Actively Recruiting
Effects of Esketamine on Postoperative Behavioral Changes in Children Undergoing Tonsillectomy and/or Adenoidectomy
Led by Fujian Provincial Hospital · Updated on 2024-10-01
172
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 drug). It will also learn about the effect of esketamine in emergence delirium. The main questions are: Dose esketamine lower the incidence of postoperative negative behavior changes compared to placebo? Dose esketamine lower the incidence of emergence delirium compared to placebo? Researchers will compare esketamine to placebo to see if esketamine works to treat postoperative negative behavior change and emergence delirium. Participants will: Receive intravenous esketamine or placebo (a look-alike substance that contains no drug) during anesthesia induction; Fill in the Post hospitalization behavior questionnaire for ambulatory surgery postoperative 1, 7, and 30
CONDITIONS
Official Title
Effects of Esketamine on Postoperative Behavioral Changes in Children Undergoing Tonsillectomy and/or Adenoidectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- American Society of Anesthesiologists physical status I or II
- Aged 3 to 7 years
- Scheduled for elective tonsillectomy and/or adenoidectomy
You will not qualify if you...
- Parents refusing to allow their children to participate
- Use of sedative or analgesic medication within 48 hours before surgery
- Developmental delay
- Psychosis
- Body mass index greater than 30 kg/m2
- Allergy to study drugs
- Major life changes within 1 month before surgery (such as parents' divorce, death of parents, moving, or changing kindergarten)
- Any other conditions preventing study participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fujian Provincial Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
Research Team
Y
Yusheng Yao, MD&PhD
CONTACT
S
Sisi Chen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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