Status:
COMPLETED
Midazolam Sedation in Dentally Anxious Patients
Lead Sponsor:
University Hospital, Clermont-Ferrand
Conditions:
Dental Anxiety
Eligibility:
All Genders
8-60 years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- \- 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
- \- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT01874717
Start Date
June 1 2005
End Date
August 1 2007
Last Update
June 11 2013
Active Locations (1)
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1
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003