Placebo-Controlled Evaluation of Intranasal Dexmedetomidine for Postoperative Analgesia Following Bunionectomy Surgery

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.

Timeline

Start

2014-10

Primary completion

2015-06

Completion

2015-06

Outcome

Met primary endpoint

registry analysis (superiority or other test); DEX-IN 50mcg vs IN Placebo; p = 0.0180; ANCOVA NCT02284243 ↗

Drugs

Indications

No indication recorded.