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Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy (DexT&A)
This study has been completed.
First Received: April 3, 2008   Last Updated: January 29, 2009   History of Changes
Sponsor: Children's Research Institute
Collaborator: Hospira, Inc.
Information provided by: Children's Research Institute
ClinicalTrials.gov Identifier: NCT00654511
  Purpose

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.

Condition Intervention Phase
Dex vs. Fent. Intra-Oper. Hemodyn. & Post-Oper. Analg.
Analgesic Dose Response Relationship for Dexm.
Recovery Charac. of Dexmedetomidine vs. Fentanyl.
Drug: Fentanyl
Drug: Dexmedetomidine
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Post operative analgesia [ Time Frame: postoperative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intraoperative hemodynamics [ Time Frame: Perioperative ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: January 2005
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Fentanyl
Drug: Fentanyl
Fentanyl 1mcg/kg, IV
2: Active Comparator
Fentanyl
Drug: Fentanyl
Fentanyl 2mcg/kg, IV
3: Experimental
Dexmedetomidine
Drug: Dexmedetomidine
Dexmedetomidine, 2mcg/kg, IV
4: Experimental
Dexmedetomidine
Drug: Dexmedetomidine
Dexmedetomidine, IV, 4mcg/kg

  Eligibility

Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00654511

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: 3502, Agreement #10698
Study First Received: April 3, 2008
Last Updated: January 29, 2009
ClinicalTrials.gov Identifier: NCT00654511     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Research Institute:
Dexmedetomidine,
fentanyl,
tonsillectomy
and adenoidectomy,

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 February 08, 2010