IV Acetaminophen in Children Undergoing Palatoplasty

This study has been withdrawn prior to enrollment.
(Unable to obtain funding)
Information provided by (Responsible Party):
Tarun Bhalla, MD, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
First received: December 12, 2012
Last updated: March 4, 2016
Last verified: March 2016
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.

Condition Intervention Phase
Cleft Palate
Drug: IV acetaminophen
Drug: Placebo
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • Pain [ Time Frame: 24 hrs. post-op. ] [ Designated as safety issue: No ]
    Pain scores will be assessed.

Secondary Outcome Measures:
  • Opioid consumption [ Time Frame: 24 hrs. post-op ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: December 2015
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Placebo


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01760330

United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
  More Information

Responsible Party: Tarun Bhalla, MD, Clinical Assistant Professor, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01760330     History of Changes
Other Study ID Numbers: IRB12-00709 
Study First Received: December 12, 2012
Last Updated: March 4, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Cleft Palate
Congenital Abnormalities
Craniofacial Abnormalities
Jaw Abnormalities
Jaw Diseases
Maxillofacial Abnormalities
Mouth Abnormalities
Mouth Diseases
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Stomatognathic Diseases
Stomatognathic System Abnormalities
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents

ClinicalTrials.gov processed this record on May 23, 2016