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Clinical trial

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

ID
Name
HL-001-2020
Description
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 arms
Trial start
2022-05-01
Estimated PCD
2024-01-10
Trial end
2024-01-10
Status
Completed
Phase
Early phase I
Treatment
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.
Arms:
individualized opioid analgesia regimen group
Other names:
Individualized group
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.
Arms:
conventional opioid analgesia regimen group
Other names:
Conventional group
Size
542
Primary endpoint
Desaturation events
from postoperative day 1 to day 10, each night
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 542, 'type': 'ACTUAL'}}
Updated at
2024-02-28

1 organization

2 products

2 indications

Organization
Children's Hospital of Fudan University
Product
Individualized oral morphine
Indication
Tonsillectomy
Indication
Analgesic
Product
Morphine