Low Dose Ketamine as an Adjunct to Fentanyl in Outpatient Tonsillectomy

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	Complete list of historical versions of study NCT00587665 on ClinicalTrials.gov Archive Site
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 Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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	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	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	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	Sexes Eligible for Study: All
Ages	3 Years to 12 Years (Child)
Accepts Healthy Volunteers	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	Not Provided
Responsible Party	Gregory J. Schears, MD, Mayo Clinic, Rochester, MN
Study Sponsor ICMJE	Mayo Clinic
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