Low Dose Ketamine as an Adjunct to Fentanyl in Outpatient Tonsillectomy
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ClinicalTrials.gov Identifier: NCT00587665 |
Recruitment Status :
Completed
First Posted : January 7, 2008
Last Update Posted : June 14, 2017
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Sponsor:
Mayo Clinic
Information provided by:
Mayo Clinic
Tracking Information | ||||
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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 |
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 |
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 |
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Condition ICMJE | Pain | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
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
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |