Dexmedetomidine vs Fentanyl for BMT

NCT00654329

Last updated date
Study Location
Children's National Medical Center
Washington, District of Columbia, 20010, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Otitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6 + months
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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)

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OtitisDexmedetomidine vs Fentanyl for BMT
NCT00654329
  1. Washington, District of Columbia
ALL GENDERS
6 Months+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Dexmedetomidine vs Fentanyl for BMT
Official Title  ICMJE Dexmedetomidine for Peri-operative Sedation and Analgesia in Children Undergoing Bilateral Myringotomy With Tube Placement (BMT)
Brief Summary A randomized controlled clinical trial to examine effects of intranasal dexmedetomidine, an ?2-adrenorecptor agonist, on pain control and agitation in children undergoing BMT.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Otitis
Intervention  ICMJE
  • Drug: Saline
    Normal saline, given intranasally
    Other Name: Normal Saline
  • Drug: Fentanyl
    Fentanyl, nasal transmucosal, 2 micrograms/kilogram
    Other Name: Actiq, Fentora
  • Drug: Dexmedetomidine
    Dexmedetomidine, transmucosal, 1 microgram/kilogram
    Other Name: Precedex
  • Drug: Dexmedetomidine
    Dexmedetomidine, 2 microgram/kilogram, transmucosal route
    Other Name: Precedex
Study Arms  ICMJE
  • Experimental: Dexmedetomidine 1microgram/kilogram
    Dexmedetomidine 1microgram/kilogram intranasal
    Intervention: Drug: Dexmedetomidine
  • Experimental: Dexmedetomidine 2 micrograms/kilogram
    Dexmedetomidine 2 micrograms/kilogram intranasal
    Intervention: Drug: Dexmedetomidine
  • Active Comparator: Fentanyl 2 micrograms/kilogram
    Fentanyl 2 micrograms/kilogram intranasal
    Intervention: Drug: Fentanyl
  • Placebo Comparator: Normal saline placebo
    Normal saline placebo intranasal
    Intervention: Drug: Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 7, 2010)
101
Original Estimated Enrollment  ICMJE
 (submitted: April 3, 2008)
160
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 6 Months to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00654329
Other Study ID Numbers  ICMJE 3641
Agreement # 10698
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Julia C. Finkel, MD, Children's National Medical Center
Study Sponsor  ICMJE Children's National Research Institute
Collaborators  ICMJE Hospira, now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator:Julia C Finkel, MDChildren's National Research Institute
PRS Account Children's National Research Institute
Verification Date March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP