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Remimazolam for Sedation in Children's Medical Procedures
Study Summary
This trial will test how well remimazolam works in children undergoing medical procedures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2016 Phase 3 trial • 461 Patients • NCT02290873Trial Design
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Who is running the clinical trial?
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- I have airway issues that could complicate emergency breathing help.I am currently experiencing heart failure.I have an active muscle or nerve disease.I, and if applicable, my parent(s), agree to participate in the trial.I am a child aged 3 to 17, scheduled for a medical procedure not related to this trial.I am under 18, in Europe, and scheduled for a medically necessary procedure unrelated to the trial.I am using effective birth control as a sexually active woman who can have children.I have a facial structure that could make emergency breathing help difficult.I am not taking any medications that are not allowed in the study.You have experienced unusual or unexpected reactions to benzodiazepines.I need a procedure that involves inserting a tube for breathing.I have been diagnosed with sleep apnea.I am currently experiencing severe breathing problems.I have not had any emergency medical procedures recently.I am currently experiencing liver failure.My procedure is planned to last no more than 2 hours.My overall health is good to moderately impaired.I will breathe on my own during sedation.
- Group 1: All Patients
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How can I enroll in the clinical research?
"This study needs 100 young participants, 17 years old or younger, who currently have all pediatric. Furthermore, it is essential that potential participants also meet the following requirements: For US patients: Male or female patients, aged 3 to <18 years, who are scheduled to undergo a diagnostic or therapeutic procedure, which is medically indicated and independent from the trial. For European patients: Male or female patients, aged full term birth to <18 years, who are scheduled to undergo a diagnostic or therapeutic procedure, which is medically indicated and independent from the trial. A female who is of child bearing potential (i.e. after menarche) and"
Does the age limit for this trial include people over 75 years old?
"This particular clinical trial is testing the experimental medication on patients that are below the age of 18."
In how many different geographical areas is this medical study being run today?
"Right now, this trial has 6 sites where patients can enroll. The sites are in Pittsburgh, Palo Alto, Sacramento, and 6 other locations. If you want to participate in the study, try to choose the location that is closest to you so that you won't have to travel too much."
What other research studies have included Remimazolam as a variable?
"Remimazolam was first studied in 2020 at Tianjin NanKai hospital. As of now, there have been a total of 37 completed studies. Currently, there are 14 live clinical trials, with a large portion of these taking place in Pittsburgh, Pennsylvania."
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