Intravenous Use of Acetaminophen, 7-Day Study

Study of the Safety and Efficacy of Intravenous Acetaminophen in Pediatric Inpatients

Protocol Description

The goal of this Phase III, multi-center study is to better understand how well acetaminophen works at a particular dosage level when given intravenously. For treatment of pain or fever, doctors frequently use acetaminophen, the active ingredient in Tylenol®. Acetaminophen, given by pill or suppository, is well understood. This study will help to understand the effectiveness and potential side effects of acetaminophen when given intravenously to children.

Eligibility Criteria

Inpatients of both genders, from newborns to age 17, requiring acetaminophen for treatment of pain or fever may participate in this study.
Boys: Newborns up to age 17
Girls: Newborns up to age 17

Requirements

Participants will be given acetaminophen intravenously on a schedule and with a dosage based on body weight over 5 to 7 days while in the hospital. A follow-up visit will be conducted 7 days after the last day the child receives intravenous acetaminophen. The clinic will make a follow-up phone call to check on the child’s health 30 days later.
Visits: 1 beyond inpatient period
Duration: About 1 month

Status: Open for Enrollment

Source(s) of Support

Cadence Pharmaceuticals, Inc.

Primary Investigator

Ayse Fidan Genc, MD

Contact Information

To get started, please contact:
Kathleen Fertal, RN, BSN, CCRC
412-692-5260