Optimization of Procedural Sedation Protocol Used for Dental Care Delivery in People With Mental Disability
Overview
- Phase
- Phase 4
- Intervention
- Midazolam Mylan
- Conditions
- Dental Care for Disabled
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Level of cooperation of patient when receiving regular dental care
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
Brief Summary
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
Investigators
Eligibility Criteria
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
Arms & Interventions
Midazolam
Midazolam Mylan 5 mg/ml solution for injection 15mg Oral use Single dose 45 minutes before dental treatment
Intervention: Midazolam Mylan
Lorazepam / Valium+Akineton+Dehydrobenzperidol+Atropine sulfat
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
Intervention: Lorazepam Mylan
Lorazepam / Valium+Akineton+Dehydrobenzperidol+Atropine sulfat
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
Intervention: Valium + Akineton + Dehydrobenzperidol + Atropine sulfate
Outcomes
Primary Outcomes
Level of cooperation of patient when receiving regular dental care
Time Frame: Participants will be followed for the duration of the dental treatment, an expected average of 30 minutes.
Secondary Outcomes
- Recording of vital parameters during regular dental care delivery(24 hrs)
- Level of patient comfort and possible side-effects after dental treatment session(24 hrs)