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Dexmedetomidine vs Fentanyl for BMT (DexBMT)

Primary Purpose

Otitis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Saline
Fentanyl
Dexmedetomidine
Dexmedetomidine
Sponsored by
Children's National Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Otitis focused on measuring Dexmedetomidine, transmucosal, myringotomy,

Eligibility Criteria

6 Months - 6 Years (Child)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Children's National Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

Dexmedetomidine 1microgram/kilogram

Dexmedetomidine 2 micrograms/kilogram

Fentanyl 2 micrograms/kilogram

Normal saline placebo

Arm Description

Dexmedetomidine 1microgram/kilogram intranasal

Dexmedetomidine 2 micrograms/kilogram intranasal

Fentanyl 2 micrograms/kilogram intranasal

Normal saline placebo intranasal

Outcomes

Primary Outcome Measures

Incidence of Pain
Pain greater than a zero reported in the Post Anesthesia Care Unit (PACU)

Secondary Outcome Measures

Length of Stay in PACU
Total time from PACU entry until discharge

Full Information

First Posted
April 3, 2008
Last Updated
March 28, 2011
Sponsor
Children's National Research Institute
Collaborators
Hospira, now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00654329
Brief Title
Dexmedetomidine vs Fentanyl for BMT
Acronym
DexBMT
Official Title
Dexmedetomidine for Peri-operative Sedation and Analgesia in Children Undergoing Bilateral Myringotomy With Tube Placement (BMT)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Children's National Research Institute
Collaborators
Hospira, now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis
Keywords
Dexmedetomidine, transmucosal, myringotomy,

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine 1microgram/kilogram
Arm Type
Experimental
Arm Description
Dexmedetomidine 1microgram/kilogram intranasal
Arm Title
Dexmedetomidine 2 micrograms/kilogram
Arm Type
Experimental
Arm Description
Dexmedetomidine 2 micrograms/kilogram intranasal
Arm Title
Fentanyl 2 micrograms/kilogram
Arm Type
Active Comparator
Arm Description
Fentanyl 2 micrograms/kilogram intranasal
Arm Title
Normal saline placebo
Arm Type
Placebo Comparator
Arm Description
Normal saline placebo intranasal
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
Normal Saline
Intervention Description
Normal saline, given intranasally
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Other Intervention Name(s)
Actiq, Fentora
Intervention Description
Fentanyl, nasal transmucosal, 2 micrograms/kilogram
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
Dexmedetomidine, transmucosal, 1 microgram/kilogram
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
Dexmedetomidine, 2 microgram/kilogram, transmucosal route
Primary Outcome Measure Information:
Title
Incidence of Pain
Description
Pain greater than a zero reported in the Post Anesthesia Care Unit (PACU)
Time Frame
up to 24 hours
Secondary Outcome Measure Information:
Title
Length of Stay in PACU
Description
Total time from PACU entry until discharge
Time Frame
up to 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for participation: The subject is 6 months to 6 years of age The subject's American Society of Anesthesiologists (ASA) physical status is ASA 1 or 2 (see appendix 1) The subject is scheduled for elective bilateral myringotomy with tube placement 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: The subject has a history or a family (parent or sibling) history of malignant hyperthermia The subject has known significant renal or hepatic disorders determined by medical history, physical examination or laboratory tests The subject has a known or suspected allergy to opioid analgesics or dexmedetomidine 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) The subject has know central nervous system disease or neurological impairment The subject is an ASA classification of 3 or greater (See Appendix 1) The subject has a medical condition requiring an intravenous induction (i.e. severe uncontrolled gastro-esophageal reflux) The subject refuses inhalation induction The subject is scheduled for a surgical sub-procedure (i.e. adenoidectomy, tonsillectomy)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia C Finkel, MD
Organizational Affiliation
Children's National Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States

12. IPD Sharing Statement

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Dexmedetomidine vs Fentanyl for BMT

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