Comparing dexmedetomidine and midazolam for reducing negative behavior in children after surgery
Intranasal Dexmedetomidine Versus Oral Midazolam Premedication for Postoperative Negative Behavior Changes in Children: A Randomized Controlled Trial
This study is testing if a nasal spray called dexmedetomidine can help young children have less negative behavior after surgery compared to a common medicine called midazolam.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 324 (estimated) |
| Ages | 2 Years to 5 Years |
| Sex | All |
| Sponsor | Fujian Provincial Hospital Academic / other |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT06417125 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of intranasal dexmedetomidine compared to oral midazolam in reducing postoperative negative behavior changes and emergence delirium in children aged 2-5 years undergoing elective tonsillectomy or adenoidectomy. Participants will receive either dexmedetomidine, midazolam, or a placebo before surgery and will be assessed for behavioral changes postoperatively using a questionnaire at multiple time points. The study seeks to determine if dexmedetomidine can lower the incidence of these negative outcomes compared to the standard treatment with midazolam.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 2-5 years who are scheduled for elective tonsillectomy or adenoidectomy and have an ASA physical status of I or II.
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 provide a safer and more effective premedication option for children undergoing surgery, reducing the risk of postoperative behavioral issues.
How similar studies have performed: Previous studies have indicated that dexmedetomidine may reduce emergence delirium compared to midazolam, suggesting potential success for this comparative approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Fuzhou, Fujian
- Fujian Provincial Hospital — Fuzhou, Fujian, China (Recruiting)
Study contacts
- Study coordinator: Yusheng Yao, MD&PhD
- Email: fjslyys@126.com
- Phone: +86-13559939629
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.