Conditions: Acute Pain
Keywords: Moderate to severe acute pain following surgery or trauma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 197
Healthy volunteers: no

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 description:

Arms:
arm 1: Participants receive a low dose of acetaminophen intravenously (IV) for 24 hours arm 2: Participants receive a low dose of acetaminophen (IV) for 24 hours arm 3: Participants receive matching placebo (IV) for 24 hours

Interventions: intervention 1: IV Acetaminophen intervention 2: IV Control
Intervention descriptions: intervention 1: IV Acetaminophen given every 6 hours (q6h); 4 doses, in 24 hours intervention 2: IV Control q6h; 4 doses, in 24 hours

Protocol document: