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


METHODS
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.
University of Pennsylvania School of Dental Medicine, Philadelphia, USA.
E V
EV
Hersh
S A
SA
Cooper
L M
LM
Levin
N J
NJ
Betts
D
D
Wedell
C
C
Lamp
J
J
Wajdula
D000328:Adult; D000700:Analgesics / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000704:Analysis of Variance; D001577:Benzophenones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001969:Bromobenzenes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D004244:Dizziness / Q000139:chemically induced; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005069:Evaluation Studies as Topic; D005260:Female; D005500:Follow-Up Studies; D006261:Headache / Q000139:chemically induced; D006801:Humans; D015994:Incidence; D008297:Male; D008964:Molar, Third / Q000601:surgery; D009325:Nausea / Q000139:chemically induced; D010147:Pain Measurement; D010149:Postoperative Pain / Q000188:drug therapy*; D010919:Placebos; D012449:Safety; D012894:Sleep Stages / Q000187:drug effects; D013997:Time Factors; D014081:Tooth Extraction; D014095:Tooth, Impacted / Q000601:surgery
D000700:Analgesics; D001577:Benzophenones; D001969:Bromobenzenes; D010919:Placebos; C053083:bromfenac