About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- oral administration of midazolam or placebo
Treatment groups
Locations
1Sponsors and collaborators
University Hospital, Grenoble
Lead sponsor