Dexmedetomidine vs Placebo for Pediatric Cleft Palate Repair

• Status: Withdrawn
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Baylor College of Medicine
• Treatments: Dexmedetomidine

Criteria

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.