Status:
UNKNOWN
a Phase III Trial of Safety and Efficacy of Premedication With Dexmedetomidine and Midazolam in Pediatric Patients
Lead Sponsor:
King Faisal Specialist Hospital & Research Center
Conditions:
Anxiety State
Perioperative/Postoperative Complications
Eligibility:
All Genders
12-12 years
Phase:
PHASE3
Brief Summary
This research study to evaluate the relative efficacy of Dexmedetomidine, Midazolam, and compare them to the current KFSH\&RC standard of care. Compare the safety and the frequency of adverse effects ...
Eligibility Criteria
Inclusion
- All pediatric outpatients coming for MRI investigations requiring general anesthesia at King Faisal Specialist Hospital \& Research Center (KFSH\&RC) age 1-12 years
Exclusion
- Weight ≥ 40 kilograms
- Allergies to the study drug
- Refused to take the study drug
- Severe learning disability
- Patient on Digoxin medication
- Patient on beta-blocker medication
- Cardiac disease with abnormal conduction system
- Nasal anatomical abnormality
Key Trial Info
Start Date :
October 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04356638
Start Date
October 17 2021
End Date
December 30 2023
Last Update
November 24 2023
Active Locations (1)
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1
King Faisal Specialist Hospital & Research Center
Riyadh, Saudi Arabia