Nimesulide Versus Ibuprofen for Postoperative Tonsillectomy Pain
Nimesulide Versus Ibuprofen for Postoperative Tonsillectomy Pain
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.
Tonsillectomy is one of the most common ear, nose and throat surgical procedures, and in many institutions it is carried out as a short-stay operation. Unfortunately, tonsillectomy is often associated with intense pain that may not only delay discharge but may also influence the patient's ability to return to normal daily activities. Patients may even be reluctant to eat and drink due to painful dysphagia. To allow a smooth recovery and a peaceful return to normal activities, treatment of pain after tonsillectomy should be effective.
Despite increasing demands for postoperative well-being, recent studies indicate that treatment of pain after tonsillectomy is often inadequate. Opioids are widely used analgesics for peri- and postoperative pain. However, the known adverse effects of these drugs, such as emesis, excessive sedation and risk of respiratory depression, may lead to their underuse.
Nonsteroidal anti-inflammatory drugs (NSAIDs) are highly effective for treatment of acute pain. NSAIDs have been shown to reduce or even eliminate the need for postoperative opioids. The likely mechanism of action by which NSAIDs exert their analgesic effect is by inhibition of cyclo-oxygenase (COX)-mediated prostaglandin synthesis. COX is responsible for the generation of prostaglandins. Two isoforms, COX-1 and COX-2, have been identified. COX-2 is the isoform of the enzyme that is induced by pro-inflammatory stimuli and is postulated to be responsible for the synthesis of prostanoid mediators of acute pain and inflammation.
The use of NSAIDs during tonsillectomy is controversial, because NSAIDs may prolong the bleeding time by inhibiting biosynthesis of thromboxane A2 and can therefore increase blood loss during and after surgery. Traditional NSAIDs such as ibuprofen inhibit both COX-1 and COX-2 and this non-selective inhibition is presumed to be the reason for the occurrence of their characteristic adverse effects, for example inhibition of platelet aggregation. At therapeutic doses preferential COX-2 selective inhibitors such as nimesulide inhibit less COX-1, thereby preserving COX-1-dependent physiological processes in tissues. Platelets do not express COX-2, thus, at least in theory, nimesulide should alter platelet function less and reduce bleeding during tonsillectomy compared with ibuprofen.
The aim of the present study was to compare the efficacy and safety of nimesulide with ibuprofen in the treatment of pain after tonsillectomy. The study hypothesis was that the analgesic efficacy of nimesulide and ibuprofen is similar but that nimesulide may aggravate less bleeding than ibuprofen.
The primary endpoint for the study was the need for rescue analgesics during the first 24 hours after surgery and the incidence of primary and secondary significant bleeding. Secondary endpoints were the time to the first dose of rescue analgesia, the duration of pain after surgery, the recovery of normal daily functions, and the incidence of adverse events.
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.
Tonsillectomy is one of the most common ear, nose and throat surgical procedures, and in many institutions it is carried out as a short-stay operation. Unfortunately, tonsillectomy is often associated with intense pain that may not only delay discharge but may also influence the patient's ability to return to normal daily activities. Patients may even be reluctant to eat and drink due to painful dysphagia. To allow a smooth recovery and a peaceful return to normal activities, treatment of pain after tonsillectomy should be effective.
Despite increasing demands for postoperative well-being, recent studies indicate that treatment of pain after tonsillectomy is often inadequate. Opioids are widely used analgesics for peri- and postoperative pain. However, the known adverse effects of these drugs, such as emesis, excessive sedation and risk of respiratory depression, may lead to their underuse.
Nonsteroidal anti-inflammatory drugs (NSAIDs) are highly effective for treatment of acute pain. NSAIDs have been shown to reduce or even eliminate the need for postoperative opioids. The likely mechanism of action by which NSAIDs exert their analgesic effect is by inhibition of cyclo-oxygenase (COX)-mediated prostaglandin synthesis. COX is responsible for the generation of prostaglandins. Two isoforms, COX-1 and COX-2, have been identified. COX-2 is the isoform of the enzyme that is induced by pro-inflammatory stimuli and is postulated to be responsible for the synthesis of prostanoid mediators of acute pain and inflammation.
The use of NSAIDs during tonsillectomy is controversial, because NSAIDs may prolong the bleeding time by inhibiting biosynthesis of thromboxane A2 and can therefore increase blood loss during and after surgery. Traditional NSAIDs such as ibuprofen inhibit both COX-1 and COX-2 and this non-selective inhibition is presumed to be the reason for the occurrence of their characteristic adverse effects, for example inhibition of platelet aggregation. At therapeutic doses preferential COX-2 selective inhibitors such as nimesulide inhibit less COX-1, thereby preserving COX-1-dependent physiological processes in tissues. Platelets do not express COX-2, thus, at least in theory, nimesulide should alter platelet function less and reduce bleeding during tonsillectomy compared with ibuprofen.
The aim of the present study was to compare the efficacy and safety of nimesulide with ibuprofen in the treatment of pain after tonsillectomy. The study hypothesis was that the analgesic efficacy of nimesulide and ibuprofen is similar but that nimesulide may aggravate less bleeding than ibuprofen.
The primary endpoint for the study was the need for rescue analgesics during the first 24 hours after surgery and the incidence of primary and secondary significant bleeding. Secondary endpoints were the time to the first dose of rescue analgesia, the duration of pain after surgery, the recovery of normal daily functions, and the incidence of adverse events.
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