Individualized Analgesia for Pediatric Adenotonsillectomy

Phase 4

Completed

• Conditions: Adenotonsillectomy; Analgesia
• Interventions: Drug: Individualized oral morphine; Drug: Conventional oral morphine

• Registration Number: NCT04527393
• Lead Sponsor: Children's Hospital of Fudan University

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.

Study Timeline

• Study First Submitted: 2020-08-24
• Study First Submitted QC: 2020-08-24
• Study First Posted: 2020-08-26
• Study Start: 2022-05-01
• Primary Completion: 2024-01-10
• Study Completion: 2024-01-10
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 542

Inclusion Criteria

• Children, ASA physical status I or II, who is scheduled to undergo adenotonsillectomy will be recruited.

Exclusion Criteria

• Children with craniofacial deformities, neuromuscular diseases, mental retardation, body mass index > 30kg/m2 , or a recent history of opioid use are excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
individualized opioid analgesia regimen group	Individualized oral morphine	The dose of oral morphine for patients in the individualized group is determined according to the results of fentanyl test.
conventional opioid analgesia regimen group	Conventional oral morphine	Patients in the conventional group are given routine dose of oral morphine.

Primary Outcome Measures

Name	Time	Method
Desaturation events	from postoperative day 1 to day 10, each night	The oxygen saturation per night during sleep will be monitored using a pulse oximeter by the 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.

Secondary Outcome Measures

Name	Time	Method
Scores of Pain Scale (the Faces Scale)	every four hours from postoperative Day 1 to Day 10 (eg: 8:00, 12:00, 16:00, and 20:00, each day)	Analgesic effectiveness was assessed using the Faces Scale by the parents every four hours from postoperative Day 1 to Day 10. Parents are trained by the research staff on how to complete pain scale.
Scores of Pain Scale (the Objective Pain Scale)	every four hours from postoperative Day 1 to Day 10 (eg: 8:00, 12:00, 16:00, and 20:00, each day)	Analgesic effectiveness was assessed using the Objective Pain Scale by the parents every four hours from postoperative Day 1 to Day 10. Parents are trained by the research staff on how to complete pain scale.
Tonsillar bleeding events	from postoperative day 1 to day 10	This include any signs of significant oral or nasal bleeding. It is recorded by the parents as occurring or not; if so, the number of occurrences and the time of each occurrence should be recorded.
Adverse drug reactions	from postoperative day 1 to day 10	It is recorded by the parents as occurring or not; if so, the time of occurrence and the type of adverse reaction need to be recorded.

Trial Locations

Locations (1)

Children's hospital of Fudan university; 🇨🇳 Shanghai, China