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

Launched by FUJIAN PROVINCIAL HOSPITAL · Aug 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how a medication called esketamine affects children's behavior after they have surgery to remove their tonsils and/or adenoids. The researchers want to find out if esketamine can help reduce negative behavior changes and a condition called emergence delirium, which can cause confusion and agitation as children wake up from anesthesia. To do this, some children will receive esketamine through an IV, while others will receive a placebo, which looks like the medication but has no active ingredients.

The trial is open to children aged 3 to 7 years who are in generally good health and scheduled for this type of surgery. Parents will need to fill out a behavior questionnaire about their child's mood and actions after the surgery at different times (1 day, 1 week, and 1 month later). It's important to note that children with certain conditions, such as those who have taken sedatives recently or have significant life changes, will not be eligible to participate. Overall, this study aims to help improve our understanding of how to support children’s recovery after surgery.

Gender

ALL

Eligibility 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.