Evaluation of ketorolac, ibuprofen-paracetamol, and dextropropoxyphene-paracetamol in postoperative pain.

Author(s): Naidu MU, Kumar TR, Jagdishchandra US, Babu PA, Rao MM, Babhulkar SS, Rao PT, Risbud Y, Shah R

Affiliation(s): Department of Clinical Pharmacology and Therapeutics, Nizam's Institute of Medical Sciences, Punjagutta, Hyderabad, India.

Publication date & source: 1994-03, Pharmacotherapy., 14(2):173-7.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

STUDY OBJECTIVE. To compare the analgesic efficacy of ketorolac, ibuprofen-paracetamol (acetaminophen), and dextropropoxyphene-paracetamol in postoperative pain. DESIGN. Randomized, double-blind, parallel, single-dose study. SETTING. Multicenter, with five centers participating. PATIENTS. One hundred sixty patients with moderate to severe postoperative pain requiring oral analgesics were enrolled. Seventeen patients were excluded from final analysis due to deviation from protocol. INTERVENTIONS. Ketorolac tromethamine 10 mg, a combination of ibuprofen 400 mg plus paracetamol 325 mg, or a combination of dextropropoxyphene 65 mg plus paracetamol 400 mg was given orally to patients with moderate to severe baseline pain. MEASUREMENTS AND MAIN RESULTS. Pain intensity and pain relief scores were rated at baseline, at 30 minutes, and hourly to 6 hours. Until the end of first hour, analgesia was similar for all three regimens. Ketorolac had a significantly higher analgesic effect than the two combinations between hours 2 and 6. Analgesia was similar for the two combinations. For all three test drugs the frequency of adverse effects was similar. CONCLUSIONS. Ketorolac 10 mg is a superior analgesic to ibuprofen-paracetamol or dextropropoxyphene-paracetamol in the treatment of postoperative pain.