Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy

NCT00654511

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.
Tonsillitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
2-12 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- All of the following criteria must be met for the potential subject to be eligible for participation:

1. The subject is 2 to 12 years of age

2. The subject's American Society of Anesthesiologists physical status is ASA I or II (see appendix 1).

3. The subject is scheduled for elective tonsillectomy with or without adenoidectomy surgery (procedures with myringotomy tube placement are allowed).

4. The subject will be hospitalized overnight after surgery

5. The subject's parent/legally authorized guardian has given written informed consent to participate; and where applicable, the subject has given appropriate assent to participate.

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


- The potential subject is NOT eligible for participation if any of the following
exclusion criteria apply:


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


4. The subject is a pregnant or lactating female (if post-menarcheal, a negative
pregnancy test must be confirmed prior to the planned surgery time (in AMSAC)
consistent with current standard of care.


5. The subject has history of. cardiovascular issues which would preclude the use of
dexmedetomidine, (e.g. Down's Syndrome, dysrhthymias, conditions where
hypotension is to be avoided).

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Advanced Information
Descriptive Information
Brief Title  ICMJE Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy
Official Title  ICMJE Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy.
Brief Summary

The primary purpose of this study is:

  1. To compare dexmedetomidine with fentanyl in terms of intra-operative hemodynamics and post-operative analgesia.
  2. To determine an analgesic dose response relationship for dexmedetomidine.
  3. Compare recovery characteristics of dexmedetomidine to fentanyl.
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, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Tonsillitis
Intervention  ICMJE
  • Drug: Fentanyl
    Fentanyl 1mcg/kg, Intravenous (IV)
    Other Name: Actiq
  • Drug: Fentanyl
    Fentanyl 2mcg/kg, Intravenous (IV)
    Other Name: Actiq
  • Drug: Dexmedetomidine
    Dexmedetomidine, 2mcg/kg, Intravenous (IV)
    Other Name: Precedex
  • Drug: Dexmedetomidine
    Dexmedetomidine, 4mcg/kg Intravenous (IV)
    Other Name: Precedex
Study Arms  ICMJE
  • Active Comparator: Fentanyl 1
    Fentanyl 1 micrograms (mcg)/kilogram (kg)
    Intervention: Drug: Fentanyl
  • Active Comparator: Fentanyl 2
    Fentanyl 2 micrograms (mcg)/kilogram (kg)
    Intervention: Drug: Fentanyl
  • Experimental: Dex 3
    Dexmedetomidine 2 micrograms (mcg)/kilogram (kg)
    Intervention: Drug: Dexmedetomidine
  • Experimental: Dex 4
    Dexmedetomidine 4 micrograms (mcg)/kilogram (kg)
    Intervention: Drug: Dexmedetomidine
Publications * Pestieau SR, Quezado ZM, Johnson YJ, Anderson JL, Cheng YI, McCarter RJ, Choi S, Finkel JC. High-dose dexmedetomidine increases the opioid-free interval and decreases opioid requirement after tonsillectomy in children. Can J Anaesth. 2011 Jun;58(6):540-50. doi: 10.1007/s12630-011-9493-7. Epub 2011 Apr 2.

*   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 7, 2008)
100
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All of the following criteria must be met for the potential subject to be eligible for participation:

    1. The subject is 2 to 12 years of age
    2. The subject's American Society of Anesthesiologists physical status is ASA I or II (see appendix 1).
    3. The subject is scheduled for elective tonsillectomy with or without adenoidectomy surgery (procedures with myringotomy tube placement are allowed).
    4. The subject will be hospitalized overnight after surgery
    5. The subject's parent/legally authorized guardian has given written informed consent to participate; and where applicable, the subject has given appropriate assent to participate.

      Exclusion Criteria:

  • The potential subject is NOT eligible for participation if any of the following exclusion criteria apply:

    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
    4. The subject is a pregnant or lactating female (if post-menarcheal, a negative pregnancy test must be confirmed prior to the planned surgery time (in AMSAC) consistent with current standard of care.
    5. The subject has history of. cardiovascular issues which would preclude the use of dexmedetomidine, (e.g. Down's Syndrome, dysrhthymias, conditions where hypotension is to be avoided).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 2 Years to 12 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 NCT00654511
Other Study ID Numbers  ICMJE 3502
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