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History of Changes for Study: NCT00587665
Low Dose Ketamine as an Adjunct to Fentanyl in Outpatient Tonsillectomy
Latest version (submitted June 12, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 21, 2007 None (earliest Version on record)
2 June 12, 2017 Study Status
Comparison Format:

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Study NCT00587665
Submitted Date:  December 21, 2007 (v1)

Open or close this module Study Identification
Unique Protocol ID: 1896-05
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
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2007
Overall Status: Completed
Study Start: August 2006
Primary Completion: October 2007 [Actual]
Study Completion: December 2007 [Actual]
First Submitted: December 21, 2007
First Submitted that
Met QC Criteria:
December 21, 2007
First Posted: January 7, 2008 [Estimate]
Last Update Submitted that
Met QC Criteria:
December 21, 2007
Last Update Posted: January 7, 2008 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Mayo Clinic
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Pain
Keywords: Pain
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 122 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: 1
Low dose ketamine given
Drug: ketamine
Single IV dose of 0.1 mg/kg of ketamine
Placebo Comparator: 2
Saline given as control
Drug: Placebo
Saline given of equal volume to drug
Open or close this module Outcome Measures
Primary Outcome Measures:
1. amount of post op narcotic use
[ Time Frame: 5 days ]

Secondary Outcome Measures:
1. degree of nausea and vomiting
[ Time Frame: 5 days ]

Open or close this module Eligibility
Minimum Age: 3 Years
Maximum Age: 12 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:between 3 and 12 years of age

  • ASA 1 or 2

Exclusion Criteria:

  • did not consent
Open or close this module Contacts/Locations
Study Officials: Gregory Schears, md
Principal Investigator
Mayo Clinic, Rochester, MN
Locations: United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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