The purpose of this study is to assess the effectiveness of oral midazolam on the delivery of care in elderly patients with moderat to severe neurocognitive disorders and opposing care.
Patient hospitalized (for a minimum estimated duration of 21 days) in a geriatric department in Medical Care and Rehabilitation, Cognitive-Behavioral Unit, or housed in a Reinforced Housing Unit, in a Long-Term Care Unit, or in a Psycho-Geriatric Unit.
Moderate to severe cognitive impairment, defined by a MMSE (Mini Mental State Examination) score <15. If not feasible at inclusion, MMSE score <15 less than 1 year old.
Patient opposed to care, presenting at least two episodes of opposition to care (meals excluded) for which other non-medication alternatives have failed. These refusals of care are defined by a "resistance to care" score ≥3 on the Pittsburgh scale, over the last week. In practice, the resistance to care of patients is noted in the medical record following a weekly multidisciplinary decision.
Person affiliated with social security or beneficiary of such a scheme
Patient who has received midazolam treatment in the week before inclusion
Known hypersensitivity to the active substance, benzodiazepines, or any of the excipients
Weight <50 kg and >100 kg
Gastrointestinal pathology that may limit or prevent the absorption of midazolam
Crossover
oral administration of midazolam or placebo
DrugIf the patient is opposed to a treatment (resistance to care ≥3 on the Pittsburgh scale), the nurse administers an oral dose of midazolam or placebo to the patient according to the random allocation.
Evolution of resistance to care following oral administration of midazolam
The efficacy will be evaluated by a decrease of at least two points in the resistance to care dimension of the Pittsburgh scale. the care dimension scale has 4 points, 4 is the worst score, 0 is the better.
effectiveness of oral midazolam in terms of acceptance of care
The acceptance of care is evaluated using the care acceptance scale by Rignell et al. (2007). This scale rangin from 1 to 4. the wrongest score is.
Evolution of agitation and refusal to care following oral administration of midazolam
Agitation and refusal of care will be evaluated using the global score of the Pittsburgh Agitation Scale. The scale ranging from 0 to 16. the wrongest score is 16
Number and description of Treatment-Related Adverse Events.
Measurement of saturation, respiratory rate, and heart rate, and collection of serious and non-serious adverse events occurring after the administration of midazolam gel.
Satisfaction of the caregiving staff.
Satisfaction questionnaire on the caregivers; sense of well-being towards patients.
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