Effects of Esketamine on Postoperative Behavioral Changes in Children Undergoing Tonsillectomy and Adenoidectomy
NCT Number: NCT06579937
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Behavior Problem
Interventions: DRUG: Esketamine hydrochloride|DRUG: normal saline
Sponsor: Fujian Provincial Hospital
Sex: ALL
Age: CHILD
Enrollment: 228
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-09-02
Completion Date: 2025-10-30
Locations: Fujian Provincial Hospital, Fuzhou, Fujian, 350000, China

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

Primary Outcome Measures: Incidence of postoperative negative behavior changes, Postoperative negative behavior changes were assessed with Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS)., Postoperative day 7
Secondary Outcome Measures: Incidence of postoperative negative behavior changes, Postoperative negative behavior changes were assessed with Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS)., Postoperative day 1|Incidence of emergence delirium, Emergence delirium was assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale (defined as a PAED score of ≥10)., Within 30 minutes after extubation|Incidence of postoperative negative behavior changes, Postoperative negative behavior changes were assessed with Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS)., Postoperative day 30|Postoperative pain intensity, Postoperative pain intensity will be measured using the face, legs, activity, cry, and consolability scale., Within 30 minutes after extubation|Preoperative anxiety, Preoperative anxiety will be assessed using the modified Yale preoperative anxiety scale. Scores range from 23 to 100 with higher scores indicating greater anxiety., Before the intervention in holding area|Emergence time, Emergence time is defined as the interval from discontinuation of inhalation anesthetic to eye-opening on verbal command., About up to 30 minutes postoperatively|Parental satisfaction, 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)., Postoperative day 1|Length of postanesthesia care unit stay, 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)., Up to 60 minutes postoperatively|Incidence of adverse events, Adverse events such as bradycardia, tachycardia, hypertension, hypotension, and hypoxia will be recorded during the trial., Up to 24 hours postoperatively