Optimization of Procedural Sedation Protocol Used for Dental Care Delivery in People With Mental Disability (OptiSeDent)

Universitaire Ziekenhuizen KU Leuven

Status and phase: Active, not recruiting; Phase 4

Conditions: Dental Care for Disabled

Treatments: Drug: Lorazepam Mylan; Drug: Valium + Akineton + Dehydrobenzperidol + Atropine sulfate; Drug: Midazolam Mylan

Study type: Interventional

Funder types: Other

Identifiers

NCT02078336

2013-003991-11 (EudraCT Number)

S55859

Details and patient eligibility

About

The study aims to compare procedural sedation protocols, specifically applied for the delivery of regular dental care in persons with a mental disability.

The primary objectives are:

• To assess the level of cooperation during regular dental care using different procedural sedation protocols
• To assess patient safety during regular dental care using different sedation protocols
• To assess patient comfort and possible side-effects after regular dental care using different sedation protocols

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Minimum age 18yrs
• Patient resides at least 6 months in nursing home "het Gielsbos".
• Patient always gets a sedative protocol to make dental care delivery possible.
• Informed consent was obtained from parent/guardian
• No medical contra-indication for any of tested sedative protocols

Exclusion criteria

• Age under 18yrs
• The patient is no resident of the nursing home "het Gielsbos" or lives there for less than 6 months.
• No need for medicinal support during dental treatment
• No informed consent was obtained by parents or the guardian of the patient.
• Medical contra-indication for 1 of the sedative protocols

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Midazolam

Experimental group

Description:

Midazolam Mylan 5 mg/ml solution for injection 15mg Oral use Single dose 45 minutes before dental treatment

Treatment:

Drug: Midazolam Mylan

Lorazepam / Valium+Akineton+Dehydrobenzperidol+Atropine sulfat

Active Comparator group

Description:

Lorazepam Mylan 2,5 mg tabletten 2.5mg Oral use Single dose 45 minutes before dental treatment OR Valium 10 mg/2 ml solution for injection 10mg Intramuscular use Single dose 45 minutes before dental treatment + Akineton 5 mg/ml solution for injection 5mg Intramuscular use Single dose 45 minutes before dental treatment + Dehydrobenzperidol 5 mg/2 ml solution for injection 0,000125 ml/cm2 Intramuscular use Single dose 45 minutes before dental treatment + Atropine sulfate Sterop 0,25mg/1ml solution for injection 0,25mg Intramuscular use Single dose 45 minutes before dental treatment

Treatment:

Drug: Valium + Akineton + Dehydrobenzperidol + Atropine sulfate

Drug: Lorazepam Mylan