ClinicalTrials.gov
ClinicalTrials.gov Menu

Dexmedetomidine in Pediatric Tonsillectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01057381
Recruitment Status : Completed
First Posted : January 27, 2010
Last Update Posted : August 10, 2012
Sponsor:
Information provided by (Responsible Party):
OLUTOYIN A. OLUTOYE, Baylor College of Medicine

Brief Summary:
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 or disease Intervention/treatment 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

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dose Response Relationship of Dexmedetomidine in Decreasing Post Operative Analgesic Requirements in the Pediatric Tonsillectomy Patient
Study Start Date : August 2005
Actual Primary Completion Date : November 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. opioid sparing effect of dexmedetomidine following adenotonsillectomy [ Time Frame: First hour following adenotonsillectomy ]

Secondary Outcome Measures :
  1. Degree of sedation [ Time Frame: Over the first hour following surgery ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: January 27, 2010    Key Record Dates
Last Update Posted: August 10, 2012
Last Verified: August 2012

Keywords provided by OLUTOYIN A. OLUTOYE, 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
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
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