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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: August 2014

Interventions

  • Drug: Midazolam Mylan
  • Drug: Lorazepam Mylan
  • Drug: Valium + Akineton + Dehydrobenzperidol + Atropine sulfate

Arms, Groups and Cohorts

  • Experimental: Midazolam
    • Midazolam Mylan 5 mg/ml solution for injection 15mg Oral use Single dose 45 minutes before dental treatment
  • Active Comparator: 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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Recording of vital parameters during regular dental care delivery
    • Time Frame: 24 hrs
    • The measure is a composite of recording of blood pressure recording of pulse recording of oxygen saturation
  • Level of patient comfort and possible side-effects after dental treatment session
    • Time Frame: 24 hrs
    • The measure of patient comfort and possible side-effects after dental treatment session is a composite of changes in appetite changes in toilet behavior changes in level of consciousness changes in level of concentration changes in pattern of epileptic insults changes in mood changes in sleeping pattern changes in level of motor skills

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universitaire Ziekenhuizen Leuven
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dominique Declerck, Principal Investigator, KU Leuven
  • Overall Contact(s)
    • Dominique Declerck, dominique.declerck@med.kuleuven.be

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