IV Acetaminophen in Children Undergoing Palatoplasty
- 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
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- ASA physical status I or II
- Presenting for repair of palatoplasty with Drs. Kirschner or Pearson
- 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