NCT00587665

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Aug 2006

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 7, 2008

Completed
Last Updated

June 14, 2017

Status Verified

December 1, 2007

Enrollment Period

1.2 years

First QC Date

December 21, 2007

Last Update Submit

June 12, 2017

Conditions

Pain

Keywords

Pain

Outcome Measures

Primary Outcomes (1)

  • amount of post op narcotic use

    5 days

Secondary Outcomes (1)

  • degree of nausea and vomiting

    5 days

Study Arms (2)

1

EXPERIMENTAL

Low dose ketamine given

Drug: ketamine

2

PLACEBO COMPARATOR

Saline given as control

Drug: Placebo

Interventions

ketamineDRUG

Single IV dose of 0.1 mg/kg of ketamine

1
PlaceboDRUG

Saline given of equal volume to drug

2

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ASA 1 or 2

You may not qualify if:

  • did not consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Gregory Schears, md

    Mayo Clinic, Rochester, MN

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 7, 2008

Study Start

August 1, 2006

Primary Completion

October 1, 2007

Study Completion

December 1, 2007

Last Updated

June 14, 2017

Record last verified: 2007-12

Locations

US(1)