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

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 (for example, neurologic diseases such as hemiplegia, demyelinating disorders,
or neuromuscular paralysis, or requirement for prolonged mechanical ventilation
making it impossible to assess pain scales using the LNPS or the FLACC)

- 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 T0

- received a regional or neuraxial (caudal, epidural or spinal) anesthetic with local
anesthetics within 6 hours of T0

- Subject does not have abnormal LFTs from a sample obtained
post-operatively/post-trauma and prior to randomization above the following limits:

- TBL > 3 times upper limit of normal range for age, OR

- ALT (SGPT) > 3 X ULN, OR

- If neonate, in the absence of intentional anticoagulation, INR > 1.5 X ULN or PT
> 1.5 X ULN

- Subject does not have significantly impaired renal function or known significant
renal diseas which in teh opinion of the Investigator would contraindicate study
participation.

- Subject had a nursing assessment documenting moderate to severe pain (pain intensity
score of at least 4 on the LNPS or FLACC) within 6 hours prior to randomization

- Subject required at least one dose of parenteral opioid medication for pain
management (i.e., not pre-emptive therapy) during the 6-hour pre-randomization
period, and is anticipated to require at least one dose of parenteral opioid
medication during the 24 hour treatment period

- If subject is breast feeding, mother has not been administered any acetamionphen
containing product in the previous 6 hours to T0 and throughout the treament period