Conditions: Pain, Post-operative
Keywords: Bunion Bunionectomy Pain Analgesia dexmedetomidine intranasal
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 168
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the analgesic efficacy, on Post-Operative Day (POD) 1, of DEX-IN compared with placebo, using the summed pain intensity difference over the first 48 hours (SPID48) in subjects with acute moderate to severe pain following unilateral bunionectomy.

Detailed description:

Arms:
arm 1: DEX-IN (Intranasal dexmedetomidine) 50mcg every 6 hours for 48 hours. arm 2: IN Placebo every 6 hours for 48 hours.

Interventions: intervention 1: Intranasal Dexmedetomidine intervention 2: Intranasal Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: