UnknownPhase 3

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

Saudi Arabia80 participantsStarted 2021-10-17

Plain-language 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.

Who can participate

Age range

12 Months – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Anxiety Level

Timeframe: 30 Minutes

Safety - Hemodynamic stability

Timeframe: 30 Minutes

Safety - Respiratory function

Timeframe: 30 Minutes

Oxygen saturation

Timeframe: 30 Minutes

Trial details

NCT IDNCT04356638

SponsorKing Faisal Specialist Hospital & Research Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-30

Contact for this trial

Lars Engborg, MD

+966555327987 lengborg@kfshrc.edu.sa

View on ClinicalTrials.gov More Anxiety State trials

Who can participate

Age range

12 Months – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.