IV Acetaminophen in Children Undergoing Palatoplasty
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Prospective, Double-Blinded, Randomized Comparison of Intravenous Acetaminophen Versus Placebo in Children Undergoing Palatoplasty|
- Pain [ Time Frame: 24 hrs. post-op. ] [ Designated as safety issue: No ]Pain scores will be assessed.
- Opioid consumption [ Time Frame: 24 hrs. post-op ] [ Designated as safety issue: No ]
|Study Start Date:||July 2014|
|Estimated Study Completion Date:||November 2016|
|Estimated Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
Active Comparator: IV acetaminophen
IV acetaminophen administered q 4 hrs. for a total of 24 hrs.
Drug: IV acetaminophen
Other Name: Ofirmev
Placebo Comparator: Placebo
Normal saline administered IV every 4 hrs. for a total of 24 hrs.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01760330
|Contact: Julie Rice, BSN||614-355-3142||Julie.Rice@nationwidechildrens.org|
|Contact: N'Diris Barry, BS||614-355-3467||Ndiris.Barry@nationwidechildrens.org|
|United States, Ohio|
|Nationwide Children's Hospital||Not yet recruiting|
|Columbus, Ohio, United States, 43205|
|Principal Investigator: Tarun Bhalla, MD|
|Sub-Investigator: Joseph D Tobias, MD|
|Sub-Investigator: Arlyne Thung, MD|
|Sub-Investigator: Greg Pearson, MD|
|Sub-Investigator: Richard Kirschner, MD|