Intranasal Midazolam for Pediatric Pre-procedural Sedation and Pre-procedural Anti-anxiety Using sipNose Device - a Randomized Controlled Study

Procedural Sedation Clinical Trial

Official title:

Intranasal Midazolam for Pediatric Pre-procedural Sedation and Pre-procedural Anti-anxiety Using sipNose Device - a Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03635398
• Other study ID #: RMC-17-0435
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2018
• Est. completion date: July 2020

Study information

• Verified date: August 2018
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• ASA>2

• Active respiratory infection

• systemic illness

• Allergy to Midazolam

Related Conditions & MeSH terms

• Intra-nasal Delevery Device
• Procedural Sedation

Intervention

Device:
• 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)

Drug:
• midazolam
oral administration of midazolam

Locations

Country	Name	City	State
Israel	Schneider Children's Medical Center of Israel	Petach Tikva

Sponsors (2)

Lead Sponsor	Collaborator
Rabin Medical Center	SipNose

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anexiety level	measured by modified PREOPERATIVE ANXIETY SCALE (YALE)	within 60 minute
Primary	Sedation level	measured by RAMSAY SEDATION SCALE	within 60 minute