Nimesulide versus ibuprofen for postoperative tonsillectomy pain - A double-blind, randomised, active comparator-controlled clinical trial

Background and objective: Nonsteroidal anti-inflammatory drugs are effective analgesics but their use during tonsillectomy is controversial because of the risk of postoperative bleeding. The aim of this study was to compare the analgesic efficacy and safety of nimesulide, a preferential cyclo-oxygenase type-2 inhibitor, with ibuprofen in the treatment of pain after tonsillectomy. Study design: A prospective, double-blind, randomised clinical trial. Patients and methods: A total of 80 consenting generally healthy patients, aged 14-58 years, undergoing tonsillectomy were randomly assigned to receive either nimesulide 100mg or ibuprofen 800mg orally 60 minutes before surgery. Subsequent doses of the same study medication were administered at 12-hour intervals for the first 7 days, and thereafter when needed. During the first 24 postoperative hours in hospital oxycodone was used for rescue analgesia, and after discharge patients were allowed to use a paracetamol-codeine combination for breakthrough pain. Recovery was recorded up to 3 weeks after surgery. Results: The need for rescue analgesia during the first 24 hours was similar in the two study groups; 0-7 doses (mean +/- SD 3.3 +/- 1.7 doses) in the nimesulide group and 0-11 doses (3.3 +/- 2.4 doses) in the ibuprofen group. After discharge significant differences were found between the two study groups in favour of the nimesulide-treated patients. Cessation of significant pain while swallowing occurred after 3-19 (10.9 +/- 3.8) days in the nimesulide group versus 7-20 (12.9 +/- 3.3) days in the ibuprofen group (p = 0.041), and return to normal daily activities occurred after 3-21 (10.3 +/- 4.9) days in the nimesulide group versus after 3-19 (12.7 +/- 4.2) days in the ibuprofen group (p = 0.048). At 3 weeks, six of 33 patients in the nimesulide group versus 15 of 37 patients in the ibuprofen group had pain during swallowing (p = 0.049). One patient (3%) in the nimesulide group and five patients (12%) [p = 0.22] in the ibuprofen group needed electrocautery to stop postoperative bleeding. Conclusion: Oral nimesulide was as effective as ibuprofen in pain management after tonsillectomy, and nimesulide improved the recovery after discharge.