Individualized Analgesia for Pediatric Adenotonsillectomy

• ClinicalTrials.gov Identifier: NCT04527393
• Recruitment Status: Not yet recruiting
• First Posted: August 26, 2020
• Last Update Posted: February 9, 2022
• Sponsor: Children's Hospital of Fudan University
• Information provided by (Responsible Party): Children's Hospital of Fudan University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Adenotonsillectomy; Analgesia	Drug: Individualized oral morphine; Drug: Conventional oral morphine	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 128 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of Individualized Opioid Analgesia Versus Conventional Opioid Analgesia After Adenotonsillectomy in Children
• Estimated Study Start Date: May 2022
• Estimated Primary Completion Date: June 2023
• Estimated Study Completion Date: December 2023

Arms and Interventions

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.
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.

Outcome Measures

Primary Outcome Measures :

1. Desaturation events [ Time Frame: 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 :

1. Scores of Pain Scale (the Faces Scale) [ Time Frame: 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.
2. Scores of Pain Scale (the Objective Pain Scale) [ Time Frame: 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.
3. Tonsillar bleeding events [ Time Frame: 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.
4. Adverse drug reactions [ Time Frame: 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.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Contacts

Contact: Lin He, MD; (86)13901740886; sarahhelin@163.com

Sponsors and Collaborators

Children's Hospital of Fudan University

More Information

• Responsible Party: Children's Hospital of Fudan University
• ClinicalTrials.gov Identifier: NCT04527393
• Other Study ID Numbers: HL-001-2020
• First Posted: August 26, 2020
• Last Update Posted: February 9, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Children's Hospital of Fudan University:

adenotonsillectomy; individualized opioid analgesia; respiratory parameters; children

Additional relevant MeSH terms:

Agnosia; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Morphine; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents