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

Primary Purpose

Tonsillitis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fentanyl
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 Tonsillitis focused on measuring Dexmedetomidine,, fentanyl,, tonsillectomy, and adenoidectomy,

Eligibility Criteria

2 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Children's National Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Experimental

Experimental

Arm Label

Fentanyl 1

Fentanyl 2

Dex 3

Dex 4

Arm Description

Fentanyl 1 micrograms (mcg)/kilogram (kg)

Fentanyl 2 micrograms (mcg)/kilogram (kg)

Dexmedetomidine 2 micrograms (mcg)/kilogram (kg)

Dexmedetomidine 4 micrograms (mcg)/kilogram (kg)

Outcomes

Primary Outcome Measures

Time to First Morphine Dose
Total minutes from study medication administration to time of first morphine dose.
Morphine Rescue
Total morphine administered in the Post Anesthesia Care Unit (PACU)

Secondary Outcome Measures

Full Information

First Posted
April 3, 2008
Last Updated
March 1, 2021
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
NCT00654511
Brief Title
Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy
Acronym
DexT&A
Official Title
Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
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
The primary purpose of this study is: To compare dexmedetomidine with fentanyl in terms of intra-operative hemodynamics and post-operative analgesia. To determine an analgesic dose response relationship for dexmedetomidine. Compare recovery characteristics of dexmedetomidine to fentanyl.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tonsillitis
Keywords
Dexmedetomidine,, fentanyl,, tonsillectomy, and adenoidectomy,

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Fentanyl 1
Arm Type
Active Comparator
Arm Description
Fentanyl 1 micrograms (mcg)/kilogram (kg)
Arm Title
Fentanyl 2
Arm Type
Active Comparator
Arm Description
Fentanyl 2 micrograms (mcg)/kilogram (kg)
Arm Title
Dex 3
Arm Type
Experimental
Arm Description
Dexmedetomidine 2 micrograms (mcg)/kilogram (kg)
Arm Title
Dex 4
Arm Type
Experimental
Arm Description
Dexmedetomidine 4 micrograms (mcg)/kilogram (kg)
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Other Intervention Name(s)
Actiq
Intervention Description
Fentanyl 1mcg/kg, Intravenous (IV)
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Other Intervention Name(s)
Actiq
Intervention Description
Fentanyl 2mcg/kg, Intravenous (IV)
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
Dexmedetomidine, 2mcg/kg, Intravenous (IV)
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
Dexmedetomidine, 4mcg/kg Intravenous (IV)
Primary Outcome Measure Information:
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
Title
Morphine Rescue
Description
Total morphine administered in the Post Anesthesia Care Unit (PACU)
Time Frame
up to 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All of the following criteria must be met for the potential subject to be eligible for participation: The subject is 2 to 12 years of age The subject's American Society of Anesthesiologists physical status is ASA I or II (see appendix 1). The subject is scheduled for elective tonsillectomy with or without adenoidectomy surgery (procedures with myringotomy tube placement are allowed). The subject will be hospitalized overnight after surgery 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: 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 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. 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).
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

Citations:
PubMed Identifier
21461792
Citation
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.
Results Reference
derived

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Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy

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