Low Dose Ketamine as an Adjunct to Fentanyl in Outpatient Tonsillectomy

• ClinicalTrials.gov Identifier: NCT00587665
• Recruitment Status: Completed
• First Posted: January 7, 2008
• Last Update Posted: June 14, 2017
• Sponsor: Mayo Clinic
• Information provided by: Mayo Clinic

Tracking Information

• First Submitted Date: December 21, 2007
• First Posted Date: January 7, 2008
• Last Update Posted Date: June 14, 2017
• Study Start Date: August 2006
• Actual Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 21, 2007): amount of post op narcotic use [ Time Frame: 5 days ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: December 21, 2007): degree of nausea and vomiting [ Time Frame: 5 days ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Low Dose Ketamine as an Adjunct to Fentanyl in Outpatient Tonsillectomy
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Pain

Intervention

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 21, 2007): 122
• Original Actual Enrollment: 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

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: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00587665
• Other Study ID Numbers: 1896-05
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Gregory J. Schears, MD, Mayo Clinic, Rochester, MN
• Original Responsible Party: Same as current
• Current Study Sponsor: Mayo Clinic
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Gregory Schears, md; Mayo Clinic, Rochester, MN

• PRS Account: Mayo Clinic
• Verification Date: December 2007