Methadone for Emergence Delirium in Children Undergoing Outpatient Strabismus Surgery

Strabismus Clinical Trial

Official title:

Methadone for Emergence Delirium in Children Undergoing Outpatient Strabismus Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03778372
• Other study ID #: Pro00014855
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: December 13, 2020

Study information

• Verified date: July 2022
• Source: Ochsner Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 13, 2020
• Est. primary completion date: December 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• ASA I/II children undergoing outpatient strabismus surgery

Exclusion Criteria:

• anything not meeting the above

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium
• Strabismus

Intervention

Drug:
• Methadone
see desc above

Locations

Country	Name	City	State
United States	Ochsner Main Campus	Jefferson	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Ochsner Health System

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

Outcome

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