Effects of Esketamine on Postoperative Behavioral Changes in Children Undergoing Tonsillectomy and/or Adenoidectomy
Esketamine for the Prevention of Postoperative Behavioral Changes in Children Undergoing Tonsillectomy and/or Adenoidectomy: a Randomized Controlled Trial
Fujian Provincial Hospital
172 participants
Sep 2, 2024
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria3
- American society of Aneshesiologists physical status I or II;
- Aged 3-7 years;
- Scheduled for elective tonsillectomy and (or) adenoidectomy.
Exclusion Criteria8
- 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.
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Interventions
During anesthesia induction, a 0.2 mg/kg esketamine bolus was administered intravenously.
During anesthesia induction, a bolus of equal 0.9% saline was administered intravenously.
Locations(1)
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NCT06579937