Evaluating the safety and effectiveness of Dexmedetomidine and Midazolam for pediatric anesthesia
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
PHASE3 · King Faisal Specialist Hospital & Research Center · NCT04356638
This study is testing if the medications Dexmedetomidine and Midazolam are safe and effective for calming children aged 1 to 12 before they undergo MRI scans with general anesthesia.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 12 Months to 12 Years |
| Sex | All |
| Sponsor | King Faisal Specialist Hospital & Research Center (other) |
| Locations | 1 site (Riyadh) |
| Trial ID | NCT04356638 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety and efficacy of Dexmedetomidine and Midazolam as premedication in pediatric patients undergoing MRI procedures requiring general anesthesia. The study will compare these medications against the current standard of care at King Faisal Specialist Hospital & Research Center. It will evaluate the frequency of adverse effects and overall treatment outcomes in children aged 1 to 12 years. The trial is interventional and will involve administering either the study drugs or a placebo to the participants.
Who should consider this trial
Good fit: Ideal candidates for this study are pediatric outpatients aged 1-12 years who require general anesthesia for MRI investigations.
Not a fit: Patients who weigh 40 kilograms or more or have specific medical conditions such as cardiac disease or severe learning disabilities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved anesthesia management and reduced anxiety for pediatric patients undergoing procedures.
How similar studies have performed: Other studies have shown promising results with similar approaches in pediatric anesthesia, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Riyadh
- King Faisal Specialist Hospital & Research Center — Riyadh, Saudi Arabia (RECRUITING)
Study contacts
- Principal investigator: Ganesh Sivasankara, MBBS — King Faisal Specialist Hospital & Research Center
- Study coordinator: Lars Engborg, MD
- Email: lengborg@kfshrc.edu.sa
- Phone: +966555327987
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anxiety State, Perioperative/Postoperative Complications