Intranasal Midazolam for Pediatric Pre-procedural Sedation and Pre-procedural Anti-anxiety Using sipNose Device - a Randomized Controlled Study
1 other identifier
interventional
300
1 country
1
Brief Summary
A Three-arm, Randomized Controlled Trial for Pediatric Pre-procedural Sedation and Pre-procedural Anti-anxiety: Intranasal Midazolam by SipNose versus MAD Versus oral administration
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2018
CompletedFirst Submitted
Initial submission to the registry
August 15, 2018
CompletedFirst Posted
Study publicly available on registry
August 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedAugust 17, 2018
August 1, 2018
1.9 years
August 15, 2018
August 16, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Anexiety level
measured by modified PREOPERATIVE ANXIETY SCALE (YALE)
within 60 minute
Sedation level
measured by RAMSAY SEDATION SCALE
within 60 minute
Study Arms (3)
Intranasal Midazolam by SipNose device
EXPERIMENTALIntranasal Midazolam by MAD (Mucosal Atomization Device)
ACTIVE COMPARATORoral administration of midazolam
ACTIVE COMPARATORInterventions
SipNose's intranasal drug delivery platform uses an innovative mechanism that is suposed to improves efficacy, patient compliance and safety
MAD (Mucosal Atomization Device)
Eligibility Criteria
You may qualify if:
- every child \>1y who is intended for medical procedure in the emrgency room(suce as: IV insertion, blood sample collection, urinary catether insertion, laceration repair
You may not qualify if:
- ASA\>2
- Active respiratory infection
- systemic illness
- Allergy to Midazolam
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rabin Medical Centerlead
- SipNosecollaborator
Study Sites (1)
Schneider Children's Medical Center of Israel
Petah Tikva, 49202, Israel
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2018
First Posted
August 17, 2018
Study Start
August 1, 2018
Primary Completion
July 1, 2020
Study Completion
July 1, 2020
Last Updated
August 17, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share
Because of commercial confidentially the study database will not become public within the first 3 years since the begining of the study