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Completed Phase 1 Interventional Results available

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

ClinicalTrials.gov ID: NCT00493246

Public ClinicalTrials.gov record NCT00493246. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 5, 2026, 12:59 AM EST

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Official title

A Prospective, Multi-Center, Randomized, Open-Label, Single and Repeated Dose, 48 Hour Study, of Intravenous Acetaminophen in Pediatric Inpatients to Determine Pharmacokinetics (PK) and Safety in Acute Pain and Fever

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00493246
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Mallinckrodt
Industry
Enrollment
75 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
29 Days to 16 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 2007 (Type not available)
Primary completion
Nov 2008 (Actual)
Completion
Nov 2008 (Actual)
Last update posted
Oct 21, 2016

2007 – 2008

United States locations

U.S. sites
5
U.S. states
4
U.S. cities
5
Facility City State ZIP Site status
Lucile Packard Children's Hospital Stanford California 94305 —
CS Mott Childrens Hospital Ann Arbor Michigan 48109 —
Duke University Health Systems Durham North Carolina 27710 —
Children's Hospital Of Philadelphia Philadelphia Pennsylvania 19104 —
Children's Hospital Of Pittsburgh Pittsburgh Pennsylvania 15213 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00493246, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 21, 2016 · Synced Nov 5, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00493246 live on ClinicalTrials.gov.

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