Effects of esketamine on children's behavior after tonsil or adenoid surgery
Esketamine for the Prevention of Postoperative Behavioral Changes in Children Undergoing Tonsillectomy and/or Adenoidectomy: a Randomized Controlled Trial
This study is testing if giving esketamine to young children during tonsil or adenoid surgery can help reduce behavioral issues after the surgery compared to a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 172 (estimated) |
| Ages | 3 Years to 7 Years |
| Sex | All |
| Sponsor | Fujian Provincial Hospital Academic / other |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT06579937 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the impact of intravenous esketamine on postoperative behavioral changes in children undergoing tonsillectomy and/or adenoidectomy. It compares the effects of esketamine against a placebo to determine if it can reduce the incidence of emergence delirium and negative behavioral changes following surgery. Participants aged 3-7 years will receive either esketamine or a placebo during anesthesia induction and will be assessed using a behavior questionnaire post-surgery. The study seeks to provide insights into optimizing anesthesia regimens for pediatric patients.
Who should consider this trial
Good fit: Ideal candidates are children aged 3-7 years scheduled for elective tonsillectomy and/or adenoidectomy.
Not a fit: Patients with developmental delays, psychosis, or significant recent life changes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative behavioral outcomes for children undergoing surgery.
How similar studies have performed: Previous studies have suggested potential benefits of esketamine in similar contexts, but this specific application is being explored in a novel way.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Fuzhou, Fujian
- Fujian Provincial Hospital — Fuzhou, Fujian, China (Recruiting)
Study contacts
- Study coordinator: Yusheng Yao, MD&PhD
- Email: fjslyys@fjmu.edu.cn
- Phone: 13559939629
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.