Status:
RECRUITING
Effects of Esketamine on Postoperative Behavioral Changes in Children Undergoing Tonsillectomy and/or Adenoidectomy
Lead Sponsor:
Fujian Provincial Hospital
Conditions:
Behavior Problem
Eligibility:
All Genders
3-7 years
Phase:
PHASE4
Brief Summary
The goal of this clinical trial is to learn the effect of intravenous esketamine in postoperative negative behavior changes in children compared to placebo (a look-alike substance that contains no dru...
Detailed Description
Approximately half of children who undergo general anesthesia experience emergence delirium (ED) and postoperative negative behavioral changes (PNBC). There was a positive correlation between delirium...
Eligibility Criteria
Inclusion
- American society of Aneshesiologists physical status I or II;
- Aged 3-7 years;
- Scheduled for elective tonsillectomy and (or) adenoidectomy.
Exclusion
- Parents refusing to allow their children to participate;
- Intake of sedative or analgesic medication within 48 hours before surgery;
- Developmental delay;
- Psychosis;
- Body mass index \> 30 kg/m2;
- Allergy to study drugs;
- Major life changes 1 month before the operation, such as the divorce of parents, death of parents, moving to a new home, changing to a new kindergarten, etc.;
- Any other conditions that precluded study inclusion.
Key Trial Info
Start Date :
September 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2025
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT06579937
Start Date
September 2 2024
End Date
October 30 2025
Last Update
October 1 2024
Active Locations (1)
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1
Fujian Provincial Hospital
Fuzhou, Fujian, China, 350001