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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age3-7
SponsorFujian Provincial Hospital

About this trial

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

Eligibility criteria

Qualifiers

American society of Aneshesiologists physical status I or II;

Aged 3-7 years;

Scheduled for elective tonsillectomy and (or) adenoidectomy.

Disqualifiers

Parents refusing to allow their children to participate;

Intake of sedative or analgesic medication within 48 hours before surgery;

Developmental delay;

Psychosis;

Trial design

Treatments tested in this trial

  • Esketamine hydrochloride
  • normal saline

Treatment groups

172 Participants
are divided into 2 treatment groups

Sponsors and collaborators