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Low Dose Ketamine as an Adjunct to Fentanyl in Outpatient Tonsillectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00587665
First Posted: January 7, 2008
Last Update Posted: June 14, 2017
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.
Information provided by:
Mayo Clinic
December 21, 2007
January 7, 2008
June 14, 2017
August 2006
October 2007   (Final data collection date for primary outcome measure)
amount of post op narcotic use [ Time Frame: 5 days ]
Same as current
Complete list of historical versions of study NCT00587665 on ClinicalTrials.gov Archive Site
degree of nausea and vomiting [ Time Frame: 5 days ]
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
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, 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
Sexes Eligible for Study: All
3 Years to 12 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00587665
1896-05
No
Not Provided
Not Provided
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
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