NCT04527393

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
542

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2020

Completed
1.7 years until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2024

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

1.7 years

First QC Date

August 24, 2020

Last Update Submit

February 23, 2024

Conditions

AdenotonsillectomyAnalgesia

Keywords

adenotonsillectomyindividualized opioid analgesiarespiratory parameterschildren

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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)

  • 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)

  • Tonsillar bleeding events

    from postoperative day 1 to day 10

  • Adverse drug reactions

    from postoperative day 1 to day 10

Study Arms (2)

individualized opioid analgesia regimen group

EXPERIMENTAL

The dose of oral morphine for patients in the individualized group is determined according to the results of fentanyl test.

Drug: Individualized oral morphine

conventional opioid analgesia regimen group

ACTIVE COMPARATOR

Patients in the conventional group are given routine dose of oral morphine.

Drug: Conventional oral morphine

Interventions

Individualized oral morphineDRUG

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.

Also known as: Individualized group
individualized opioid analgesia regimen group
Conventional oral morphineDRUG

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.

Also known as: Conventional group
conventional opioid analgesia regimen group

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's hospital of Fudan university

Shanghai, China

Location

Related Publications (1)

  • Liu HE, He L. The performance of a post-induction fentanyl-test in predicting postoperative respiratory adverse events in children after adenotonsillectomy. J Clin Sleep Med. 2024 Nov 1;20(11):1749-1754. doi: 10.5664/jcsm.11262.

    PMID: 38935059DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2020

First Posted

August 26, 2020

Study Start

May 1, 2022

Primary Completion

January 10, 2024

Study Completion

January 10, 2024

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)