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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
History of Changes

January 25, 2010
August 9, 2012
August 2005
November 2010   (final data collection date for primary outcome measure)
opioid sparing effect of dexmedetomidine following adenotonsillectomy [ Time Frame: First hour following adenotonsillectomy ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01057381 on ClinicalTrials.gov Archive Site
Degree of sedation [ Time Frame: Over the first hour following surgery ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Dexmedetomidine in Pediatric Tonsillectomy
Dose Response Relationship of Dexmedetomidine in Decreasing Post Operative Analgesic Requirements in the Pediatric Tonsillectomy Patient

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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Pediatric Adenotonsillectomy
  • Post Operative 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
  • Drug: Morphine 50 mcg/kg
    Single intra-operative administration of morphine 50 mcg/kg over 10 minutes for analgesia
    Other Name: Morphine
  • Drug: Morphine 100 mcg/kg
    Single intra-operative dose of morphine 100 mcg/kg over 10 minutes for analgesia
    Other Name: Morphine
  • Drug: Dexmedetomidine 1 mcg/kg
    Single intra-operative administration of dexmedetomidine 1 mcg/kg over 10 minutes for analgesia
    Other Name: Precedex
  • Active Comparator: Dexmedetomidine 0.75 mcg/kg
    Intraoperative administration for analgesia.
    Intervention: Drug: Dexmedetomidine 0.75 mcg/kg
  • Active Comparator: Dexmedetomidine 1mcg/kg
    Intra-operative administration of dexmedetomidine 1 mcg/kg for analgesia
    Intervention: Drug: Dexmedetomidine 1 mcg/kg
  • Active Comparator: Morphine 50 mcg/kg
    Intra-operative administration of morphine 50 mcg/kg for analgesia
    Intervention: Drug: Morphine 50 mcg/kg
  • Active Comparator: Morphine 100mcg/kg
    Intra-operative administration of morphine 100mcg/kg for analgesia
    Intervention: Drug: Morphine 100 mcg/kg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
109
December 2010
November 2010   (final data collection date for primary outcome measure)

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.
Both
3 Years to 17 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01057381
H-17558
Yes
OLUTOYIN A. OLUTOYE, Baylor College of Medicine
Baylor College of Medicine
Not Provided
Principal Investigator: Olutoyin A Olutoye, M.D. Baylor College of Medicine
Baylor College of Medicine
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP