KETODEX for Emergence Delirium in Children Undergoing Outpatient Strabismus Surgery

December 17, 2018 updated by: Khaled Dajani, Ochsner Health System
Strabismus surgery for children is a very common procedure, with a high incidence of emergence delerium in the recovery room. A combination of intravenous ketamine/dexmedetomidine, or ketodex, has been previously shown to reduce emergence delerium in children undergoing adenotonsillectomy. Here, we study its application in strabismus surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Jefferson, Louisiana, United States, 70121
        • Ochsner Main Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy children, aged 0-18 years, undergoing outpatient strabismus surgery under general anesthesia

Description

Inclusion Criteria:

  • ASA I/II children undergoing outpatient strabismus surgery

Exclusion Criteria:

  • anything not meeting the above

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
control
pediatric patients undergoing outpatient strabismus surgery, and not receiving ketodex
study
pediatric patients undergoing outpatient strabismus surgery, and receiving ketodex
Drug: Dexmedetomidine
see descriptions
Other Names:
  • ketamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pediatric Anesthesia Emergence Delirium scale scores
Time Frame: up to 6 hours in recovery room
A low total score would indicate less emergence delirium
up to 6 hours in recovery room

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
wong-baker or numeric pain scores, depending on age
Time Frame: up to 6 hours in recovery room
A low total score would indicate less pain
up to 6 hours in recovery room
discharge time
Time Frame: up to 24 hours
time the patient is actually discharged from recovery room
up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ochsner Health System

Investigators

  • Principal Investigator: Khaled Dajani, MD, Ochsner Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2018

Primary Completion (Actual)

September 15, 2018

Study Completion (Actual)

September 15, 2018

Study Registration Dates

First Submitted

December 13, 2018

First Submitted That Met QC Criteria

December 17, 2018

First Posted (Actual)

December 19, 2018

Study Record Updates

Last Update Posted (Actual)

December 19, 2018

Last Update Submitted That Met QC Criteria

December 17, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00014439

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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