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

This study has been completed.
Hospira, Inc.
Information provided by:
Children's Research Institute Identifier:
First received: April 3, 2008
Last updated: March 28, 2011
Last verified: March 2011

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
Drug: Fentanyl
Drug: Dexmedetomidine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
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:
  • Time to First Morphine Dose [ Time Frame: up to 24 hours ] [ Designated as safety issue: No ]
    Total minutes from study medication administration to time of first morphine dose.

  • Morphine Rescue [ Time Frame: up to 24 hours ] [ Designated as safety issue: No ]
    Total morphine administered in the Post Anesthesia Care Unit (PACU)

Enrollment: 101
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
Active Comparator: Fentanyl 1
Fentanyl 1 micrograms (mcg)/kilogram (kg)
Drug: Fentanyl
Fentanyl 1mcg/kg, Intravenous (IV)
Other Name: Actiq
Active Comparator: Fentanyl 2
Fentanyl 2 micrograms (mcg)/kilogram (kg)
Drug: Fentanyl
Fentanyl 2mcg/kg, Intravenous (IV)
Other Name: Actiq
Experimental: Dex 3
Dexmedetomidine 2 micrograms (mcg)/kilogram (kg)
Drug: Dexmedetomidine
Dexmedetomidine, 2mcg/kg, Intravenous (IV)
Other Name: Precedex
Experimental: Dex 4
Dexmedetomidine 4 micrograms (mcg)/kilogram (kg)
Drug: Dexmedetomidine
Dexmedetomidine, 4mcg/kg Intravenous (IV)
Other Name: Precedex


Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: NCT00654511

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.
Principal Investigator: Julia C Finkel, MD Children's Research Institute
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Julia C. Finkel, MD, Children's National Medical Center Identifier: NCT00654511     History of Changes
Other Study ID Numbers: 3502  Agreement #10698 
Study First Received: April 3, 2008
Results First Received: February 23, 2011
Last Updated: March 28, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Otorhinolaryngologic Diseases
Pharyngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Stomatognathic Diseases
Adjuvants, Anesthesia
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics, Non-Narcotic
Analgesics, Opioid
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Depressants
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents processed this record on May 30, 2016