Dexmedetomidine vs Fentanyl for BMT (DexBMT)

This study has been completed.
Sponsor:
Collaborator:
Hospira, Inc.
Information provided by:
Children's Research Institute
ClinicalTrials.gov Identifier:
NCT00654329
First received: April 3, 2008
Last updated: March 28, 2011
Last verified: March 2011
  Purpose

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 Intervention Phase
Otitis
Drug: Saline
Drug: Fentanyl
Drug: Dexmedetomidine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Dexmedetomidine for Peri-operative Sedation and Analgesia in Children Undergoing Bilateral Myringotomy With Tube Placement (BMT)

Resource links provided by NLM:


Further study details as provided by Children's Research Institute:

Primary Outcome Measures:
  • Incidence of Pain [ Time Frame: up to 24 hours ] [ Designated as safety issue: No ]
    Pain greater than a zero reported in the Post Anesthesia Care Unit (PACU)


Secondary Outcome Measures:
  • Length of Stay in PACU [ Time Frame: up to 24 hours ] [ Designated as safety issue: No ]
    Total time from PACU entry until discharge


Enrollment: 101
Study Start Date: August 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   6 Months to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  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: NCT00654329

Locations
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, Inc.
Investigators
Principal Investigator: Julia C Finkel, MD Children's Research Institute
  More Information

No publications provided

Responsible Party: Julia C. Finkel, MD, Children's National Medical Center
ClinicalTrials.gov Identifier: NCT00654329     History of Changes
Other Study ID Numbers: 3641, Agreement # 10698
Study First Received: April 3, 2008
Results First Received: February 23, 2011
Last Updated: March 28, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Otitis
Ear Diseases
Otorhinolaryngologic Diseases
Fentanyl
Dexmedetomidine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
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 August 28, 2014