A dose-ranging study of bromfenac sodium in oral surgery pain.

Abstract

OBJECTIVE:

The purpose of this study was to evaluate the analgesic efficacy and safety of five graded doses of bromfenac sodium in patients experiencing moderate to severe pain after the surgical removal of impacted third molar teeth.

STUDY DESIGN:

The study employed a randomized, double-blind, single-dose, 8-hour, inpatient evaluation period. The treatment groups included placebo (n = 21) and bromfenac (n = 102) at dosage strengths of 5 mg (n = 21), 25 mg (n = 20), 50 mg (n = 20), 100 mg (n = 20), and 200 mg (n = 21). Patients ingested a dose of study medication when their postsurgical pain reached a moderate or severe intensity. Pain intensity and pain relief were rated at 15, 30, 60, 90, and 120 minutes and then hourly for the remaining 6 hours. Efficacy and safety variables were analyzed by means of analysis of variance and chi-squared tests where appropriate.

RESULTS:

At all doses, bromfenac exhibited statistical superiority (p < 0.05) to placebo, with all but the 5-mg dose being significantly more efficacious for every summary analgesic measure (3- and 8-hour sum pain intensity difference and sum pain analog intensity difference, total pain relief, peak effects, sum of pain half gone, and global evaluation). Peak analgesic effects did not increase beyond those provided by the 25-mg dose of bromfenac, although both the 100- and 200-mg bromfenac doses provided a more rapid onset and a longer duration of analgesia than either the 25- or 50-mg dosage strengths. The most common side effects reported were headache, nausea, dizziness, and drowsiness; the incidence in the bromfenac group was no different from that in the placebo group.

CONCLUSIONS:

Bromfenac is a safe and efficacious analgesic, with a threshold dose of 5 mg and a positive dose-response up to 25 mg for peak effects and 100 mg for total analgesic activity.

• Authors: E V Hersh, S A Cooper, L M Levin, N J Betts, D Wedell, C Lamp, J Wajdula
• Journal: Oral surgery, oral medicine, oral pathology, oral radiology, and endodontics (Oral Surg Oral Med Oral Pathol Oral Radiol Endod) Vol. 86 Issue 1 Pg. 36-41 (Jul 1998) ISSN: 1079-2104 [Print] United States
• PMID: 9690243 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Analgesics
• Benzophenones
• Bromobenzenes
• Placebos
• bromfenac

Topics

• Adult
• Analgesics (administration & dosage, adverse effects, therapeutic use)
• Analysis of Variance
• Benzophenones (administration & dosage, adverse effects, therapeutic use)
• Bromobenzenes (administration & dosage, adverse effects, therapeutic use)
• Chi-Square Distribution
• Dizziness (chemically induced)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Evaluation Studies as Topic
• Female
• Follow-Up Studies
• Headache (chemically induced)
• Humans
• Incidence
• Male
• Molar, Third (surgery)
• Nausea (chemically induced)
• Pain Measurement
• Pain, Postoperative (drug therapy)
• Placebos
• Safety
• Sleep Stages (drug effects)
• Time Factors
• Tooth Extraction
• Tooth, Impacted (surgery)