Methadone for Emergence Delirium in Children Undergoing Outpatient Strabismus Surgery

NCT03778372 | Completed FDA Drug

• 1 other identifier: Pro00014855
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Emergence Delirium; Strabismus

Outcome Measures

Primary Outcomes (1)

• Pediatric Anesthesia Emergence Delirium scale scores

  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 Outcomes (2)

• wong-baker or numeric pain scores, depending on age

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

• discharge time

  24 hours

Study Arms (2)

study

pediatric patients undergoing outpatient strabismus surgery, and receiving methadone

Drug: Methadone

control

pediatric patients undergoing outpatient strabismus surgery, and not receiving methadone

Interventions

Methadone DRUG

see desc above

study

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• ASA I/II children undergoing outpatient strabismus surgery

You may not qualify if:

• anything not meeting the above

Sponsors & Collaborators

• Ochsner Health System: lead

Study Sites (1)

Ochsner Main Campus

Jefferson, Louisiana, 70121, United States

Location

Related Publications (2)

• 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.

  PMID: 29847382 BACKGROUND

• 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.

  PMID: 24666686 BACKGROUND

MeSH Terms

Conditions

Emergence Delirium; Strabismus

Interventions

Methadone

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Ocular Motility Disorders; Cranial Nerve Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: December 19, 2018
• Study Start: January 1, 2019
• Primary Completion: December 13, 2020
• Study Completion: December 13, 2020
• Last Updated: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)