Intranasal Dexmedetomidine Versus Oral Midazolam Premedication for Postoperative Negative Behavior Changes in Children

Launched by FUJIAN PROVINCIAL HOSPITAL · May 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how well two medications, dexmedetomidine and midazolam, help prevent negative behavior changes in children after surgery. Specifically, the researchers want to see if dexmedetomidine can reduce the chances of children experiencing issues like confusion or agitation when they wake up from anesthesia compared to midazolam, a commonly used medication for children before surgery. Children aged 2 to 5 years who are scheduled for elective surgery, such as tonsil or adenoid removal, may be eligible to participate.

If your child joins the trial, they will receive either intranasal dexmedetomidine, oral midazolam, or a placebo (a harmless look-alike substance). After surgery, parents will fill out a questionnaire about their child's behavior at different times to help researchers understand how well each medication works. It's important to note that certain children may not be able to participate, such as those with specific medical conditions or recent major life changes. The trial is currently recruiting participants and aims to provide valuable insights into how these medications affect children's recovery after surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. ASA physical status I or II;
• • 2. Aged 2-5 years;
• • 3. Scheduled for elective tonsillectomy and (or) adenoidectomy.
• Exclusion Criteria:
• • 1. Parents refusing to allow their children to participate;
• • 2. Intake of sedative or analgesic medication within 48 hours before surgery;
• • 3. Developmental delay;
• • 4. Psychosis;
• • 5. Body mass index \> 30 kg/m2;
• • 6. Allergy to study drugs;
• • 7. 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.;
• • 8. Any other conditions that precluded study inclusion.