Overview

Safety and Pharmacokinetic (PK) Study of Intravenous (IV) Acetaminophen Administration in Pediatric Inpatients

Status:
Completed
Trial end date:
2008-11-01
Target enrollment:
0
Participant gender:
All
Summary
We are doing this study to find out what happens to acetaminophen in the body after it is given to children through the vein. Children's bodies may handle drugs differently than adults. Understanding how long the drug stays in the body and how the drug is changed or metabolized by the body (called pharmacokinetics) is an important step in learning what the best dose of acetaminophen for children should be. We are also interested in learning about the safety of this medication when given to children.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mallinckrodt
Treatments:
Acetaminophen
Criteria
To be eligible for entry into the Study, Subjects must meet or Subjects' Parent or Guardian
must meet, agree with or confirm all of the following criteria:

1. Provide written Informed Consent/Assent prior to participation in the Study

2. Age strata:

- Full-term Neonates (≤ 28 days old and minimum post conception age of 37 weeks at
birth)

- Infants [29 days to <2 years (yrs) old]

- 29 days to <6 months

- 6 to <12 months

- 12 to <24 months)

- Children (2 yrs to <12 yrs old)

- Adolescents (12 yrs to ≤16 yrs old)

3. Inpatient status: are currently inpatients or have an admission scheduled and will
soon become an inpatient (e.g., elective surgery)

4. Diagnosis: requires or will require analgesic treatment for acute pain or antipyretic
treatment for fever

5. IV access: have a need for IV access for the duration of the Study either due to a
nothing by mouth (NPO) status or due to the Investigator's assessment that oral
treatment is not optimal (for example, severe nausea or vomiting)

6. The Subject's Parent/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

7. Be free of other physical, mental, or medical conditions which, in the opinion of the
Investigator after completing the screening assessment, make Study participation
inadvisable

8. If a female of child bearing potential, have a negative pregnancy test

Exclusion Criteria (Screening)

A Subject is NOT eligible for entry if ANY of the following criteria are met:

1. Is not able to comply with the plasma sampling requirements of the Study

2. Has known or suspected hypersensitivity to acetaminophen or the inactive excipients of
IV Acetaminophen.

3. Has been taking any acetaminophen-containing product in the 12 hours prior or any of
the following in the 48 hours prior to randomization in the Study: probenecid,
disulfiram, isoniazide, St. John's wort, skullcap, chaparral, comfrey, germander, jin
bu huan, kava, pennyroyal, and valerian

4. Has any significant medical condition that in the opinion of the Investigator
contraindicates participation in the Study

5. Has impaired liver function, with evidence of clinically significant liver disease, or
other condition that may suggest the potential for an increased susceptibility to
hepatic toxicity with IV APAP exposure. For this criterion, a total bilirubin greater
than 1.5 times upper limit of normal (ULN) for age or an Alanine aminotransferase
(ALT) serum glutamic pyruvic transaminase (SGPT) or Aspartate transaminase (AST) serum
glutamic oxaloacetic transaminase (SGOT) greater than 2.5 times ULN for age will be
deemed as evidence of clinically significant (Common Terminology Criteria for Adverse
Events [CTCAE] Grade 2) liver dysfunction or disease.

6. Has significantly impaired renal function or known significant renal disease, as
evidenced by an estimated glomerular filtration rate (using the Schwartz formula)
calculated to be less than 1/3rd of normal for the applicable age strata

7. Has participated in another interventional clinical Study (investigational or marketed
product) within 30 days of the planned Study randomization date