Dexmedetomidine vs Fentanyl for BMT

NCT00654329 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2011-04-25

Study results available
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Summary

A randomized controlled clinical trial to examine effects of intranasal dexmedetomidine, an α2-adrenorecptor agonist, on pain control and agitation in children undergoing BMT.

Conditions

  • Otitis

Interventions

DRUG

Saline

Normal saline, given intranasally

DRUG

Fentanyl

Fentanyl, nasal transmucosal, 2 micrograms/kilogram

DRUG

Dexmedetomidine

Dexmedetomidine, transmucosal, 1 microgram/kilogram

DRUG

Dexmedetomidine

Dexmedetomidine, 2 microgram/kilogram, transmucosal route

Sponsors & Collaborators

  • Hospira, now a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY
  • Children's National Research Institute

    lead OTHER

Principal Investigators

  • Julia C Finkel, MD · Children's National Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States

Study Locations

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Entities

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 NCT00654329 on ClinicalTrials.gov