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ED50 of Esketamine for Laser Treatment in Children

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06294639
Acronym
ESCALATE
Enrollment
40
Registered
2024-03-05
Start date
2024-03-27
Completion date
2025-04-27
Last updated
2024-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

esketamine, children, half effective dose, laser treatment

Brief summary

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.

Interventions

DRUGEsketamine

esketamine will be given intravenously

Sponsors

Air Force Military Medical University, China
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE

Masking description

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.

Intervention model description

The Biased coin method is used

Eligibility

Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
half effective dose of inhibition of body movementfrom injection of esketamine to start of laser treatment, in an average of 5 minutes

Secondary

MeasureTime frameDescription
number of patients with agitation during awakefrom end of injection of esketamine to 30 minutes after laser treatment, in an average of 60 minutes
number of patients with dizzy during awakefrom end of injection of esketamine to 30 minutes after laser treatment, in an average of 60 minutes
number of patients with nausea and vomiting during awakefrom end of injection of esketamine to 30 minutes after laser treatment, in an average of 60 minutes
number of patients with apnea during awakefrom end of injection of esketamine to 30 minutes after laser treatment, in an average of 60 minutes
satisfaction score of the parents to the anesthesiafrom end of laser treatment to discharge from the outpatient unit, in an average of 60 minutesThe satisfaction of the parents to the anesthesia will be assessed by visual analogue scale, of which 0 is for extremely not satisfied, 10 is for extremely satisfied

Contacts

Primary ContactZhi-Hong Lu
deerlu23@163.com+862984775343

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026