IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Low Dose Ketamine as an Adjunct to Fentanyl in Outpatient Tonsillectomy
This study has been completed.
Sponsor:
Mayo Clinic
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00587665
First received: December 21, 2007
Last updated: June 12, 2017
Last verified: December 2007
| Tracking Information | ||||
|---|---|---|---|---|
| First Received Date ICMJE | December 21, 2007 | |||
| Last Updated Date | June 12, 2017 | |||
| Start Date ICMJE | August 2006 | |||
| 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 | Complete list of historical versions of study NCT00587665 on ClinicalTrials.gov Archive Site | |||
| Current Secondary Outcome Measures ICMJE |
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 Provided | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Participant, Care Provider, Investigator, Outcomes Assessor Primary Purpose: Treatment |
|||
| Condition ICMJE | Pain | |||
| Intervention ICMJE |
|
|||
| Study Arms |
|
|||
| 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 | |||
| Enrollment ICMJE | 122 | |||
| Completion Date | December 2007 | |||
| 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:
|
|||
| Sex/Gender |
|
|||
| 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 | |||
| Plan to Share Data | Not Provided | |||
| IPD Description | Not Provided | |||
| Responsible Party | Gregory J. Schears, MD, Mayo Clinic, Rochester, MN | |||
| Study Sponsor ICMJE | Mayo Clinic | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
|
|||
| 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 |
||||