NCT01874717|CompletedPhase 3
Midazolam Sedation in Dentally Anxious Patients
Conscious Sedation With Midazolam in Dentally Anxious Patients: Effect of the Administration Route (Oral Versus Intravenous Administration)
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Conscious Sedation With Midazolam in Dentally Anxious Patients: Effect of the Administration Route (Oral Versus Intravenous Administration)
Sponsor study identifier
interventional
131
1 country
1
Study Start
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2007
Actual (reported)Study Completion
August 2007
Actual (reported)Use lay language. To compare patient level of cooperation during dental care under conscious sedation with midazolam according to the administration route
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2007
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
August 2007
Actual (reported)August 2007
Actual (reported)May 28, 2013
Actual (reported)June 11, 2013
Actual (reported)Patient level of cooperation which is assessed using the French modified version of Venham scale
This scale offers a good description of behaviour and anxiety in one score (from0 to 5)
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
This scale offers a good description of behaviour and anxiety in one score (from 0 to 5)
During venous cannulation (at day 1)
Patient level of cooperation which is assessed using the French modified version of Venham scale
This scale offers a good description of behaviour and anxiety in one score (from0 to 5)
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
This scale offers a good description of behaviour and anxiety in one score (from0 to 5)
During the first dental care procedure (at day 1)
The level of patient stress which is assessed using the French modified version of Venham scale
at T1 (first contact)
The level of patient stress which is assessed using the French modified version of Venham scale
at T8 (end of dental treatment)
Satisfaction level of the patient which is assessed using the French modified version of Venham scale
48 hours after dental care (T14).
Satisfaction level of the accompanying person which is assessed using the French modified version of Venham scale
48 hours after dental care (T14).
Satisfaction level of the operator which is assessed using the French modified version of Venham scale
48 hours after dental care (T14).
oral administration of midazolam : the dose administered is twice the individual dose determined in session 1.
intravenous administration of midazolam at the individual dose determined in session 1
CHU Clermont-Ferrand
Clermont-Ferrand, 63003, France
Collado V, Faulks D, Nicolas E, Hennequin M. Conscious sedation procedures using intravenous midazolam for dental care in patients with different cognitive profiles: a prospective study of effectiveness and safety. PLoS One. 2013 Aug 5;8(8):e71240. doi: 10.1371/journal.pone.0071240. Print 2013.
Valérie COLLADO
University Hospital, Clermont-Ferrand
131 participants (actual enrollment reported by the registry).
First Submitted
May 28, 2013
First Posted
June 11, 2013
Study Start
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
August 2007
Actual (reported)Study Completion
August 2007
Actual (reported)Last Updated
June 11, 2013
Record last verified: 2013-06
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Source: ClinicalTrials.gov.
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