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Dexmedetomidine Versus Fentanyl Following Pressure Equalization Tube Placement

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ClinicalTrials.gov Identifier: NCT01188551
Recruitment Status : Completed
First Posted : August 25, 2010
Results First Posted : April 1, 2014
Last Update Posted : April 1, 2014
Sponsor:
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Otitis Media Drug: Dexmedetomidine Drug: Fentanyl Drug: Midazolam Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pain Management Following Myringotomy and Tube Placement: Intranasal Dexmedetomidine Versus Fentanyl
Study Start Date : January 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. FLACC Behavioral Pain Assessment Scale Scores [ Time Frame: 30 mins. post-op ]

    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 :
  1. Recovery From General Anesthesia [ Time Frame: 30 mins. post-op ]
    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.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01188551


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

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
First Posted: August 25, 2010    Key Record Dates
Results First Posted: April 1, 2014
Last Update Posted: April 1, 2014
Last Verified: February 2014

Keywords provided by Joseph D. Tobias, Nationwide Children's Hospital:
myringotomy
pressure equalization tubes

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