USFDA, Canada, UK, Australia, New Zealand and the Scandinavian countries. It is pertinent to mention that countries like Portugal have withdrawn the drug for Pediatric use since 1999. Developing countries like Sri Lanka have still not approved the drug mainly because they prefer to go along with the USFDA. The study was funded by Panacea Biotec which is a leading manufacturer of the drug in India. Any new drug should be assessed with caution. As responsible members of the medical fraternity in India, where new drugs are readily approved, we need to be careful not to allow competing interests to potentially affect our scientific evaluation(3). Sheila Mathai, 50, Gangotri, Near Afghan Church, Colaba, Mumbai 400 005, India. E-mail: [email protected] . |
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