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Low Dose Ketamine as an Adjunct to Fentanyl in Outpatient 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: NCT00587665
Recruitment Status : Completed
First Posted : January 7, 2008
Last Update Posted : June 14, 2017
Sponsor:
Information provided by:
Mayo Clinic

Tracking Information
First Submitted Date  ICMJE December 21, 2007
First Posted Date  ICMJE January 7, 2008
Last Update Posted Date June 14, 2017
Study Start Date  ICMJE August 2006
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
amount of post op narcotic use [ Time Frame: 5 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
degree of nausea and vomiting [ Time Frame: 5 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low Dose Ketamine as an Adjunct to Fentanyl in Outpatient Tonsillectomy
Official Title  ICMJE A Prospective Study of Low Dose Ketamine as an Adjunct to Fentanyl in Pediatric Patients Following Outpatient Tonsillectomy and Adenoidectomy
Brief Summary Comparing patients receiving subanesthetic doses of Ketamine vs placebo to see if it can reduce narcotic needs for patients receiving a tonsillectomy and adenoidectomy
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: ketamine
    Single IV dose of 0.1 mg/kg of ketamine
  • Drug: Placebo
    Saline given of equal volume to drug
Study Arms  ICMJE
  • Experimental: 1
    Low dose ketamine given
    Intervention: Drug: ketamine
  • Placebo Comparator: 2
    Saline given as control
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2007)
122
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:between 3 and 12 years of age

  • ASA 1 or 2

Exclusion Criteria:

  • did not consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00587665
Other Study ID Numbers  ICMJE 1896-05
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Gregory J. Schears, MD, Mayo Clinic, Rochester, MN
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Mayo Clinic
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gregory Schears, md Mayo Clinic, Rochester, MN
PRS Account Mayo Clinic
Verification Date December 2007

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