IBUPROFEN CONTROLLED-RELEASE FORMULATION - A CLINICAL-TRIAL IN DENTALIMPACTION PAIN

This double-blind study compared a controlled-release formulation of i buprofen 600 mg with three doses of regular ibuprofen 200 mg and three doses of codeine 30 mg. Patients who had dental impaction surgery rec eived the controlled-release ibuprofen, codeine, or regular ibuprofen when postoperative pain reached moderate to severe intensity. At 4 and 8 hours after dose 1, patients who had initially received the control led-release ibuprofen received a placebo, and those taking ibuprofen a nd codeine received their second and third doses of those drugs. All d oses of study medication or placebo appeared identical for each treatm ent. Subjects made evaluations hourly for 12 hours in a diary. The con trolled-release ibuprofen had a comparable onset to ibuprofen, a highe r peak effect, and was significantly more effective than ibuprofen at hour 4; the controlled-release ibuprofen was significantly more effect ive than codeine for all hourly observations through hour 9. Ibuprofen was significantly better than codeine only through hour 3. The contro lled-release ibuprofen had the lowest incidence of side effects and co deine the highest. The single dose of the controlled-release ibuprofen formulation appeared as efficacious as three regular doses of ibuprof en 200 mg over a 12-hour period.