NCT01760330

IV Acetaminophen in Children Undergoing Palatoplasty

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Nationwide Children's Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Cleft Palate

Interventions

Type	Name	Description
DRUG	IV acetaminophen
DRUG	Placebo

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2013-01-04
• Last updated: 2016-03-08

Locations

1 site across 1 country: United States