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Dexmedetomidine for Peri-Operative Sedation and Analgesia in Children Undergoing Bilateral Myringotomy With Tube Placement (BMT) (DexBMT)
This study has been completed.
First Received: April 3, 2008   Last Updated: January 29, 2009   History of Changes
Sponsors and Collaborators: Children's Research Institute
Hospira, Inc.
Information provided by: Children's Research Institute
ClinicalTrials.gov Identifier: NCT00654329
  Purpose

Relative to placebo or fentanyl,

  1. Dexmedetomidine, at doses of 1 microgram/kilogram or 2 micrograms/kilogram, will provide superior postoperative sedation as measured by post-operative agitation, pain scores and reduced need for rescue analgesia.
  2. Dexmedetomidine, at doses of 1 microgram/kilogram or 2 microgram/kilogram, will produce a more favorable time to emergence and readiness for discharge from Recovery Phase I and Phase II.
  3. There will be no clinically significant difference in hemodynamic measures including heart rate and blood pressure, among the four treatment groups either intraoperatively, or during the recovery period (Recovery Phase I and Phase II).

Condition Intervention Phase
To Perform a Dose Ranging Study of Nasal Transmucosal Dexmedetomidine
Drug: Saline
Drug: Fentanyl
Drug: Dexmedetomidine
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:
  • Primary outcomes will focus on quality of emergence, recovery and postoperative analgesia in pediatric subjects ages 6 months to 6 years undergoing bilateral myringotomy with tube placement (BMT) as compared to nasal transmucosal fentanyl. [ Time Frame: Perioperative ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary outcomes will focus on hemodynamic impact, both intraoperatively and during the recovery period. [ Time Frame: Perioperative ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 160
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
1: Placebo Comparator Drug: Saline
Normal saline, given intranasally
2: Active Comparator Drug: Fentanyl
Fentanyl, nasal transmucosal, 2mcg/kg
3: Experimental Drug: Dexmedetomidine
Dexmedetomidine, transmucosal, 1mcg/kg
4: Experimental Drug: Dexmedetomidine
Dexmedetomidine, 2mcg/kg, transmucosal route

  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 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
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: Children's National Medical Center ( Julia C. Finkel, MD )
Study ID Numbers: 3641, Agreement # 10698
Study First Received: April 3, 2008
Last Updated: January 29, 2009
ClinicalTrials.gov Identifier: NCT00654329     History of Changes
Health Authority: United States: Institutional Review Board

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

Study placed in the following topic categories:
Anesthetics, Intravenous
Neurotransmitter Agents
Fentanyl
Adrenergic alpha-Agonists
Adrenergic Agents
Adjuvants, Immunologic
Anesthetics
Central Nervous System Depressants
Narcotics
Adrenergic Agonists
Anesthetics, General
Analgesics, Non-Narcotic
Hypnotics and Sedatives
Dexmedetomidine
Analgesics
Peripheral Nervous System Agents
Analgesics, Opioid

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

ClinicalTrials.gov processed this record on September 09, 2009