Clinical Trial

Effects of Esketamine on Postoperative Behavioral Changes in Children Undergoing Tonsillectomy and/or Adenoidectomy

Recruiting Phase 4
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Record status
This record was last updated October 1, 2024 (before its estimated September 30, 2025 completion). Its status may not reflect the trial's current state.
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
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-08-29; most recent amendment 2024-09-27.
Status change: Not Yet Recruiting → Recruiting 2024-09-27
Trial Details
NCT Number NCT06579937
Lead Sponsor Fujian Provincial Hospital
Conditions Behavior Problem
Enrollment 172 participants
Start Date 2024-09-02
Primary Completion 2025-09-30 (estimated)
Study Completion 2025-10-30 (estimated)
Updated on ClinicalTrials.gov 2024-10-01