Conditions: Pain, Post-operative
Keywords: Bunion Bunionectomy Pain Analgesia dexmedetomidine intranasal
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 95
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the analgesic efficacy of two dose levels 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 35mcg every 6 hours for 48 hours. DEX-IN 35mcg PRN for up to 3 additional days. arm 2: DEX-IN 50mcg every 6 hours for 48 hours. DEX-IN 50mcg PRN for up to 3 additional days. arm 3: IN Placebo every 6 hours for 48 hours. IN Placebo PRN for up to 3 additional days.

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

Protocol document: