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Dexmedetomidine vs Placebo for Pediatric Cleft Palate Repair

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: NCT02915042
Recruitment Status : Withdrawn (Recruitment concerns)
First Posted : September 26, 2016
Last Update Posted : February 5, 2019
Information provided by (Responsible Party):
Chris Glover, Baylor College of Medicine

Brief Summary:
The primary objective of this study is to evaluate the efficacy of administering intravenous dexmedetomidine as a single preemptive dose to placebo in reducing the total 24 hour dose of opioids as measured on a weight adjusted morphine equivalent basis.

Condition or disease Intervention/treatment Phase
Cleft Palate Drug: Dexmedetomidine Drug: Placebo Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blinded, Placebo Controlled Trial Using Single Dose Dexmedetomidine In The Treatment Of Pain In Patients Undergoing Cleft Palate Repair
Estimated Study Start Date : December 31, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Experimental group
Intervention group 1: pre-operative administration of IV dexmedetomidine 1mcg/kg
Drug: Dexmedetomidine
Analgesic Efficacy
Other Name: Precedex

Placebo Comparator: Placebo group
Intervention group 2: placebo
Drug: Placebo
Saline placebo
Other Name: Saline

Primary Outcome Measures :
  1. Postoperative pain control [ Time Frame: 24 hours ]
    Assessment of and clinical measurement that one treatment group will be better with postoperative pain management than the non-treatment group, which would be similar to published data for children undergoing this procedure. This will be measured in a mean pain score. There will be integrating of pain scores and morphine consumption.

  2. Opioid consumption [ Time Frame: 24 hours ]
    Opioid consumption is measured in mean morphine equivalent dose in mcg/kg, this will be integrated with the pain scores.

Secondary Outcome Measures :
  1. The number of children with FLACC scores greater than 4 [ Time Frame: 24 hours ]
    FLACC Pain Scores

  2. Time to first rescue analgesia [ Time Frame: 24 hours ]
    Time in minutes to administration of first dose of rescue analgesia

  3. Respiratory depression [ Time Frame: 24 hours ]
    Patients with SPO2 less than 85%

  4. Postoperative vomiting [ Time Frame: 24 hours ]
    postoperative emesis

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Patients between 6mo to 8 years of age scheduled to undergo primary or secondary cleft repair.

Exclusion Criteria:

  • Patients with significant cognitive impairment
  • Patients with various syndromes known to be associated with difficult airways(e.g. Goldenhar's syndrome, Treacher- Collins, Trisomy 13 or 18, Pierre Robin, etc.)
  • Have a prior history of allergy, hypersensitivity or contraindication to any drug used for anesthesia including opioids (morphine, fentanyl, hydrocodone) and inhalation agents(i.e. children with susceptibility to malignant hyperthermia)
  • Have a history of congenital bleeding diathesis(e.g. hemophilia) or any active clinically significant bleeding, impaired renal or hepatic function
  • Children with heart failure, heart block, ventricular dysfunction, cardiomyopathy, myocarditis or congenital heart disease where cardiac output is rate dependent and relies on A-V synchrony (e.g. single ventricle). Children with well controlled atrial or ventricular septal defects, patent ductus arteriosus, repaired coarctation of the aorta will qualify if they have no cardiac rhythm or hypertension problems.
  • Children with uncontrolled hypertension, intracranial vascular malformations, Moya Moya disease or intracranial hypertension.
  • Any child who has received an investigational drugs within 30 days before study drug administration.
  • Inability of the parent or legal guardian to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board) and agree to abide by the study restrictions.
  • Be otherwise unsuitable for the study, in the opinion of the Investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02915042

Sponsors and Collaborators
Baylor College of Medicine
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Principal Investigator: Chris D. Glover, MD Baylor College of Medicine/Texas Children's Hospital

Additional Information:

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Responsible Party: Chris Glover, Dr. Chris Darrel Glover Assistant Professor Anesthesiology Texas Children's Hospital Baylor College of Medicine, Baylor College of Medicine Identifier: NCT02915042     History of Changes
Other Study ID Numbers: H-34431
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chris Glover, Baylor College of Medicine:
Additional relevant MeSH terms:
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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
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action