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

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Clalit Health Services

Status

Unknown

Conditions

Intra-nasal Delevery Device
Procedural Sedation

Treatments

Device: Sipnose device
Drug: midazolam
Device: MAD (Mucosal Atomization Device)

Study type

Interventional

Funder types

Other

Identifiers

NCT03635398
RMC-17-0435

Details and patient eligibility

About

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

Enrollment

300 estimated patients

Sex

All

Ages

1 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

300 participants in 3 patient groups

Intranasal Midazolam by SipNose device
Experimental group
Treatment:
Device: Sipnose device
Intranasal Midazolam by MAD (Mucosal Atomization Device)
Active Comparator group
Treatment:
Device: MAD (Mucosal Atomization Device)
oral administration of midazolam
Active Comparator group
Treatment:
Drug: midazolam

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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