Clinical trial

Median Effective Dose (ED50) of Esketamine Combined With Alfentanil for Children to Inhibit Body Movement During Laser Treatment for Facial Lesion

Name
XJA-20240224
Description
There is limited research on the combined use of esketamine and alfentanil for anesthesia during facial laser treatment in pediatric patients, and the effective dosage of esketamine for inhibiting body movement remains unclear. We explore the effective dose of esketamine combined with alfentanil for the inhibition of body movement during facial laser treatment in pediatric patients.
Trial arms
Trial start
2024-03-27
Estimated PCD
2025-03-27
Trial end
2025-04-27
Status
Not yet recruiting
Treatment
Esketamine
esketamine will be given intravenously
Arms:
esketamine
Other names:
intravenous esketamine
Size
40
Primary endpoint
half effective dose of inhibition of body movement
from injection of esketamine to start of laser treatment, in an average of 5 minutes
Eligibility criteria
Inclusion Criteria: * age between 3 years and 12 years old * patients scheduled for laser treatment of facial lesion Exclusion Criteria: * patients with airway infection during the last 1 month * patients with cardiac or pulmonary disorder * patients with hepatic or renal disfunction * patients with neurologic or psychiatric disorder
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'The Biased coin method is used', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Esketamine will be prepared by an investigator who is not involved in anesthesia and outcome assessment. For all participants, esketamine will be diluted to the same volume.'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2024-03-05

1 organization

1 product

1 indication

Product
Esketamine
Indication
Anesthesia