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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: February 17, 2014
Last verified: February 2014
  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
Drug: Midazolam
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pain Management Following Myringotomy and Tube Placement: Intranasal Dexmedetomidine Versus Fentanyl

Resource links provided by NLM:


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

Primary Outcome Measures:
  • FLACC Behavioral Pain Assessment Scale Scores [ Time Frame: 30 mins. post-op ] [ Designated as safety issue: No ]

    FLACC Behavioral Pain Assessment Scale: each of the five categories (F) Face, (L) Legs, (A) Activity, (C) Cry, (C) Consolability is scored from 0-2, which results in a total score between 0 and 10.

    0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort or pain or both



Secondary Outcome Measures:
  • Recovery From General Anesthesia [ Time Frame: 30 mins. post-op ] [ Designated as safety issue: No ]
    Post-anesthesia recovery score: Aldrete The Aldrete scoring system takes into account the patient's ability to move, respiration, circulation, consciousness, and oxygen saturation. A maximum of two points are awarded in each category and a score of 9 or 10 is required for discharge.


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 w/ midazolam
Midazolam 0.5 mg/kg given orally pre-op and 1 dose of dexmedetomidine 1mcg/kg given intranasally in OR.
Drug: Dexmedetomidine
dexmedetomidine (1 µg/kg) will be administered intranasally
Other Name: Precedex
Drug: Midazolam
Sedative given pre-op.
Other Name: Versed
Active Comparator: fentanyl w/ midazolam
Midazolam 0.5 mg/kg given orally pre-op and 1 dose of fentanyl 2mcg/kg given intranasally in OR.
Drug: Fentanyl
fentanyl (2 µg/kg) will be administered intranasally
Drug: Midazolam
Sedative given pre-op.
Other Name: Versed
Experimental: dexmedetomidine w/o midazolam
1 dose of dexmedetomidine 1mcg/kg given intranasally in OR without any pre-medication.
Drug: Dexmedetomidine
dexmedetomidine (1 µg/kg) will be administered intranasally
Other Name: Precedex
Active Comparator: fentanyl w/o midazolam
1 dose of fentanyl 2mcg/kg given intranasally in the OR without any pre-medication.
Drug: Fentanyl
fentanyl (2 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: June 26, 2013
Last Updated: February 17, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 25, 2014