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NCT Number: NCT06579937

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

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

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Key information

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fujian Provincial Hospital

Fuzhou, Fujian, 350001, China

Location status: Recruiting

Location contact

Sisi Chen, MD

CONTACT

[email protected]

15080109541

Yusheng Yao, MD&PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Esketamine hydrochloride

Drug

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

Other names: esketamine hydrochloride injection

normal saline

Drug

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

Primary outcomes

  1. Incidence of postoperative negative behavior changes

    Time frame: Postoperative day 7

    Postoperative negative behavior changes were assessed with Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).

Secondary outcomes

  1. Incidence of postoperative negative behavior changes

    Time frame: Postoperative day 1

    Postoperative negative behavior changes were assessed with Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).

  2. Incidence of emergence delirium

    Time frame: Within 30 minutes after extubation

    Emergence delirium was assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale (defined as a PAED score of ≥10).

  3. Incidence of postoperative negative behavior changes

    Time frame: Postoperative day 30

    Postoperative negative behavior changes were assessed with Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).

  4. Postoperative pain intensity

    Time frame: Within 30 minutes after extubation

    Postoperative pain intensity will be measured using the face, legs, activity, cry, and consolability scale.

  5. Preoperative anxiety

    Time frame: Before the intervention in holding area

    Preoperative anxiety will be assessed using the modified Yale preoperative anxiety scale. Scores range from 23 to 100 with higher scores indicating greater anxiety.

  6. Emergence time

    Time frame: About up to 30 minutes postoperatively

    Emergence time is defined as the interval from discontinuation of inhalation anesthetic to eye-opening on verbal command.

  7. Parental satisfaction

    Time frame: Postoperative day 1

    Parental satisfaction is self-reported using a five-point Likert scale (5=very satisfied, 4=satisfied, 3=neither satisfied nor dissatisfied, 2=dissatisfied, and 1=very dissatisfied).

  8. Length of postanesthesia care unit stay

    Time frame: Up to 60 minutes postoperatively

    Length of postanesthesia care unit (PACU) stay is defined as the time between arrival in the PACU and readiness for discharge from the PACU (defined as a modified Aldrete score of ≥9).

  9. Incidence of adverse events

    Time frame: Up to 24 hours postoperatively

    Adverse events such as bradycardia, tachycardia, hypertension, hypotension, and hypoxia will be recorded during the trial.

Study contacts

Contact information is provided by the study sponsor or research team.

Sisi Chen, MD

CONTACT

[email protected]

15080109541

Yusheng Yao, MD&PhD

CONTACT

[email protected]

13559939629

Sponsors and collaborators

Lead sponsor

Fujian Provincial Hospital

Other

Registry information

Official study title

Esketamine for the Prevention of Postoperative Behavioral Changes in Children Undergoing Tonsillectomy and/or Adenoidectomy: a Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 30, 2024
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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