Methadone for Emergence Delirium in Children Undergoing Outpatient Strabismus Surgery

NCT ID: NCT03778372

Last Updated: 2022-07-19

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

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-12-13

Brief Summary

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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.

Detailed Description

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Conditions

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Emergence Delirium Strabismus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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study

pediatric patients undergoing outpatient strabismus surgery, and receiving methadone

Methadone

Intervention Type DRUG

see desc above

control

pediatric patients undergoing outpatient strabismus surgery, and not receiving methadone

No interventions assigned to this group

Interventions

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Methadone

see desc above

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ASA I/II children undergoing outpatient strabismus surgery

Exclusion Criteria

* anything not meeting the above
Minimum Eligible Age

0 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ochsner Health System

OTHER

Sponsor Role lead

Responsible Party

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Khaled Dajani

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ochsner Main Campus

Jefferson, Louisiana, United States

Site Status

Countries

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United States

References

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Komen H, Brunt LM, Deych E, Blood J, Kharasch ED. Intraoperative Methadone in Same-Day Ambulatory Surgery: A Randomized, Double-Blinded, Dose-Finding Pilot Study. Anesth Analg. 2019 Apr;128(4):802-810. doi: 10.1213/ANE.0000000000003464.

Reference Type BACKGROUND
PMID: 29847382 (View on PubMed)

Ward RM, Drover DR, Hammer GB, Stemland CJ, Kern S, Tristani-Firouzi M, Lugo RA, Satterfield K, Anderson BJ. The pharmacokinetics of methadone and its metabolites in neonates, infants, and children. Paediatr Anaesth. 2014 Jun;24(6):591-601. doi: 10.1111/pan.12385. Epub 2014 Mar 26.

Reference Type BACKGROUND
PMID: 24666686 (View on PubMed)

Other Identifiers

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Pro00014855

Identifier Type: -

Identifier Source: org_study_id

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