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IV Acetaminophen in Children Undergoing Palatoplasty

This study is not yet open for participant recruitment.
Verified January 2013 by Nationwide Children's Hospital
Sponsor:
Information provided by (Responsible Party):
Tarun Bhalla, MD, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01760330
First received: December 12, 2012
Last updated: January 3, 2013
Last verified: January 2013
History of Changes
  Purpose

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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 50
Study Start Date: January 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01760330

Contacts
Contact: Julie Rice, BSN 614-355-3142 Julie.Rice@nationwidechildrens.org
Contact: N'Diris Barry, BS 614-355-3467 Ndiris.Barry@nationwidechildrens.org

Locations
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            
Sponsors and Collaborators
Nationwide Children's Hospital
  More Information

No publications provided

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: January 3, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 17, 2013