Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-25 @ 11:30 PM
Study NCT ID:
NCT04527393
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2020-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Individualized Analgesia for Pediatric Adenotonsillectomy
Sponsor:
Children's Hospital of Fudan University
Organization:
Study Overview
Official Title:
Effects of Individualized Opioid Analgesia Versus Conventional Opioid Analgesia After Adenotonsillectomy in Children
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this randomized clinical trial is to assess the safety and effectiveness of post-adenotonsillectomy analgesia with individualized opioid analgesia regime in children.
Detailed Description:
Patients will be randomly assigned to individualized opioid analgesia regimen group or conventional opioid analgesia regimen group.
Intravenous 1μg/kg fentanyl is administered as a test in patients with spontaneous breath after sevoflurane induction. A positive result is defined as a decrease of more than 50% in spontaneous respiratory rate (rate after fentanyl test versus rate before fentanyl test). Otherwise it is defined as a negative result.
All the patients are given regular paracetamol and ibuprofen after surgery. The addition of rescue oral morphine is given as needed. The dose of oral morphine is determined according to the results of fentanyl test in the individualized group, while the patients in the conventional group are given the routine dose. The Faces Scale is used to assess analgesic effectiveness by parents from postoperative day 1 to day 10. If the Faces Scale score \> 6, the child receive rescue oral morphine analgesia.
At the preoperative appointment, parents are provided with a pulse oximeter including oxygen saturation sensors to take home. The oxygen saturation per night during sleep will be monitored using the pulse oximeter by parents from postoperative Day 1 to Day 10. The research team will instruct parents on how to properly apply the oximeter to the child and repeat these measurements. The primary outcome measure is desaturation events during sleep per night.
Intravenous 1μg/kg fentanyl is administered as a test in patients with spontaneous breath after sevoflurane induction. A positive result is defined as a decrease of more than 50% in spontaneous respiratory rate (rate after fentanyl test versus rate before fentanyl test). Otherwise it is defined as a negative result.
All the patients are given regular paracetamol and ibuprofen after surgery. The addition of rescue oral morphine is given as needed. The dose of oral morphine is determined according to the results of fentanyl test in the individualized group, while the patients in the conventional group are given the routine dose. The Faces Scale is used to assess analgesic effectiveness by parents from postoperative day 1 to day 10. If the Faces Scale score \> 6, the child receive rescue oral morphine analgesia.
At the preoperative appointment, parents are provided with a pulse oximeter including oxygen saturation sensors to take home. The oxygen saturation per night during sleep will be monitored using the pulse oximeter by parents from postoperative Day 1 to Day 10. The research team will instruct parents on how to properly apply the oximeter to the child and repeat these measurements. The primary outcome measure is desaturation events during sleep per night.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: