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

Study ID
STU 042012-027

Cancer Related

Healthy Volunteers

Study Sites

  • Children’s Medical Center (Dallas, Plano, Southlake)

Roxana Ploski

Principal Investigator
Peter Szmuk


This is a prospective, multicenter, double-blind, placebo-controlled study of pediatric subjects
less than age 2 years with acute pain requiring multiple doses of analgesics where there is a
medically reasonable need for iV medication due to a surgical procedure or underlying medical
condition. eligible subjects will be enrolled and randomized to receive either iV acetaminophen
plus standard of care on demand rescue opioids [SoC] (iV acetaminophen Groups) or saline
placebo plus SoC (Control Groups).
Total opioid consumption over a 6-hour pre-randomization qualification period will be used to
characterize a subject's consumption as either [Quote]lower[Quote] or [Quote]higher[Quote] based upon a threshold
average of 30 ug/kg/h iV morphine equivalent (a total of 210 ug/kg over the 6 hour period).
approximately 150 subjects will be enrolled and randomized into the study in order to obtain a
total of 144 treated and [Quote]efficacy[Quote] evaluable subjects (96 iV acetaminophen Group a and B and
48 Control Group C and D). efficacy evaluable subjects include all randomized subjects who
received at least one completed dose of study medication and had at least one pain assessment
after T0.
eligible patients will be stratified according to 4 dose regimen age categories (extreme preterm
neonates, preterm neonates, full-term neonates and all infants) and 2 opioid consumption
categories (lower and higher), and randomized to either the iV acetaminophen or Control
Groups. eligible subjects will be randomly assigned to one of two iV acetaminophen Groups
(a [target n [?] 48] or B [target n [?] 48]) or two matched Control Groups (C [target n [?] 24] or
D [target n [?] 24]) who will receive a normal saline placebo in the same volume as the
iV acetaminophen Group. The treatment groups will be assigned in a
2:2:1:1 ratio: acetaminophen Group a; acetaminophen Group B; Control Group C; Control
Group D; respectively.

Participant Eligibility

1. Subject is >= 28 weeks to <= 40 weeks gestational age and < 2 years old at study

2. Subject will undergo surgery or had a traumatic injury expected to produce moderate to
severe pain and patient is expected to require analgesia for acute pain for 24 hours

3. Subject has a medically reasonable need and expectation for IV treatment due to their
underlying procedure(s) or medical condition(s) for the duration of the study

4. Subject has a bodyweight which, in the opinion of the Investigator does not preclude
participation in the study.

5. Subject has reliable vascular access for administration of study medication and PK

6. 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

7. Subject[Single Quote]s parent or guardian must provide written informed consent prior to participation
in the study

8. Subject[Single Quote]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