Dexmedetomidine vs Fentanyl for BMT (DexBMT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00654329
Recruitment Status : Completed
First Posted : April 8, 2008
Results First Posted : April 25, 2011
Last Update Posted : April 25, 2011
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by:
Children's Research Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Otitis Drug: Saline Drug: Fentanyl Drug: Dexmedetomidine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Dexmedetomidine for Peri-operative Sedation and Analgesia in Children Undergoing Bilateral Myringotomy With Tube Placement (BMT)
Study Start Date : August 2005
Primary Completion Date : December 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Dexmedetomidine 1microgram/kilogram
Dexmedetomidine 1microgram/kilogram intranasal
Drug: Dexmedetomidine
Dexmedetomidine, transmucosal, 1 microgram/kilogram
Other Name: Precedex
Experimental: Dexmedetomidine 2 micrograms/kilogram
Dexmedetomidine 2 micrograms/kilogram intranasal
Drug: Dexmedetomidine
Dexmedetomidine, 2 microgram/kilogram, transmucosal route
Other Name: Precedex
Active Comparator: Fentanyl 2 micrograms/kilogram
Fentanyl 2 micrograms/kilogram intranasal
Drug: Fentanyl
Fentanyl, nasal transmucosal, 2 micrograms/kilogram
Other Name: Actiq, Fentora
Placebo Comparator: Normal saline placebo
Normal saline placebo intranasal
Drug: Saline
Normal saline, given intranasally
Other Name: Normal Saline

Primary Outcome Measures :
  1. Incidence of Pain [ Time Frame: up to 24 hours ]
    Pain greater than a zero reported in the Post Anesthesia Care Unit (PACU)

Secondary Outcome Measures :
  1. Length of Stay in PACU [ Time Frame: up to 24 hours ]
    Total time from PACU entry until discharge

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Subjects must meet all of the following inclusion criteria to be eligible for participation:

    1. The subject is 6 months to 6 years of age
    2. The subject's American Society of Anesthesiologists (ASA) physical status is ASA 1 or 2 (see appendix 1)
    3. The subject is scheduled for elective bilateral myringotomy with tube placement
    4. The subject's parent/legally authorized guardian has given written informed consent to participate

      Exclusion Criteria:

  • Subjects will be excluded from study participation if any of the following exclusion criteria exists:

    1. The subject has a history or a family (parent or sibling) history of malignant hyperthermia
    2. The subject has known significant renal or hepatic disorders determined by medical history, physical examination or laboratory tests
    3. The subject has a known or suspected allergy to opioid analgesics or dexmedetomidine
    4. The subject has history of. cardiovascular issues which would preclude the use of dexmedetomidine, (e.g. Down's Syndrome, dysrhythmias, conditions where hypotension is to be avoided)
    5. The subject has know central nervous system disease or neurological impairment
    6. The subject is an ASA classification of 3 or greater (See Appendix 1)
    7. The subject has a medical condition requiring an intravenous induction (i.e. severe uncontrolled gastro-esophageal reflux)
    8. The subject refuses inhalation induction
    9. The subject is scheduled for a surgical sub-procedure (i.e. adenoidectomy, tonsillectomy)

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 identifier (NCT number): NCT00654329

United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Children's Research Institute
Hospira, now a wholly owned subsidiary of Pfizer
Principal Investigator: Julia C Finkel, MD Children's Research Institute

Responsible Party: Julia C. Finkel, MD, Children's National Medical Center Identifier: NCT00654329     History of Changes
Other Study ID Numbers: 3641
Agreement # 10698
First Posted: April 8, 2008    Key Record Dates
Results First Posted: April 25, 2011
Last Update Posted: April 25, 2011
Last Verified: March 2011

Keywords provided by Children's Research Institute:
Dexmedetomidine, transmucosal, myringotomy,

Additional relevant MeSH terms:
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
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
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General