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Dexmedetomidine Versus Fentanyl Following Pressure Equalization Tube Placement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01188551
First received: August 24, 2010
Last updated: May 1, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Otitis Media
 Drug: Dexmedetomidine
Drug: Fentanyl
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pain Management Following Myringotomy and Tube Placement: Intranasal Dexmedetomidine Versus Fentanyl

Resource links provided by NLM:

MedlinePlus related topics: Ear Infections
U.S. FDA Resources

Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • Pain [ Time Frame: 60 mins. post-op ] [ Designated as safety issue: No ]
    FLACC Behavioral Pain Assessment Scale, Objective Pain Scale (OPS) of Hanallah et al for Postoperative Pain Assesment


Secondary Outcome Measures:
  • Recovery characteristics from general anesthesia [ Time Frame: 60 mins. post-op ] [ Designated as safety issue: No ]
    Post-anesthesia recovery score: Aldrete and Steward


Enrollment: 100
Study Start Date: January 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dexmedetomidine Drug: Dexmedetomidine
dexmedetomidine (1 µg/kg) will be administered intranasally
Other Name: Precedex
Active Comparator: fentanyl Drug: Fentanyl
fentanyl (1 µg/kg) will be administered intranasally

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • functional status as assigned by the American Society of Anesthesiology (ASA) classification of I or II (no or minimal co-morbid disease)
  • patients scheduled for placement of bilateral myringotomy tubes

Exclusion Criteria:

  • history of allergy to either dexmedetomidine or fentanyl
  • concomitant use of medications which may exaggerate the HR response of dexmedetomidine including digoxin or β-adrenergic antagonists.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01188551

Locations
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
  More Information

Publications:

Responsible Party: Joseph D. Tobias, Chairman Dept. of Anesthesiology & Pain Medicine, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01188551     History of Changes
Other Study ID Numbers: IRB10-00377
Study First Received: August 24, 2010
Last Updated: May 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Nationwide Children's Hospital:
myringotomy
pressure equalization tubes

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Fentanyl
Dexmedetomidine
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013