NCT00564486

Analgesic Efficacy & Safety of Intravenous (IV) Acetaminophen Versus Placebo for the Treatment of Postop Pain

Phase 3 Randomized, Double-Blind Placebo-Controlled, Multicenter, Parallel-Group, Repeated-Dose Study of the Analgesic Efficacy & Safety of IV Acetaminophen Versus Placebo for the Treatment of Postop Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 244 (actual)
• Sponsor: Mallinckrodt · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This research study will look at the pain relieving ability and safety of using repeated doses of intravenous (into the vein \[IV\]) acetaminophen in the treatment of moderate postoperative pain after planned or elective abdominal laparoscopic surgery, such as a laparoscopic abdominal hysterectomy or laparoscopic cholecystectomy (removal of the gall bladder).

Detailed description

To assess the analgesic efficacy of repeated doses of intravenous acetaminophen (IV APAP) versus Placebo in the treatment of moderate postoperative pain after abdominal laparoscopic surgery.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	IV Placebo	IV, every 6 hours for 24 hours (4 doses total)
DRUG	IV Placebo	IV, every 4 hours for 24 hours (6 doses total)
DRUG	IV Acetaminophen	IV, every 6 hours for 24 hours (4 doses total)
DRUG	IV Acetaminophen	IV, every 4 hours for 24 hours (6 doses total)

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2007-11-28
• Last updated: 2016-10-21
• Results posted: 2010-11-30

Locations

17 sites across 1 country: United States