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

Launched by KING FAISAL SPECIALIST HOSPITAL & RESEARCH CENTER · Apr 21, 2020

Keywords

ClinConnect Summary

This clinical trial is studying how well two medications, Dexmedetomidine and Midazolam, work to help children feel calm and safe before and during MRI scans that require general anesthesia. The goal is to see how effective these medications are compared to the usual treatment given at King Faisal Specialist Hospital & Research Center. Researchers will also look at how safe these medications are and if they cause any unwanted side effects.

To be eligible for this study, children aged 1 to 12 years who are scheduled for an MRI and need general anesthesia can participate. However, there are some exclusions, such as children who weigh 40 kilograms or more, have allergies to the medications, or have certain medical conditions. If your child participates, they will receive one of the medications before their MRI, and medical staff will monitor them closely throughout the process to ensure their safety. This trial is currently looking for participants, and it aims to improve care for young patients undergoing anesthesia.

Gender

ALL

Eligibility 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
• • Patient on beta-blocker medication
• • Cardiac disease with abnormal conduction system
• • Nasal anatomical abnormality