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

Fujian Provincial Hospital

Status and phase: Enrolling; Phase 4

Conditions: Behavior Problem

Treatments: Drug: normal saline; Drug: Esketamine hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT06579937

K2023-02-005

Details and patient eligibility

About

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

Full description

Approximately half of children who undergo general anesthesia experience emergence delirium (ED) and postoperative negative behavioral changes (PNBC). There was a positive correlation between delirium during recovery and the change in negative behaviour after the operation.

Esketamine has sedative, analgesic and anti-traumatic stress effects. Based on literature analysis and preliminary trials, this study suggests that intraoperative use of low-dose esketamine may reduce the incidence of emergence delirium and postoperative negative behavior changes in children.

This prospective randomized controlled trial was conducted to compare the effect of intravenous esketamine in the incidence of emergence delirium and postoperative negative behavior changes in children compared to placebo (a look-alike substance that contains no drug) to provide a reference for optimizing clinical anesthesia medication regimens.

Enrollment: 172 estimated patients

Sex: All

Ages: 3 to 7 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• American society of Aneshesiologists physical status I or II;
• Aged 3-7 years;
• Scheduled for elective tonsillectomy and (or) adenoidectomy.

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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172 participants in 2 patient groups, including a placebo group

Esketamine group

Experimental group

Description:

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

Treatment:

Drug: Esketamine hydrochloride

Control group

Placebo Comparator group

Description:

During anesthesia induction, an equal volume of 0.9% saline was administered intravenously.

Treatment:

Drug: normal saline