NCT02408302

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

Buccal Midazolam Versus Nasal or Oral Midazolam Sedation for Minor Invasive Procedures in Children: A Prospective Randomized Control Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Carmel Medical Center · Academic / Other
• Sex: All
• Age: 5 Months – 6 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dormicum
• Conscious Sedation
• Children

Interventions

Type	Name	Description
DRUG	Midazolam	comparison between 3 routes of administration of the drug Midazolam used for sedation for minor procedures in pediatric population. the routes are oral intranasal and buccal.

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-02-01
• Completion: 2016-03-01
• First posted: 2015-04-03
• Last updated: 2015-04-09

Locations

1 site across 1 country: Israel