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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Placebo Controlled, Multi-Center Study of the Efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) of IV Acetaminophen for the Treatment of Acute Pain i

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.

Detailed Summary:
Sponsor: Mallinckrodt

Current Primary Outcome: Total rescue opioid consumption [ Time Frame: T0-T24; A total opioid consumption will be obtained from T0-T24. Total rescue opioid consumption will be collected during the 24 hours while the subject is on study medication. ]

Total rescue opioid consumption from T0 to T24 (total milligrams (mg) per kilogram (kg) IV morphine equivalent), comparing each IV Acetaminophen Group to the combined Control Groups


Original Primary Outcome: Total rescue opioid consumption [ Time Frame: T0-T24; A total opiod consumption will be obtained from T0-T24. Total rescue opioid consumption will be collected during the 24 hours while the subject is on study medication. ]

Total rescue opioid consumption from T0 to T24 (total milligrams (mg) per kilogram (kg) IV morphine equivalent), comparing each IV Acetaminophen Group to the combined Control Groups


Current Secondary Outcome:

  • Correlation between efficacy concentration and rescue medication consumption. [ Time Frame: T0 to T12 FLAAC or LNPS will be assessed at T0, T0.05, T1, T2, T3, T4, T6, T12, T18, T24 and prior to each dose of rescue medication ]
    Correlation between efficacy concentration Ceff and total opioid rescue medication consumption (in IV morphine equianalgesic dose equivalents) from T0 to T12 comparing each IV Acetaminophen Group to the combined Control Groups. The correlation will be measured by the mean slope of the linear regression comparing acetaminophen exposure area under the curve (AUC) in the effect compartment and total milligrams (mg)/kilogram (kg) IV morphine equivalent doses from T0 to T12.
  • Subjects with clinically meaningful changes in laboratory parameters [ Time Frame: T0-T24 Baseline labs as compared to End of Study Labs. Subject will be followed for an average of 24 hours while hospitalized. ]
    The percentage of subjects with clinically meaningful changes in laboratory parameters will be summarized by treatment group


Original Secondary Outcome: Same as current

Information By: Mallinckrodt

Dates:
Date Received: June 29, 2012
Date Started: June 2012
Date Completion:
Last Updated: August 9, 2016
Last Verified: August 2016