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Quality of life of adult patients with sickle cell disease is deeply impaired by severe adverse medical events that inadvertently occur throughout their time life. Indeed, patients not presenting a life threatening condition often present to the emergency department with sickle cell disease crisis related pain. Currently, the effectiveness of specific analgesic strategies for treating sickle cell disease crisis related pain are mostly based on acetaminophen and opioid derivates combination along with oxygen delivery. Those strategies are effective but may last up to half an hour to obtain pain relief. This delay mostly depends on the availability of venous access and on individual patient response to treatment. Nitrous oxide is a volatile efficient analgesic therapy that has been repeatedly shown to allow rapid analgesia in the emergency department setting.
The investigators hypothesise that a new analgesic strategy (rapid optimized analgesic strategy) including nitrous oxide and nefopam would be as safe and more rapidly effective than current analgesic strategy.
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Purpose of the study:
The main objective is to evaluate the effectiveness of an optimized combination of analgesic therapies for treating uncomplicated sickle cell disease crisis at initial visit to the emergency room of the Henri Mondor hospital.
Secondary objectives:
Total amount of morphine required during the first 4 hours in the hospital emergency.
Overall amount of morphine administered on the duration of patient stay in hospital Henri Mondor.
Side effects of analgesic strategies
Adverse medical events
Length of hospital stay.
7-day and 1-month follow-up and collection of following data:
Contraindications to nefopam administration: hypersensitivity to nefopam, benign prostatic hypertrophy and glaucoma, or history of seizures.
Main criterion:
Proportion of patients relieved (pain intensity by simple numerical scale <4) to 30 minutes of their arrival in the emergency department.
Secondary criteria:
amount of morphine administrated within the first 4 hours of presentation to the emergency department
overall amount of morphine administrated during hospital stay
adverse event related with study treatment
adverse medical events during hospitalization
length of stay.
7-day and 1-month follow-up to collect the following data:
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176 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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