Methadone for Emergence Delirium in Children Undergoing Outpatient Strabismus Surgery
Sponsor
Ochsner Health System (Other)
Overall Status
Completed
CT.gov ID
NCT03778372
Collaborator
(none)
55
1
23.4
2.4
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Observational
Actual Enrollment
:
55 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Methadone for Emergence Delirium in Children Undergoing Outpatient Strabismus Surgery
Actual Study Start Date
:
Jan 1, 2019
Actual Primary Completion Date
:
Dec 13, 2020
Actual Study Completion Date
:
Dec 13, 2020
Arms and Interventions
| Arm | 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 |
Outcome Measures
Primary Outcome Measures
- Pediatric Anesthesia Emergence Delirium scale scores [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
Secondary Outcome Measures
- 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.]
A low total score would indicate less pain
- discharge time [24 hours]
time the patient is actually discharged from recovery room
Eligibility Criteria
Criteria
Ages Eligible for Study:
0 Years
to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- ASA I/II children undergoing outpatient strabismus surgery
Exclusion Criteria:
- anything not meeting the above
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ochsner Main Campus | Jefferson | Louisiana | United States | 70121 |
Sponsors and Collaborators
- Ochsner Health System
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
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.
- 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.
Responsible Party:
Khaled Dajani,
Assistant Professor,
Ochsner Health System
ClinicalTrials.gov Identifier:
NCT03778372
Other Study ID Numbers:
- Pro00014855
First Posted:
Dec 19, 2018
Last Update Posted:
Jul 19, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms: