Midazolam Sedation in Dentally Anxious Patients

University Hospital, Clermont-Ferrand

Status and phase: Completed; Phase 3

Conditions: Dental Anxiety

Treatments: Drug: midazolam; Other: Conscious sedation for dental care

Study type: Interventional

Funder types: Other

Identifiers

NCT01874717

CHU-0155

Details and patient eligibility

About

Use lay language.

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

Full 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.

Enrollment: 131 patients

Sex: All

Ages: 8 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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131 participants in 2 patient groups

oral midazolam

Experimental group

Description:

oral administration of midazolam : the dose administered is twice the individual dose determined in session 1.

Treatment:

Drug: midazolam

Other: Conscious sedation for dental care

intravenous midazolam

Other group

Description:

intravenous administration of midazolam at the individual dose determined in session 1

Treatment:

Drug: midazolam

Other: Conscious sedation for dental care