NCT01635101

A Multi-Center Study of the Efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) of IV Acetaminophen for the Treatment of Acute Pain in Pediatric Patients

A Randomized, Placebo Controlled, Multi-Center Study of the Efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) of IV Acetaminophen for the Treatment of Acute Pain in Pediatric Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 197 (actual)
• Sponsor: Mallinckrodt · Industry
• Sex: All
• Age: 1 Day – 2 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate the efficacy and safety of Intravenous (IV) acetaminophen plus rescue opioids for the relief of moderate to severe acute pain in neonates and infants (age \< 2 years) compared to placebo plus standard of care rescue opioids as well as characterize the concentration-effect relationship (PK/PD) of the intravenous acetaminophen as compared to the control group.

Conditions

• Acute Pain

Interventions

Type	Name	Description
DRUG	IV Acetaminophen	IV Acetaminophen given every 6 hours (q6h); 4 doses, in 24 hours
DRUG	IV Control	IV Control q6h; 4 doses, in 24 hours

Timeline

• Start date: 2012-06-01
• Primary completion: 2015-08-01
• Completion: 2015-11-01
• First posted: 2012-07-06
• Last updated: 2020-01-21
• Results posted: 2020-01-21

Locations

22 sites across 1 country: United States