Individualized Analgesia for Pediatric Adenotonsillectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Analgesia; Adenotonsillectomy
• Intervention / Treatment: Drug: Individualized oral morphine; Drug: Conventional oral morphine

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 Type: Interventional
• Enrollment (Actual): 542
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Lin He, MD; Phone Number: (86)13901740886; Email: sarahhelin@163.com

Study Locations

• China
  • Shanghai, China
    • Children's Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 10 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: individualized opioid analgesia regimen group; The dose of oral morphine for patients in the individualized group is determined according to the results of fentanyl test.	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.; Other Names: Individualized group
Active Comparator: conventional opioid analgesia regimen group; Patients in the conventional group are given routine dose of oral morphine.	Drug: 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.; Other Names: Conventional group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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
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

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): January 10, 2024
• Study Completion (Actual): January 10, 2024

Study Registration Dates

• First Submitted: August 24, 2020
• First Submitted That Met QC Criteria: August 24, 2020
• First Posted (Actual): August 26, 2020

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: children; adenotonsillectomy; respiratory parameters; individualized opioid analgesia
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: HL-001-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No