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

• Status: Unknown status
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Carmel Medical Center
• Treatments: Midazolam

Criteria

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.