Status:
NOT_YET_RECRUITING
Comparing Two Doses of Midazolam With Added Dexmedetomidine for Kids Before Surgery
Lead Sponsor:
Cairo University
Conditions:
Preoperative Anxiety Experienced by the Pediatric Patient
Preoperative Anxiety
Eligibility:
All Genders
1-8 years
Phase:
PHASE2
Brief Summary
The goal of this this randomized controlled trial is to investigate if adding intranasal dexmedetomidine to two different doses of intranasal midazolam provides effective sedation with fewer side effe...
Eligibility Criteria
Inclusion
- Pediatric patients aged 1 to 8 years
- Scheduled for elective surgery under general anesthesia
- Surgery duration \< 1 hour
- ASA physical status I or II
- Parent or legal guardian able to provide informed consent
Exclusion
- Refusal to participate by parent/guardian
- Nasal infections, pathology, or epistaxis
- Runny nose or upper respiratory tract infection
- Enlarged adenoids
- BMI \> 30
- Known allergy to dexmedetomidine or midazolam
- Fever on day of surgery
- Coagulopathy
- Scheduled for cardiothoracic or neurosurgical procedures
- Congenital heart disease
- Neurological or mental disorders
- Pre-existing sedation (MOASS \< 5) on the day of surgery
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06979791
Start Date
June 1 2025
End Date
December 1 2025
Last Update
May 20 2025
Active Locations (2)
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1
Kasr Al-Ainy Hospital, Cairo University
Cairo, Egypt, 11562
2
Souad Kafafi University Hospital, Misr University for Science and
Giza, Egypt