DexT&A: Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy

Sponsor
Children's National Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT00654511
Collaborator
Hospira, now a wholly owned subsidiary of Pfizer (Industry)
101
1
4
45
2.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
101 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy.
Study Start Date :
Jan 1, 2005
Actual Primary Completion Date :
Oct 1, 2008
Actual Study Completion Date :
Oct 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Fentanyl 1

Fentanyl 1 micrograms (mcg)/kilogram (kg)

Drug: Fentanyl
Fentanyl 1mcg/kg, Intravenous (IV)
Other Names:
  • Actiq
  • Active Comparator: Fentanyl 2

    Fentanyl 2 micrograms (mcg)/kilogram (kg)

    Drug: Fentanyl
    Fentanyl 2mcg/kg, Intravenous (IV)
    Other Names:
  • Actiq
  • Experimental: Dex 3

    Dexmedetomidine 2 micrograms (mcg)/kilogram (kg)

    Drug: Dexmedetomidine
    Dexmedetomidine, 2mcg/kg, Intravenous (IV)
    Other Names:
  • Precedex
  • Experimental: Dex 4

    Dexmedetomidine 4 micrograms (mcg)/kilogram (kg)

    Drug: Dexmedetomidine
    Dexmedetomidine, 4mcg/kg Intravenous (IV)
    Other Names:
  • Precedex
  • Outcome Measures

    Primary Outcome Measures

    1. Time to First Morphine Dose [up to 24 hours]

      Total minutes from study medication administration to time of first morphine dose.

    2. Morphine Rescue [up to 24 hours]

      Total morphine administered in the Post Anesthesia Care Unit (PACU)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Children's National Medical Center Washington District of Columbia United States 20010

    Sponsors and Collaborators

    • Children's National Research Institute
    • Hospira, now a wholly owned subsidiary of Pfizer

    Investigators

    • Principal Investigator: Julia C Finkel, MD, Children's National Research Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Julia Finkel, MD, Children's National Research Institute
    ClinicalTrials.gov Identifier:
    NCT00654511
    Other Study ID Numbers:
    • 3502
    • Agreement #10698
    First Posted:
    Apr 8, 2008
    Last Update Posted:
    Mar 23, 2021
    Last Verified:
    Mar 1, 2021
    Keywords provided by Julia Finkel, MD, Children's National Research Institute
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Fentanyl 1 Microgram/Kilogram Intravenous (IV) Fentanyl 2 Micrograms/Kilogram Intravenous (IV) Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV) Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV)
    Arm/Group Description Fentanyl 1 microgram/kilogram IV given immediately after endotracheal intubation. Fentanyl 2 micrograms/kilogram IV given immediately after endotracheal intubation Dexmedetomidine 2mcg/kg given immediately after endotracheal intubation Dexmedetomidine 4mcg/kg given immediately after endotracheal intubation
    Period Title: Overall Study
    STARTED 26 25 25 25
    COMPLETED 26 25 25 25
    NOT COMPLETED 0 0 0 0

    Baseline Characteristics

    Arm/Group Title Fentanyl 1 Microgram/Kilogram Intravenous (IV) Fentanyl 2 Micrograms/Kilogram Intravenous (IV) Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV) Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV) Total
    Arm/Group Description Fentanyl 1 microgram/kilogram IV given immediately after endotracheal intubation. Fentanyl 2 micrograms/kilogram IV given immediately after endotracheal intubation Dexmedetomidine 2mcg/kg given immediately after endotracheal intubation Dexmedetomidine 4mcg/kg given immediately after endotracheal intubation Total of all reporting groups
    Overall Participants 26 25 25 25 101
    Age (Count of Participants)
    <=18 years
    26
    100%
    25
    100%
    25
    100%
    25
    100%
    101
    100%
    Between 18 and 65 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    4.17
    (2.33)
    4.83
    (2.45)
    5.17
    (2.33)
    4.92
    (2.27)
    4.77
    (2.34)
    Sex: Female, Male (Count of Participants)
    Female
    9
    34.6%
    11
    44%
    12
    48%
    11
    44%
    43
    42.6%
    Male
    17
    65.4%
    14
    56%
    13
    52%
    14
    56%
    58
    57.4%
    Region of Enrollment (participants) [Number]
    United States
    26
    100%
    25
    100%
    25
    100%
    25
    100%
    101
    100%

    Outcome Measures

    1. Primary Outcome
    Title Time to First Morphine Dose
    Description Total minutes from study medication administration to time of first morphine dose.
    Time Frame up to 24 hours

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Fentanyl 1 Microgram/Kilogram IV Fentanyl 2 Micrograms/Kilogram IV Dexmedetomidine 2 Microgram/Kilogram IV Dexmedetomidine 4 Micrograms/Kilogram IV
    Arm/Group Description
    Measure Participants 26 25 25 25
    Mean (Standard Deviation) [minutes]
    19
    (24.8)
    43.7
    (61.4)
    61.1
    (89.5)
    137.6
    (123.2)
    2. Primary Outcome
    Title Morphine Rescue
    Description Total morphine administered in the Post Anesthesia Care Unit (PACU)
    Time Frame up to 24 hours

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Fentanyl 1 Microgram/Kilogram Intravenous (IV) Fentanyl 2 Micrograms/Kilogram Intravenous (IV) Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV) Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV)
    Arm/Group Description Fentanyl 1 microgram/kilogram IV given immediately after endotracheal intubation. Fentanyl 2 micrograms/kilogram IV given immediately after endotracheal intubation Dexmedetomidine 2mcg/kg given immediately after endotracheal intubation Dexmedetomidine 4mcg/kg given immediately after endotracheal intubation
    Measure Participants 26 25 25 25
    Mean (Standard Deviation) [micrograms/kilogram]
    84
    (37)
    95
    (44)
    85
    (37)
    59
    (44)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Fentanyl 1 Microgram/Kilogram Intravenous (IV) Fentanyl 2 Micrograms/Kilogram Intravenous (IV) Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV) Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV)
    Arm/Group Description Fentanyl 1 microgram/kilogram IV given immediately after endotracheal intubation. Fentanyl 2 micrograms/kilogram IV given immediately after endotracheal intubation Dexmedetomidine 2mcg/kg given immediately after endotracheal intubation Dexmedetomidine 4mcg/kg given immediately after endotracheal intubation
    All Cause Mortality
    Fentanyl 1 Microgram/Kilogram Intravenous (IV) Fentanyl 2 Micrograms/Kilogram Intravenous (IV) Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV) Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Fentanyl 1 Microgram/Kilogram Intravenous (IV) Fentanyl 2 Micrograms/Kilogram Intravenous (IV) Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV) Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/26 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%)
    Other (Not Including Serious) Adverse Events
    Fentanyl 1 Microgram/Kilogram Intravenous (IV) Fentanyl 2 Micrograms/Kilogram Intravenous (IV) Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV) Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/26 (0%) 0/25 (0%) 0/25 (0%) 0/25 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Julia Finkel, MD
    Organization Children's National Medical Center
    Phone 202-476-4867 ext 4867
    Email jfinkel@cnmc.org
    Responsible Party:
    Julia Finkel, MD, Children's National Research Institute
    ClinicalTrials.gov Identifier:
    NCT00654511
    Other Study ID Numbers:
    • 3502
    • Agreement #10698
    First Posted:
    Apr 8, 2008
    Last Update Posted:
    Mar 23, 2021
    Last Verified:
    Mar 1, 2021