NCT04356638

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

A Partially Double-Blinded, Randomized, Controlled, Placebo-Controlled Study, a Phase III Trial of Safety and Efficacy of Premedication With Dexmedetomidine and Midazolam in Pediatric Patients

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: King Faisal Specialist Hospital & Research Center · Academic / Other
• Sex: All
• Age: 12 Months – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anxiety State
• Perioperative/Postoperative Complications

Interventions

Type	Name	Description
DRUG	Midazolam	Oral Midazolam and intranasal placebo
DRUG	Dexmedetomidine	Intranasal Dexmedetomidine and oral placebo
OTHER	Placebo	Placebo orally and intranasally

Timeline

• Start date: 2021-10-17
• Primary completion: 2023-12-30
• Completion: 2023-12-30
• First posted: 2020-04-22
• Last updated: 2023-11-24

Locations

1 site across 1 country: Saudi Arabia