Individualized Analgesia for Pediatric Adenotonsillectomy

Analgesia Clinical Trial

Official title:

Effects of Individualized Opioid Analgesia Versus Conventional Opioid Analgesia After Adenotonsillectomy in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04527393
• Other study ID #: HL-001-2020
• Status: Completed
• Phase: Phase 4
• Start date: May 1, 2022
• Est. completion date: January 10, 2024

Study information

• Verified date: February 2024
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 542
• Est. completion date: January 10, 2024
• Est. primary completion date: January 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenotonsillectomy
• Analgesia

Intervention

Drug:
• Individualized oral morphine
Analgesic effectiveness is assessed using the Faces Scale by the parents every four hours from postoperative Day 1 to Day 10 (eg: 8:00, 12:00, 16:00, and 20:00, each day). If the Faces Scale score > 6, the child receive rescue oral morphine analgesia. Patients with positive results of fentanyl test receive oral morphine 100µg/kg per dose, while patients with negative results receive oral morphine 500µg/kg per dose.
• Conventional oral morphine
Analgesic effectiveness is assessed using the Faces Scale by the parents every four hours from postoperative Day 1 to Day 10 (eg: 8:00, 12:00, 16:00, and 20:00, each day). If the Faces Scale score > 6, the child receive rescue oral morphine analgesia. Patients receive oral morphine 200µg/kg per dose.

Locations

Country	Name	City	State
China	Children's hospital of Fudan university	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Desaturation events	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.	from postoperative day 1 to day 10, each night
Secondary	Scores of Pain Scale (the Faces Scale)	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.	every four hours from postoperative Day 1 to Day 10 (eg: 8:00, 12:00, 16:00, and 20:00, each day)
Secondary	Scores of Pain Scale (the Objective Pain Scale)	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.	every four hours from postoperative Day 1 to Day 10 (eg: 8:00, 12:00, 16:00, and 20:00, each day)
Secondary	Tonsillar bleeding events	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.	from postoperative day 1 to day 10
Secondary	Adverse drug reactions	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.	from postoperative day 1 to day 10