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

Mallinckrodt22 sites in 1 country197 target enrollmentJune 2012

ConditionsAcute Pain

InterventionsIV Acetaminophen IV Control

DrugsIV Control IV Acetaminophen

Overview

Phase: Phase 3
Intervention: IV Acetaminophen
Conditions: Acute Pain
Sponsor: Mallinckrodt
Enrollment: 197
Locations: 22
Primary Endpoint: Total Rescue Opioid Consumption
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 2012

End Date

November 2015

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Mallinckrodt

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject is ≥ 28 weeks gestational age and \< 2 years old at study enrollment
•Subject will undergo surgery or had a traumatic injury expected to produce moderate to severe pain and patient is expected to require analgesic treatment for acute pain for 24 hours
•Subject has a medically reasonable need for IV treatment due to their underlying procedure(s) or medical condition(s) for the duration of the study
•Subject has reliable vascular access for administration of study medication and PK sampling
•Subject has a bodyweight which, in the opinion of the Investigator does not preclude participation in the study.
•Subject is free of other physical, mental, or medical conditions which, in the opinion of the Investigator, make study participation inadvisable or make it impossible to accurately assess efficacy or safety endpoints
•Subject's parent or guardian must provide written informed consent prior to participation in the study
•Subject's parent or guardian must have the ability to read and understand the study procedures and have the ability to communicate meaningfully with the study investigator and staff

Exclusion Criteria

•Subject is not able to comply with the sampling requirements of the study
•Subject has known or suspected hypersensitivity to acetaminophen or the excipients of IV acetaminophen
•Subject has any significant medical condition that in the opinion of the Investigator contraindicates participation in the study or impairs the assessment of efficacy or safety
•Subject has participated in another interventional clinical study within 30 days of the planned study randomization date
•Pre-Randomization (Qualification) Inclusion Criteria
•Subject has not been administered any of the following:
•any acetaminophen-containing product, nonsteroidal anti-inflammatory agent, central alpha-adrenergic agents (e.g., clonidine, dexmedetomidine) or ketamine within 6 hours of baseline (T0)
•received a regional or neuraxial (caudal, epidural or spinal) anesthetic with local anesthetics within 6 hours of T0
•Subject does not have abnormal liver function tests from a sample obtained post-operatively/post-trauma and prior to randomization above protocol-specified limits
•Subject does not have significantly impaired renal function or known significant renal disease which in the opinion of the Investigator would contraindicate study participation.

Arms & Interventions

Low Dose Acetaminophen

Participants receive a low dose of acetaminophen intravenously (IV) for 24 hours

Intervention: IV Acetaminophen

High Dose Acetaminophen

Participants receive a low dose of acetaminophen (IV) for 24 hours

Intervention: IV Acetaminophen

Placebo

Participants receive matching placebo (IV) for 24 hours

Intervention: IV Control

Outcomes

Primary Outcomes

Total Rescue Opioid Consumption

Time Frame: in 24 hours

Total micrograms per kilogram (µg/kg) of rescue opioid used during the same 24 hours the subject is on study medication

Secondary Outcomes

Summary of Pain Intensity Using the LNPS in Younger Infants(within 24 hours)
Pain Intensity Using the FLACC Score in Older Infants(within 24 hours)
Time to First Rescue Medication(within 24 hours)
Summary of Pain Intensity Using the Leuven Neonatal Pain Scale (LNPS) in Neonates(within 24 Hours)
Pain Intensity Using the FLACC Score in Intermediate Aged Infants(within 24 hours)