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

NCT06579937 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2024-10-01

No results posted yet for this study

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

Conditions

  • Behavior Problem

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.

Sponsors & Collaborators

  • Fujian Provincial Hospital

    lead OTHER

Principal Investigators

  • Xiaochun Zheng, MD · Fujian Provincial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-02
Primary Completion
2025-09-30
Completion
2025-10-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06579937 on ClinicalTrials.gov