Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06576830
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
Intraoperative Methadone for Pediatric Tonsillectomy Pain
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Single-Dose Intraoperative Methadone for Pain Management in Pediatric Tonsillectomy A Randomized Double Blind Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare the use of short acting opioids fentanylhydromorphone with long acting opioids methadone for pain control following tonsillectomy surgery in children and adolescents
Detailed Description:
This is a randomized double-blind parallel-group dose-escalation investigation Participants children defined as ages 3 - 12 years and adolescents defined as ages 12 - 17 years will be randomized 21 to either methadone or short-acting opioid Surgical and anesthesia care except for intraoperative opioid management are not altered for study purposes The trial will include 2 periods in 3 parallel age groups In the first period each age cohort will recruit 66 patients 44 methadone 22 control Children will be randomized to methadone 015 mgkg age-ideal body weight and adolescents to 02 mgkg age-ideal body weight When an age cohort reaches 66 patients this is the end of the first period At that time an unblinded interim analysis will be conducted in that cohort to determine if dose escalation to 02 mgkg dose in children and the 025 mgkg dose in adolescents are met Methadone dose escalation will be based on clinically meaningful differences in need for rescue opioid in the PACU and the absence of well-defined opioid adverse events Outcomes data will be collected in hospital and after discharge With daily surveys for 7 days and 3 phone calls on day 30 3 months and 6 months after surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None