a Phase III Trial of Safety and Efficacy of Premedication With Dexmedetomidine and Midazolam in Pediatric Patients

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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 of treatment arms.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: King Faisal Specialist Hospital & Research Center
• Treatments: Dexmedetomidine; Midazolam

Criteria

Inclusion Criteria:

• All pediatric outpatients coming for MRI investigations requiring general anesthesia at King Faisal Specialist Hospital & Research Center (KFSH&RC) age 1-12 years

Exclusion Criteria:

• Weight ≥ 40 kilograms

• Allergies to the study drug

• Refused to take the study drug

• Severe learning disability

• Patient on Digoxin medication

• Cardiac disease with abnormal conduction system

• Nasal anatomical abnormality