Intranasal Midazolam for Pediatric Pre-procedural Sedation and Pre-procedural Anti-anxiety Using sipNose Device - a Randomized Controlled Study
NCT ID: NCT03635398
Last Updated: 2018-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
300 participants
INTERVENTIONAL
2018-08-31
2020-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Intranasal Midazolam in Children as a Pre-Operative Sedative - Part 2
NCT02356705
Intranasal Ketamine for Anxiolysis in Pediatric Emergency Department Patients
NCT03043430
Buccal Midazolam Versus Nasal or Oral Midazolam Sedation for Minor Invasive Procedures in Children
NCT02408302
Evaluation of Pediatric Procedural Sedation With Rectal Chloral Hydrate or Intranasal Midazolam
NCT01402596
Clinical Trial of Oral Midazolam in Pediatric Endoscopy
NCT00636428
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intranasal Midazolam by SipNose device
Sipnose device
SipNose's intranasal drug delivery platform uses an innovative mechanism that is suposed to improves efficacy, patient compliance and safety
Intranasal Midazolam by MAD (Mucosal Atomization Device)
MAD (Mucosal Atomization Device)
MAD (Mucosal Atomization Device)
oral administration of midazolam
midazolam
oral administration of midazolam
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sipnose device
SipNose's intranasal drug delivery platform uses an innovative mechanism that is suposed to improves efficacy, patient compliance and safety
MAD (Mucosal Atomization Device)
MAD (Mucosal Atomization Device)
midazolam
oral administration of midazolam
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Active respiratory infection
* systemic illness
* Allergy to Midazolam
1 Year
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
SipNose
UNKNOWN
Rabin Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Schneider Children's Medical Center of Israel
Petah Tikva, , Israel
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RMC-17-0435
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.