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RECRUITING
NCT06579937
PHASE4

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

Sponsor: Fujian Provincial Hospital

View on ClinicalTrials.gov

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

Interventions

DRUG

Esketamine hydrochloride

During anesthesia induction, a 0.2 mg/kg esketamine bolus was administered intravenously.

DRUG

normal saline

During anesthesia induction, a bolus of equal 0.9% saline was administered intravenously.

Locations (1)

Fujian Provincial Hospital

Fuzhou, Fujian, China