At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 100 enrolled
Drug / intervention
IV Acetaminophendrug
Likely dose
IV Acetaminophen 75 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Multi-Center, Open-Label, Prospective, Repeated Dose, Multi-Day Study of the Safety & Efficacy of Intravenous Acetaminophen in Pediatric Inpatients.
In Brief
A Phase 3 clinical trial evaluating IV Acetaminophen for Pain and Fever. Completed, enrolled 100 participants across 14 sites.
Detailed 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
Study Details
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2008
First PostedJan 2008
Primary CompletionDec 2008
Study CompletionJan 2009
TodayJul 2026
First PostedJan 22, 2008
Enrollment StartJan 1, 2008
Primary CompletionDec 1, 2008
Study CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 18.4 years ago
Interventions
IV Acetaminophendrug
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