Clinical Trial: IV Acetaminophen in Children Undergoing Palatoplasty

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: A Prospective, Double-Blinded, Randomized Comparison of Intravenous Acetaminophen Versus Placebo in Children Undergoing Palatoplasty

Brief Summary: This project is being used to assess the utility of intravenous acetaminophen in the pediatric population undergoing palate repairs. This study is a prospective randomized double blinded placebo controlled study. The investigators will have two arms, one group of patients will receive intravenous acetaminophen and one group that will receive a placebo at a total of four doses over 24 hours. The results of this study may affect the intraoperative anesthetic management as well as post-operative surgical management of this specific patient population. The goal is to determine the benefit of adding a non-opioid analgesic and hypothesizing that it may reduce the amount of narcotic consumption in the post anesthesia care unit as well as during the post-operative stay.

Detailed Summary:
Sponsor: Nationwide Children's Hospital

Current Primary Outcome: Pain [ Time Frame: 24 hrs. post-op. ]

Pain scores will be assessed.


Original Primary Outcome: Same as current

Current Secondary Outcome: Opioid consumption [ Time Frame: 24 hrs. post-op ]

Original Secondary Outcome: Same as current

Information By: Nationwide Children's Hospital

Dates:
Date Received: December 12, 2012
Date Started: December 2015
Date Completion: December 2016
Last Updated: March 4, 2016
Last Verified: March 2016