Midazolam Sedation in Dentally Anxious Patients

NCT01874717 | Completed Phase 3

• 1 other identifier: CHU-0155
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dental Anxiety

Keywords

Conscious sedation; Dental anxiety; Oral midazolam; Intravenous midazolam; Behaviour

Outcome Measures

Primary Outcomes (4)

• 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)

Secondary Outcomes (5)

• 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).

Study Arms (2)

oral midazolam

EXPERIMENTAL

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

Other: Conscious sedation for dental care; Drug: midazolam

intravenous midazolam

OTHER

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

Other: Conscious sedation for dental care; Drug: midazolam

Interventions

Conscious sedation for dental care OTHER

intravenous midazolam; oral midazolam

midazolam DRUG

intravenous midazolam; oral midazolam

Eligibility Criteria

• Age: 8 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

• 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.

  PMID: 23940729 DERIVED

MeSH Terms

Conditions

Behavior

Interventions

Conscious Sedation; Dental Care; Midazolam

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Dentistry; Dental Health Services; Health Services; Health Care Facilities Workforce and Services; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Valérie COLLADO

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2013
• First Posted: June 11, 2013
• Study Start: June 1, 2005
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: June 11, 2013

Record last verified: 2013-06

Locations

FR (1)