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

This study has been completed.
Sponsor:
Collaborator:
Hospira, Inc.
Information provided by:
Children's Research Institute
ClinicalTrials.gov Identifier:
NCT00654511
First received: April 3, 2008
Last updated: March 28, 2011
Last verified: March 2011
  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
Tonsillitis
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Children's Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Julia C. Finkel, MD, Children's National Medical Center
ClinicalTrials.gov 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:
Dexmedetomidine,
fentanyl,
tonsillectomy
and adenoidectomy,

Additional relevant MeSH terms:
Tonsillitis
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Fentanyl
Dexmedetomidine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on October 01, 2014