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
American society of Aneshesiologists physical status I or II;
Aged 3-7 years;
Scheduled for elective tonsillectomy and (or) adenoidectomy.
Parents refusing to allow their children to participate;
Intake of sedative or analgesic medication within 48 hours before surgery;
Developmental delay;
Psychosis;
Parallel
Esketamine hydrochloride
DrugDuring anesthesia induction, a 0.2 mg/kg esketamine bolus was administered intravenously.
normal saline
DrugDuring anesthesia induction, a bolus of equal 0.9% saline was administered intravenously.
Incidence of postoperative negative behavior changes
Postoperative negative behavior changes were assessed with Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).
Incidence of postoperative negative behavior changes
Postoperative negative behavior changes were assessed with Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).
Incidence of emergence delirium
Emergence delirium was assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale (defined as a PAED score of ≥10).
Incidence of postoperative negative behavior changes
Postoperative negative behavior changes were assessed with Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).
Postoperative pain intensity
Postoperative pain intensity will be measured using the face, legs, activity, cry, and consolability scale.
Click on the lead sponsor to view all of their trials.
