Methadone for Emergence Delirium in Children Undergoing Outpatient Strabismus Surgery

July 18, 2022 updated by: Khaled Dajani, Ochsner Health System
Strabismus surgery for children is a very common procedure, with a high incidence of emergence delirium in the recovery room. Pain is often implicated in delirium. The primary aim of this study is to determine whether a single, intraoperative dose of methadone for outpatient ambulatory pediatric strabismus surgery reduces postoperative delirium.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

55

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

1 second to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
study
pediatric patients undergoing outpatient strabismus surgery, and receiving methadone
Drug: Methadone
see desc above
control
pediatric patients undergoing outpatient strabismus surgery, and not receiving methadone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pediatric Anesthesia Emergence Delirium scale scores
Time Frame: measured every 10 minutes in the recovery room, until patient is discharged, up to 6 hours.
A low total score would indicate less emergence delirium
measured every 10 minutes in the recovery room, until patient is discharged, up to 6 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
wong-baker or numeric pain scores, depending on age
Time Frame: measured every 10 minutes in the recovery room, until patient is discharged, up to 6 hours.
A low total score would indicate less pain
measured every 10 minutes in the recovery room, until patient is discharged, up to 6 hours.
discharge time
Time Frame: 24 hours
time the patient is actually discharged from recovery room
24 hours

Collaborators and Investigators

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

Sponsor

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)

January 1, 2019

Primary Completion (Actual)

December 13, 2020

Study Completion (Actual)

December 13, 2020

Study Registration Dates

First Submitted

December 11, 2018

First Submitted That Met QC Criteria

December 17, 2018

First Posted (Actual)

December 19, 2018

Study Record Updates

Last Update Posted (Actual)

July 19, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00014855

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

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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