IV Acetaminophen in Children Undergoing Palatoplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01760330
Recruitment Status : Withdrawn (Unable to obtain funding)
First Posted : January 4, 2013
Last Update Posted : March 8, 2016
Information provided by (Responsible Party):
Tarun Bhalla, MD, Nationwide Children's Hospital

December 12, 2012
January 4, 2013
March 8, 2016
December 2015
December 2016   (Final data collection date for primary outcome measure)
Pain [ Time Frame: 24 hrs. post-op. ]
Pain scores will be assessed.
Same as current
Complete list of historical versions of study NCT01760330 on Archive Site
Opioid consumption [ Time Frame: 24 hrs. post-op ]
Same as current
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IV Acetaminophen in Children Undergoing Palatoplasty
A Prospective, Double-Blinded, Randomized Comparison of Intravenous Acetaminophen Versus Placebo 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.
Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cleft Palate
  • Drug: IV acetaminophen
    Other Name: Ofirmev
  • Drug: Placebo
  • Active Comparator: IV acetaminophen
    IV acetaminophen administered q 4 hrs. for a total of 24 hrs.
    Intervention: Drug: IV acetaminophen
  • Placebo Comparator: Placebo
    Normal saline administered IV every 4 hrs. for a total of 24 hrs.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2016
December 2016   (Final data collection date for primary outcome measure)

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.)
Sexes Eligible for Study: All
Child, Adult, Older Adult
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Tarun Bhalla, MD, Nationwide Children's Hospital
Nationwide Children's Hospital
Not Provided
Not Provided
Nationwide Children's Hospital
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP