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Effects of Esketamine on Postoperative Behavioral Changes in Children Undergoing Tonsillectomy and/or Adenoidectomy
Sponsor: Fujian Provincial Hospital
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 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
Official title: Esketamine for the Prevention of Postoperative Behavioral Changes in Children Undergoing Tonsillectomy and/or Adenoidectomy: a Randomized Controlled Trial
Key Details
Gender
All
Age Range
3 Years - 7 Years
Study Type
INTERVENTIONAL
Enrollment
172
Start Date
2024-09-02
Completion Date
2025-10-30
Last Updated
2024-10-01
Healthy Volunteers
No
Conditions
Interventions
Esketamine hydrochloride
During anesthesia induction, a 0.2 mg/kg esketamine bolus was administered intravenously.
normal saline
During anesthesia induction, a bolus of equal 0.9% saline was administered intravenously.
Locations (1)
Fujian Provincial Hospital
Fuzhou, Fujian, China