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Low Dose Ketamine as an Adjunct to Fentanyl in Outpatient Tonsillectomy

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00587665

First Posted: January 7, 2008

Last Update Posted: June 14, 2017

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.

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

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: 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

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

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

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

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

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