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Individualized Analgesia for Pediatric Adenotonsillectomy

NCT04527393 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 542

Last updated 2024-02-28

No results posted yet for this study

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.

Conditions

  • Adenotonsillectomy
  • Analgesia

Interventions

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.

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.

Sponsors & Collaborators

  • Children's Hospital of Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2024-01-10
Completion
2024-01-10

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04527393 on ClinicalTrials.gov