Efficacy and Tolerability of Nonprescription Ibuprofen versus Celecoxib for Dental Pain

Doyle G, Jayawardena S, Ashraf E, Cooper SA

This study was designed to compare the efficacy and safety of an OTC analgesic, ibuprofen, to the leading prescription COX-2 inhibitor celecoxib. It has been claimed that COX-2 inhibitors are associated with fewer incidences of harmful gastrointestinal effects than traditional nonsteroidal anti-inflammatory analgesic agents (NSAIDS) such as ibuprofen, while equally effective as a pain reliever. Results from past studies on the chronic use of COX-2 inhibitors and nonspecific NSAIDS among arthritis sufferers appear to support this claim, but there was no data demonstrating how the two medications compared among the general population. The oral surgery impaction pain model was used in this study because of its established assay sensitivity and applicability to the OTC environment. During a 12-hour period, a placebo, ibuprofen liquigels (400 mg), and celecoxib (200 mg) were each given at baseline and again at four and eight hours to simulate a realistic post-surgical clinical situation. The study design was inpatient, multiple dose, randomized (stratified by baseline pain and gender), placebo controlled, double blind, double dummy, and parallel group with an evaluation period of 12 hours. Patients, both male and female, were required to undergo surgical removal of one or more impacted third molars. At least one of the impacted teeth had to have been a mandibular third molar partially embedded in bone to ensure adequate post-surgical pain. Age was limited to between 16 and 65 years of age. Preoperative medications or anesthetics were limited. After the extractions, patients were required to have at least moderate pain (quantitatively and qualitatively verified). Patients with a serious medical condition or other special considerations were excluded from the study. Efficacy was assessed by having patients evaluate pain severity on a four-point categorical scale at timed intervals. Patients then evaluated relief from baseline pain on a five-point categorical scale. Patients also used stopwatches to record the exact times of "first perceptible" and "meaningful" pain relief. At the conclusion of the 12-hour evaluation period, patients provided overall evaluations of the study medication on a five-point categorical scale. Differences in pain relief and pain intensity were measured to determine how effective and fast-acting each study drug was. Safety was studied by recording all adverse events observed by the coordinator or reported by patients, severity of each event, and the event's relationship with the study drug. Adverse reactions were then tabulated and summarized by the COSTART term and body system and compared among the study drugs. The authors concluded that both ibuprofen liquigels and celecoxib were significantly better than placebo at relieving pain, while the liquigels were significantly more effective than celecoxib at all time points except those just prior to or at the scheduled second and third doses. Ibuprofen liquigels were also reported to act significantly faster and offer pain relief significantly longer than celecoxib. Incidence rates of adverse events were comparable among all three study arms; all adverse events were rated as mild or moderate in severity. Gastrointestinal adverse events were reported to happen more often with celecoxib than with ibuprofen liquigels. According to these researchers, ibuprofen liquigels provide faster and better analgesic efficacy to the general population without any apparent increased safety risk. J Clin Pharmacol 2002 April;42:912-919. Return to Top