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Dexmedetomidine Versus Fentanyl Following Pressure Equalization Tube Placement

NCT01188551 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2014-04-01

Study results available
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Summary

This is a study to compare intranasal dexmedetomidine to intranasal fentanyl following anesthesia induction in patients undergoing myringotomy and placement of pressure equalization (PE) tubes in providing analgesia and smoothing emergence from general anesthesia.

Conditions

  • Chronic Otitis Media

Interventions

DRUG

Dexmedetomidine

dexmedetomidine (1 µg/kg) will be administered intranasally

DRUG

Fentanyl

fentanyl (2 µg/kg) will be administered intranasally

DRUG

Midazolam

Sedative given pre-op.

Sponsors & Collaborators

  • Nationwide Children's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT01188551 on ClinicalTrials.gov