Low Dose Ketamine as an Adjunct to Fentanyl in Outpatient Tonsillectomy

NCT ID: NCT00587665

Last Updated: 2017-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2007-12-31

Brief Summary

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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

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Low dose ketamine given

Group Type EXPERIMENTAL

ketamine

Intervention Type DRUG

Single IV dose of 0.1 mg/kg of ketamine

2

Saline given as control

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Saline given of equal volume to drug

Interventions

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ketamine

Single IV dose of 0.1 mg/kg of ketamine

Intervention Type DRUG

Placebo

Saline given of equal volume to drug

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ASA 1 or 2

Exclusion Criteria

* did not consent
Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mayo Clinic, Rochester, MN

Principal Investigators

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Gregory Schears, md

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic, Rochester, MN

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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1896-05

Identifier Type: -

Identifier Source: org_study_id

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