IV Acetaminophen in Children Undergoing Palatoplasty

Cleft Palate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01760330
• Other study ID #: IRB12-00709
• Status: Withdrawn
• Phase: Phase 2
• First received: December 12, 2012
• Last updated: March 4, 2016
• Start date: December 2015
• Est. completion date: December 2016

Study information

• Verified date: March 2016
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cleft Palate

Intervention

Drug:
• IV acetaminophen

• Placebo

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Pain scores will be assessed.	24 hrs. post-op.	No
Secondary	Opioid consumption		24 hrs. post-op	No