Midazolam Sedation in Dentally Anxious Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01874717
• Date of registration: 28/05/2013
• Prospective Registration: No
• Primary sponsor: University Hospital, Clermont-Ferrand
• Public title: Midazolam Sedation in Dentally Anxious Patients
• Scientific title: Conscious Sedation With Midazolam in Dentally Anxious Patients: Effect of the Administration Route (Oral Versus Intravenous Administration)
• Date of first enrolment: June 2005
• Target sample size: 131
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01874717
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Valérie COLLADO
• Affiliation: University Hospital, Clermont-Ferrand

Key inclusion & exclusion 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



Age minimum: 8 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Dental Anxiety

Intervention(s)

Drug: midazolam

Other: Conscious sedation for dental care

Primary Outcome(s)

Patient level of cooperation which is assessed using the French modified version of Venham scale [Time Frame: During the first dental care procedure (at day 1)]

Patient level of cooperation which is assessed using the French modified version of Venham scale [Time Frame: During the first injection of local anaesthesia (at day 1)]

Patient level of cooperation which is assessed using the French modified version of Venham scale [Time Frame: At the first contact with the dentist (at day 1)]

Patient level of cooperation which is assessed using the French modified version of Venham scale [Time Frame: During venous cannulation (at day 1)]

Secondary Outcome(s)

Satisfaction level of the operator which is assessed using the French modified version of Venham scale [Time Frame: 48 hours after dental care (T14).]

Satisfaction level of the patient which is assessed using the French modified version of Venham scale [Time Frame: 48 hours after dental care (T14).]

The level of patient stress which is assessed using the French modified version of Venham scale [Time Frame: at T1 (first contact)]

The level of patient stress which is assessed using the French modified version of Venham scale [Time Frame: at T8 (end of dental treatment)]

Satisfaction level of the accompanying person which is assessed using the French modified version of Venham scale [Time Frame: 48 hours after dental care (T14).]

Secondary ID(s)

CHU-0155

Source(s) of Monetary Support

Please refer to primary and secondary sponsors