Midazolam Sedation in Dentally Anxious Patients

Dental Anxiety Clinical Trial

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

Status Completed

Clinical Trial Summary

Use lay language.

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

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Anxiety

• NCT number: NCT01874717
• Study type: Interventional
• Source: University Hospital, Clermont-Ferrand
• Status: Completed
• Phase: Phase 3
• Start date: June 2005
• Completion date: August 2007