PURPOSE: The purpose of the study was to compare the preemptive analgesic effect of celecoxib, a cyclooxygenase 2 inhibitor, with a traditional nonsteroidal anti-inflammatory drug, ibuprofen, in patients after minor oral surgery procedures. PATIENTS AND METHODS: This randomized, double-blind, placebo-controlled, prospective clinical trial was conducted over an 8-month period. Participants were randomly allocated to receive a standard oral dose of 200 mg celecoxib, 400 mg ibuprofen, or a placebo containing lactose, preemptively 1 h before surgery. Using a patient diary, patients recorded pain intensity, pain relief, and global evaluations throughout the 24-hour period after dosing. The overall analgesic effect, onset of action, peak effect, and duration of effect were evaluated, with the primary end point being total pain relief over 8 hours. The safety profile was assessed on the basis of physical findings and spontaneous reports of adverse experiences. RESULTS: The results showed that compared with ibuprofen, celecoxib had superior analgesic effects on all measures of analgesic efficacy, including overall analgesic effect (total pain relief over 8 hours: 18.1 vs 12.2, P < 0.001), time to onset of effect (30 vs 60 minutes, P = 0.003), peak pain relief (score, 2.7 vs 2.4, P < 0.05), and duration of effect (>24 vs 7.0 hours, P < 0.001). The safety profile was similar across all treatment groups. CONCLUSIONS: This is the first reported study that demonstrates the superior analgesic effect of celecoxib, for the release of acute postoperative pain following surgery, when compared with the traditional nonsteroidal anti-inflammatory drug, ibuprofen. There was no safety compromise when celecoxib was used in lower doses to provide analgesia for patients who need minor surgery.
RCT Entities:
PURPOSE: The purpose of the study was to compare the preemptive analgesic effect of celecoxib, a cyclooxygenase 2 inhibitor, with a traditional nonsteroidal anti-inflammatory drug, ibuprofen, in patients after minor oral surgery procedures. PATIENTS AND METHODS: This randomized, double-blind, placebo-controlled, prospective clinical trial was conducted over an 8-month period. Participants were randomly allocated to receive a standard oral dose of 200 mg celecoxib, 400 mg ibuprofen, or a placebo containing lactose, preemptively 1 h before surgery. Using a patient diary, patients recorded pain intensity, pain relief, and global evaluations throughout the 24-hour period after dosing. The overall analgesic effect, onset of action, peak effect, and duration of effect were evaluated, with the primary end point being total pain relief over 8 hours. The safety profile was assessed on the basis of physical findings and spontaneous reports of adverse experiences. RESULTS: The results showed that compared with ibuprofen, celecoxib had superior analgesic effects on all measures of analgesic efficacy, including overall analgesic effect (total pain relief over 8 hours: 18.1 vs 12.2, P < 0.001), time to onset of effect (30 vs 60 minutes, P = 0.003), peak pain relief (score, 2.7 vs 2.4, P < 0.05), and duration of effect (>24 vs 7.0 hours, P < 0.001). The safety profile was similar across all treatment groups. CONCLUSIONS: This is the first reported study that demonstrates the superior analgesic effect of celecoxib, for the release of acute postoperative pain following surgery, when compared with the traditional nonsteroidal anti-inflammatory drug, ibuprofen. There was no safety compromise when celecoxib was used in lower doses to provide analgesia for patients who need minor surgery.
Authors: Fábio Wildson Gurgel Costa; Diego Felipe Silveira Esses; Paulo Goberlânio de Barros Silva; Francisco Samuel Rodrigues Carvalho; Carlos Diego Lopes Sá; Assis Filipe Medeiros Albuquerque; Tácio Pinheiro Bezerra; Thyciana Rodrigues Ribeiro; Cristiane Sá Roriz Fonteles; Eduardo Costa Studart Soares Journal: Anesth Prog Date: 2015
Authors: Faizah Safina Bakrin; Mohd Makmor-Bakry; Wan Hazmy Che Hon; Shafeeq Mohd Faizal; Mohamed Mansor Manan; Long Chiau Ming Journal: Pharmacy (Basel) Date: 2020-12-08