Midazolam Sedation in Dentally Anxious Patients

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Use lay language.

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Clermont-Ferrand
• Treatments: Midazolam

Criteria

Inclusion Criteria:

• - Patient between 8 and 60 years, regardless of gender

• Patient in the American Society of Anesthesiologists (ASA) category I ou II.

• Patient in need of multiple dental care, referred to the Unit of Special Care Dentistry for cooperation difficulties

• Patients directed to conscious sedation under midazolam because they cannot be approached for more than a very brief examination, or following failure to treat under inhalation sedation (50% N2O/O2), or following poor cooperation during treatment under inhalation sedation (poor cooperation is defined as a score of 3 or more on the French modified version of the Venham scale), or following good cooperation during short and simple treatment under inhalation sedation but in need of more complex rehabilitation.

• Written consent signed by the patient or his legal guardian

• Patient accompanied by an accountable person

Exclusion Criteria:

• - Patient below 8 years or over 60 years-old

• Patient in the American Society of Anesthesiologists (ASA) category III or more

• Patient having accepted dental treatment without premedication or sedation, and without declaring dental anxiety, during the month prior to the appointment

• Patient having received an anxiolytic premedication in the 24 hours preceding the dental care session

• Patient already treated under midazolam sedation less than a week ago

• Any medical contraindication to the use of midazolam