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CompletedNCT03778372Updated Jul 19, 2022

Methadone for Emergence Delirium in Children Undergoing Outpatient Strabismus Surgery

An observational study in Emergence Delirium and Strabismus, sponsored by Ochsner Health System. Completed at 1 site in United States. Open to participants aged 0 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-19.

Sponsored by Ochsner Health System · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
55
Ages
0 Years to 18 Years
Sex
All
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Study summary

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.

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Conditions studied

  • Emergence Delirium
  • Strabismus
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In context

Delirium

1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.

This study's enrollment of 55 is below the median of 200 across 418 observational studies indexed under Delirium.

Browse Delirium studies →

Lead sponsor

Ochsner Health System is the lead sponsor of 54 studies on the registry; 7 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
0 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • ASA I/II children undergoing outpatient strabismus surgery

Exclusion criteria

Exclusion Criteria:

  • anything not meeting the above
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
55 participants (actual)
Patient registry
No

Groups and cohorts

  • study

    pediatric patients undergoing outpatient strabismus surgery, and receiving methadone

    Drug: Methadone

  • control

    pediatric patients undergoing outpatient strabismus surgery, and not receiving methadone

Interventions

  • DrugMethadone

    see desc above

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What researchers measure

Primary outcomes

  1. Pediatric Anesthesia Emergence Delirium scale scores

    A low total score would indicate less emergence delirium

    Time frame: measured every 10 minutes in the recovery room, until patient is discharged, up to 6 hours.

Secondary outcomes

  1. wong-baker or numeric pain scores, depending on age

    A low total score would indicate less pain

    Time frame: measured every 10 minutes in the recovery room, until patient is discharged, up to 6 hours.

  2. discharge time

    time the patient is actually discharged from recovery room

    Time frame: 24 hours

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Study locations

1 site
  • Ochsner Main Campus
    Jefferson, Louisiana 70121, United States
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References and documents

Publications

  • 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. PubMed 29847382 ↗
  • 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. PubMed 24666686 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03778372
Lead sponsor
Ochsner Health System
Responsible party
Khaled Dajani (Assistant Professor, Ochsner Health System) — Principal investigator
First posted
Dec 19, 2018
Start date
Jan 1, 2019
Primary completion
Dec 13, 2020
Completion
Dec 13, 2020
Last update
Jul 19, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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