EVALUATION OF BROMFENAC AND IBUPROFEN FOR PAIN AFTER ORTHOPEDIC-SURGERY

Study Objectives. To determine the relative analgesic potency and adve rse effect liability of bromfenac 25, 50, and 100 mg, and ibuprofen 20 0 and 400 mg in the treatment of postoperative pain after orthopedic D esign. Randomized, double-blind, single-dose, parallel-group relative potency assay with evaluations at 30 minutes and then at hourly interv als for up to 6 hours, Setting. Two wards of the orthopedic surgery de partment at the Centralsjukhuset (Central Hospital) in Karlstad, Swede n. Patients. Two hundred inpatients with steady, moderate or severe pa in within 72 hours after orthopedic surgery. Interventions. Patients r eceived a single oral dose of bromfenac 25, 50, or 100 mg, or ibuprofe n 200 or 400 mg, when they experienced steady, moderate or severe pain that, in their opinion, required an analgesic. Using a self-rating re cord, subjects rated their pain and its relief for 6 hours after medic ating. Measurements and Main Results. The study was a valid relative p otency assay with estimates of bromfenac's potency relative to ibuprof en ranging from 10.9 (nurse's global evaluation) to 16.7 (sum of hourl y analog pain intensity difference scores). That is, 11-16 times the d ose of ibuprofen must be administered to equal the analgesic effect of bromfenac. Patients who had eaten breakfast or lunch within 60 minute s before or 30 minutes after receiving the study medication (''fed'' p atients) had lower efficacy scores than those who had not ingested foo d within these time constraints before or after receiving the study me dication (''fasted' patients). Furthermore, patients who had eaten bef ore receiving the study medication had significantly lower efficacy sc ores than those who had eaten after receiving the study medication. Co nclusions. The relative potency of the analgesic effect of bromfenac t o ibuprofen is 11-16.7 in patients with pain after orthopedic surgery. Fed patients may have lower analgesic efficacy than fasted patients. Adverse effects for both bromfenac and ibuprofen were transient and co nsistent with the pharmacologic profiles of the drugs.