Dexmedetomidine in Pediatric Tonsillectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
OLUTOYIN A. OLUTOYE, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01057381
First received: January 25, 2010
Last updated: August 9, 2012
Last verified: August 2012
  Purpose

The hypothesis of this study is that the administration of an intra-operative dose of dexmedetomidine will result in adequate analgesia without respiratory depression thereby resulting in an early discharge from the post anesthetic care unit following adenotonsillectomy.


Condition Intervention Phase
Pediatric Adenotonsillectomy
Post Operative Analgesia
Drug: Dexmedetomidine 0.75 mcg/kg
Drug: Morphine 50 mcg/kg
Drug: Morphine 100 mcg/kg
Drug: Dexmedetomidine 1 mcg/kg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dose Response Relationship of Dexmedetomidine in Decreasing Post Operative Analgesic Requirements in the Pediatric Tonsillectomy Patient

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • opioid sparing effect of dexmedetomidine following adenotonsillectomy [ Time Frame: First hour following adenotonsillectomy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Degree of sedation [ Time Frame: Over the first hour following surgery ] [ Designated as safety issue: Yes ]

Enrollment: 109
Study Start Date: August 2005
Study Completion Date: December 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dexmedetomidine 0.75 mcg/kg
Intraoperative administration for analgesia.
Drug: Dexmedetomidine 0.75 mcg/kg
Single intra-operative administration of dexmedetomidine 0.75 mcg/kg over 10 minutes for analgesia.
Other Name: Precedex
Active Comparator: Dexmedetomidine 1mcg/kg
Intra-operative administration of dexmedetomidine 1 mcg/kg for analgesia
Drug: Dexmedetomidine 1 mcg/kg
Single intra-operative administration of dexmedetomidine 1 mcg/kg over 10 minutes for analgesia
Other Name: Precedex
Active Comparator: Morphine 50 mcg/kg
Intra-operative administration of morphine 50 mcg/kg for analgesia
Drug: Morphine 50 mcg/kg
Single intra-operative administration of morphine 50 mcg/kg over 10 minutes for analgesia
Other Name: Morphine
Active Comparator: Morphine 100mcg/kg
Intra-operative administration of morphine 100mcg/kg for analgesia
Drug: Morphine 100 mcg/kg
Single intra-operative dose of morphine 100 mcg/kg over 10 minutes for analgesia
Other Name: Morphine

Detailed Description:

Dexmedetomidine, an alpha 2 agonist provides some analgesia without respiratory depression. Children undergoing tonsillectomy and adenoidectomy occasionally have episodes of respiratory obstruction in the recovery room following administration of opioids.

As dexmedetomidine provides some analgesia without respiratory depression,an intra-operative dose of dexmedetomidine may provide adequate analgesia without significant side effects thereby allowing for quick post operative recovery.

  Eligibility

Ages Eligible for Study:   3 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children between ages 3 and 17 years with American Society of Anesthesiology classification 1 or 2.

Exclusion Criteria:

  • Children less than 3 years
  • Children with uncorrected cardiac lesions
  • Children with heart block or liver impairment
  • Children with American Society of Anesthesiology Class 3 or 4.
  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: NCT01057381

Locations
United States, Texas
Texas Children's Hospital, Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Olutoyin A Olutoye, M.D. Baylor College of Medicine
  More Information

No publications provided

Responsible Party: OLUTOYIN A. OLUTOYE, Associate Professor of Anesthesiology & Pediatrics, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01057381     History of Changes
Other Study ID Numbers: H-17558
Study First Received: January 25, 2010
Last Updated: August 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Baylor College of Medicine:
Adenotonsillectomy
Postoperative analgesia
Pediatrics

Additional relevant MeSH terms:
Morphine
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
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014