Intranasal Ketamine and Midazolam Mixture for Procedural Sedation in Children With Mental Disabil… (NCT03860831) | Clinical Trial Compass
UnknownPhase 1
Intranasal Ketamine and Midazolam Mixture for Procedural Sedation in Children With Mental Disabilities:
Egypt40 participantsStarted 2019-03-06
Plain-language summary
Ketamine and Midazolam are well known sedative drugs that can be given through different routes such as intravenous, intramuscular, oral, rectal and intranasal route. Anesthetic staff usually prefer intravenous route but sometimes inserting venous access is difficult in uncooperative mentally disabled children. Intranasal ketamine+Midazolam can be a needless effective alternative in these vulnerable patients
Who can participate
Age range
4 Years – 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:
* Inclusion criteria of the patients were:
* Mentally affected children (autism,down syndrome and cerebral palsy)
* children who are scheduled for Short procedures (30 minutes or less) under sedation
Exclusion Criteria:
* parents refusal.
* child cooperation and acceptance of venipuncture or cannula in situ.
* children with known allergy to ketamine or midazolam.
* liver or renal organ dysfunction.
* suspected difficult cannulation.
* congenital heart disease.
* active pulmonary infection or asthma.
* increased intracranial tension or intraocular pressure.
* severe trauma0
* significant nasal discharge or obstruction.
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
1
change in sedation level after intranasal or intramuscular ketamine midazolam mixture administration.
Timeframe: every 10 minutes through the study till one hour after administration