NCT00399568

Efficacy and Safety of Intravenous Acetaminophen Over 48 Hrs for the Treatment of Post-op Pain After Gynecologic Surgery

Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel, Multiple-Dose Study of the Analgesic Efficacy and Safety of IV Acetaminophen (APAP) Versus Placebo Over 48 Hours(Hrs) for the Treatment of Postoperative Pain After Gynecologic Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 331 (actual)
• Sponsor: Mallinckrodt · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will be investigating the efficacy and safety administration of multiple doses of intravenous (IV) acetaminophen (IVAPAP) in the 48 hour period following Gynecologic Surgery.

Detailed description

The research hypothesis is that IV Acetaminophen will provide greater reduction in pain intensity and greater pain relief for moderate and severe pain as compared to placebo in the 48 hours following surgery.

Conditions

• Postoperative Pain
• Hysterectomy

Interventions

Type	Name	Description
DRUG	IV Acetaminophen	Intravenous acetaminophen 1 g/100 mL
DRUG	IV Placebo 100 mL solution	IV Placebo 100 mL solution dosed at same frequency as IV Acetaminophen every 6 hours (q6h)

Timeline

• Start date: 2006-11-01
• Primary completion: 2007-09-01
• Completion: 2007-09-01
• First posted: 2006-11-15
• Last updated: 2016-10-21
• Results posted: 2010-12-10

Locations

27 sites across 1 country: United States