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

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.

Timeline

Start

2012-06

Primary completion

2015-08

Completion

2015-11

Outcome

Missed primary endpoint

registry analysis (other test); Low Dose Acetaminophen vs Placebo; p = 0.736; LS Mean Difference -11.8 (97.5% CI -91.0 to 67.3); ANOVA NCT01635101 ↗

registry analysis (other test); High Dose Acetaminophen vs Placebo; p = 0.967; LS Mean Difference 1.4 (97.5% CI -75.9 to 78.7); ANOVA NCT01635101 ↗

Publications

• Hammer GB, Maxwell LG, Taicher BM, Visoiu M, Cooper DS, Szmuk P, Pheng LH, Gosselin NH, Lu J, Devarakonda K. Randomized Population Pharmacokinetic Analysis and Safety of Intravenous Acetaminophen for Acute Postoperative Pain in Neonates and Infants. J Clin Pharmacol. 2020 Jan;60(1):16-27. doi: 10.1002/jcph.1508. Epub 2019 Aug 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Acetaminophen	Small molecule	12.5 mg/kg	Intravenous
Subject	Acetaminophen	Small molecule	15 mg/kg	Intravenous

Indications

No indication recorded.