NCT00598702

Study of the Safety & Efficacy of Intravenous Acetaminophen in Pediatric Inpatients

A Phase III Multi-Center, Open-Label, Prospective, Repeated Dose, Multi-Day Study of the Safety & Efficacy of Intravenous Acetaminophen in Pediatric Inpatients.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Mallinckrodt · Industry
• Sex: All
• Age: 37 Weeks – 16 Years
• Healthy volunteers: Not accepted

Summary

Intravenous acetaminophen (IVAPAP) is safe in repeated dose, multi-day clinical use when administered at a daily dose of 40 to 75 mg/kg body weight

Detailed description

To assess the safety of intravenous acetaminophen (IV APAP) when used over one or more days for the treatment of acute pain or fever in pediatric (neonates, infants, children and adolescents) inpatients who are unable to take anything by mouth (NPO), require or would benefit from IV treatment, or are willing and able to stay on IVAPAP therapy for 1 to 7 days.

Conditions

• Pain
• Fever

Interventions

Type	Name	Description
DRUG	IV Acetaminophen	Target is 1 to 7 days of therapy with intravenous (IV) Acetaminophen (IV APAP) at a dose of 40 to 75 mg/kg body weight/day administered as an IV infusion (or by syringe pump) over 15 minutes and given every 4 to 6 hours as a scheduled dose

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-12-01
• Completion: 2009-01-01
• First posted: 2008-01-22
• Last updated: 2017-05-10
• Results posted: 2011-01-06

Locations

14 sites across 1 country: United States