Dexmedetomidine vs Placebo for Pediatric Cleft Palate Repair

NCT02915042 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2019-02-05

No results posted yet for this study

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.

Conditions

  • Cleft Palate

Interventions

DRUG

Dexmedetomidine

Analgesic Efficacy

DRUG

Placebo

Saline placebo

Sponsors & Collaborators

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Chris D. Glover, MD · Baylor College of Medicine - Texas Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-31
Primary Completion
2019-12-31
Completion
2019-12-31

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02915042 on ClinicalTrials.gov