IV Acetaminophen in Children Undergoing Palatoplasty

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Cleft Palate

In brief

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.

Key facts

Study ID

NCT01760330

Run by

Nationwide Children's Hospital

People needed

0

Starts

2015-12-01

Expected to finish

2016-12-01

Last updated by the study team

2016-03-08

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Nationwide Children's Hospital — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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