Conditions: Pain
Keywords: Post-Surgical Pain Bunionectomy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 322
Healthy volunteers: no

Brief summary:
The primary objective of this trial is to evaluate analgesic efficacy of Buprenorphine Sublingual (under the tongue) Spray compared with placebo in participants with postoperative pain after bunionectomy.

Detailed description:

Arms:
arm 1: Participants received buprenorphine 0.5 mg sublingual (under the tongue) spray three times daily (TID) for two days. arm 2: Participants received buprenorphine 0.25 mg sublingual spray TID for two days. arm 3: Participants received buprenorphine 0.125 mg sublingual spray TID for two days. arm 4: Participants received placebo-matching buprenorphine sublingual spray TID for two days.

Interventions: intervention 1: Buprenorphine intervention 2: Placebo
Intervention descriptions: intervention 1: Buprenorphine sublingual spray delivered via single 100 μL spray intervention 2: Placebo-matching buprenorphine sublingual spray delivered via single 100 μL spray

Protocol document: