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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 7
Healthy Volunteers: f
View:

• American society of Aneshesiologists physical status I or II;

• Aged 3-7 years;

• Scheduled for elective tonsillectomy and (or) adenoidectomy.

Locations
Other Locations
China
Fujian Provincial Hospital
RECRUITING
Fuzhou
Contact Information
Primary
Yusheng Yao, MD&PhD
fjslyys@fjmu.edu.cn
13559939629
Backup
Sisi Chen, MD
chensisi49@163.com
15080109541
Time Frame
Start Date: 2024-09-02
Estimated Completion Date: 2025-10-30
Participants
Target number of participants: 172
Treatments
Experimental: Esketamine group
During anesthesia induction, 0.2 mg/kg esketamine was administered intravenously.
Placebo_comparator: Control group
During anesthesia induction, an equal volume of 0.9% saline was administered intravenously.
Related Therapeutic Areas
Sponsors
Leads: Fujian Provincial Hospital

This content was sourced from clinicaltrials.gov