Buccal Midazolam Versus Nasal or Oral Midazolam Sedation for Minor Invasive Procedures in Children

Israel Healthcare Foundation

Status and phase

Unknown

Phase 4

Conditions

Dormicum

Conscious Sedation

Children

Treatments

Drug: Midazolam

Study type

Interventional

Funder types

Other

Identifiers

NCT02408302

CMC-13-0075-CTIL

Details and patient eligibility

About

Currently Midazolam sedation is the standard of care for minor invasive procedures in pediatric patients; its use is restricted to two routes of administration for this purpose oral and intranasal.

A third route of administration (buccal) is tested and approved for seizure management. In the investigators' study the researchers investigate the buccal route of administration versus oral or intranasal administration for sedation. The investigators' hypothesis is that buccal route of administration is more convenient than intranasal and better absorbed than oral.

Enrollment

90 estimated patients

Sex

All

Ages

5 months to 6 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

age 5 months to 6 years.
need to undergo a minimal invasive procedure that requires light sedation.
ASA (American Society of Anesthesiologists) I-II
parent that can read, understand and sign an informed consent form

Exclusion criteria

patients with life threatening conditions.
patients with respiratory or cardiac chronic illnesses or ASA other than I-II.
patients with traumatic injury for the nose or the oral cavity.
patients that would not or cannot take the drug in the route picked in a randomized way.