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

Not Applicable

• Conditions: Procedural Sedation; Intra-nasal Delevery Device
• Interventions: Drug: midazolam; Device: MAD (Mucosal Atomization Device); Device: Sipnose device

• Registration Number: NCT03635398
• Lead Sponsor: Rabin Medical Center

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-08
• Study Start: 2018-08
• Study First Submitted: 2018-08-15
• Study First Submitted QC: 2018-08-16
• Last Update Submitted: 2018-08-16
• Study First Posted: 2018-08-17
• Last Update Posted: 2018-08-17
• Primary Completion: 2020-07
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oral administration of midazolam	midazolam	-
Intranasal Midazolam by MAD (Mucosal Atomization Device)	MAD (Mucosal Atomization Device)	-
Intranasal Midazolam by SipNose device	Sipnose device	-

Primary Outcome Measures

Name	Time	Method
Sedation level	within 60 minute	measured by RAMSAY SEDATION SCALE
Anexiety level	within 60 minute	measured by modified PREOPERATIVE ANXIETY SCALE (YALE)

Trial Locations

Locations (1)

Schneider Children's Medical Center of Israel; 🇮🇱 Petach Tikva, Israel