Low Dose Ketamine as an Adjunct to Fentanyl in Outpatient Tonsillectomy

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00587665
First received: December 21, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted

December 21, 2007
December 21, 2007
August 2006
October 2007   (final data collection date for primary outcome measure)
amount of post op narcotic use [ Time Frame: 5 days ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
degree of nausea and vomiting [ Time Frame: 5 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Low Dose Ketamine as an Adjunct to Fentanyl in Outpatient Tonsillectomy
A Prospective Study of Low Dose Ketamine as an Adjunct to Fentanyl in Pediatric Patients Following Outpatient Tonsillectomy and Adenoidectomy

Comparing patients receiving subanesthetic doses of Ketamine vs placebo to see if it can reduce narcotic needs for patients receiving a tonsillectomy and adenoidectomy

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pain
  • Drug: ketamine
    Single IV dose of 0.1 mg/kg of ketamine
  • Drug: Placebo
    Saline given of equal volume to drug
  • Experimental: 1
    Low dose ketamine given
    Intervention: Drug: ketamine
  • Placebo Comparator: 2
    Saline given as control
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
122
December 2007
October 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:between 3 and 12 years of age

  • ASA 1 or 2

Exclusion Criteria:

  • did not consent
Both
3 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00587665
1896-05
No
Gregory J. Schears, MD, Mayo Clinic, Rochester, MN
Mayo Clinic
Not Provided
Principal Investigator: Gregory Schears, md Mayo Clinic, Rochester, MN
Mayo Clinic
December 2007

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