Intranasal Dexmedetomidine Versus Oral Midazolam Premedication for Postoperative Negative Behavior Changes in Children: 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 dexmedetomidine premedication in postoperative negative behavior changes in children compared to midazolam premedication. It will also learn about the effect of dexmedetomidine and midazolam in emergence delirium. The main questions are: * Dose dexmedetomidine lower the incidence of postoperative negative behavior changes compared to midazolam? * Dose dexmedetomidine lower the incidence of emergence delirium compared to midazolam? Researchers will compare dexmedetomidine to midazolam (a common pediatric premedication) to see if dexmedetomidine works to treat postoperative negative behavior change and emergence delirium. Participants will: * Take intranasal dexmedetomidine or oral midazolam or placebo (a look-alike substance that contains no drug) premedication * Fill in the Post hospitalization behavior questionnaire for ambulatory surgery postoperative 1, 3, 7, and 30

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 5
Healthy Volunteers: f
View:

• ASA physical status I or II;

• Aged 2-5 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@126.com
+86-13559939629
Backup
Sisi Chen, MD
chensisi49@163.com
+86-15080109541
Time Frame
Start Date: 2024-05-22
Estimated Completion Date: 2025-06-22
Participants
Target number of participants: 324
Treatments
Experimental: Dexmedetomidine group
Participants were premedicated with intranasal dexmedetomidine 2 μg/kg and oral sweet solution 0.25 mL/kg.
Active_comparator: Midazolam group
Participants were premedicated with intranasal 0.9% saline 0.02 mL/kg and oral midazolam 0.5 mg/kg.
Placebo_comparator: Placebo group
Participants were premedicated with intranasal 0.9% saline 0.02 mL/kg and oral sweet solution 0.25 mL/kg.
Related Therapeutic Areas
Sponsors
Leads: Fujian Provincial Hospital
Collaborators: Fujian Children's Hospital, Fujian Maternity and Child Health Hospital

This content was sourced from clinicaltrials.gov