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