NCT01874717

Midazolam Sedation in Dentally Anxious Patients

Conscious Sedation With Midazolam in Dentally Anxious Patients: Effect of the Administration Route (Oral Versus Intravenous Administration)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 8 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Use lay language. To compare patient level of cooperation during dental care under conscious sedation with midazolam according to the administration route

Detailed description

The progress of the study is described below: Session 1: intravenous administration of midazolam. Establishment of the individual dose. Randomisation. Session 2 : Group A : oral administration of midazolam : the dose administered is twice the individual dose determined in session 1. Group B : intravenous administration of midazolam at the individual dose determined in session 1. Session 3 : reversal of the procedures : Group A : intravenous administration of midazolam at the individual dose determined in session 1. Group B : oral administration of midazolam : the dose administered is twice the individual dose determined in session 1.

Conditions

• Dental Anxiety

Interventions

Type	Name	Description
OTHER	Conscious sedation for dental care
DRUG	midazolam

Timeline

• Start date: 2005-06-01
• Primary completion: 2007-08-01
• Completion: 2007-08-01
• First posted: 2013-06-11
• Last updated: 2013-06-11

Locations

1 site across 1 country: France