At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 197 enrolled
Drug / intervention
IV Acetaminophen +1 moredrug
Likely dose
Not stated in 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 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
In Brief
A Phase 3 clinical trial evaluating IV Acetaminophen and IV Control for Acute Pain. Completed, enrolled 197 participants across 22 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Pain
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2012
First PostedJul 2012
Primary CompletionAug 2015
Study CompletionNov 2015
TodayJul 2026
First PostedJul 6, 2012
Enrollment StartJun 1, 2012
Primary CompletionAug 1, 2015
Study CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 14.0 years ago
Interventions
IV Acetaminophendrug
IV Acetaminophen given every 6 hours (q6h); 4 doses, in 24 hours
IV Controldrug
IV Control q6h; 4 doses, in 24 hours