Clinical trial NCT06579937: Effects of Esketamine on Postoperative Behavioral Changes in Children Undergoing Tonsillectomy and/or Adenoidectomy
Official title: Esketamine for the Prevention of Postoperative Behavioral Changes in Children Undergoing Tonsillectomy and/or Adenoidectomy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Behavior Problem
Keywords: esketamine
postoperative negative behavioral change
pediatrics
emergence delirium
tonsillectomy
adenoidectomy
Lead sponsor: Fujian Provincial Hospital
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 172
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of postoperative negative behavior changes
timeFrame: Postoperative day 7
Secondary outcomes:
measure: Incidence of postoperative negative behavior changes
timeFrame: Postoperative day 1
measure: Incidence of emergence delirium
timeFrame: Within 30 minutes after extubation
measure: Incidence of postoperative negative behavior changes
timeFrame: Postoperative day 30
measure: Postoperative pain intensity
timeFrame: Within 30 minutes after extubation
measure: Preoperative anxiety
timeFrame: Before the intervention in holding area
measure: Emergence time
timeFrame: About up to 30 minutes postoperatively
measure: Parental satisfaction
timeFrame: Postoperative day 1
measure: Length of postanesthesia care unit stay
timeFrame: Up to 60 minutes postoperatively
measure: Incidence of adverse events
timeFrame: Up to 24 hours postoperatively
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
Study officials:
affiliation: Fujian Provincial Hospital
name: Xiaochun Zheng, MD
role: STUDY_CHAIR
References: