IV Acetaminophen in Children Undergoing Palatoplasty

Phase 2

Withdrawn

• Conditions: Cleft Palate
• Interventions: Drug: IV acetaminophen; Drug: Placebo

• Registration Number: NCT01760330
• Lead Sponsor: Nationwide Children's Hospital

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 Description

Not available

Study Timeline

• Study First Submitted: 2012-12-12
• Study First Submitted QC: 2013-01-03
• Study First Posted: 2013-01-04
• Study Start: 2015-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-04
• Last Update Posted: 2016-03-08
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• ASA physical status I or II
• Presenting for repair of palatoplasty with Drs. Kirschner or Pearson

Exclusion Criteria

• ASA physical status > II
• Underlying Syndrome
• Significant co-morbid diseases (cardiac, pulmonary, neurological disease)
• Patients having concomitant procedures (tonsillectomy, adenoidectomy, etc.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV acetaminophen	IV acetaminophen	IV acetaminophen administered q 4 hrs. for a total of 24 hrs.
Placebo	Placebo	Normal saline administered IV every 4 hrs. for a total of 24 hrs.

Primary Outcome Measures

Name	Time	Method
Pain	24 hrs. post-op.	Pain scores will be assessed.

Secondary Outcome Measures

Name	Time	Method
Opioid consumption	24 hrs. post-op

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States