Sickle Cell Anemia Clinical Trial
Official title:
New Analgesic Strategy Combining Nitrous Oxide, Nefopam, Acetaminophen and Morphine Compared to the Usal Antalgic Strategy (Acetaminophen and Morphine) for the Treatment of Acute Sickle Cell Disease Pain in the Emergency Room
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.
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:
1. Total number of sickle cell disease crises
2. Number of subsequent readmission and/or visit to an ED
3. Quality of life (EuroQol EQ-5D, and SF-36)
4. Patient satisfaction: pain treatment satisfaction scale. Study design: prospective
monocentric open-label randomized controlled trial Number of patients: 200 Follow
up per patient: 1 month, Study enrolment period: 25 months.
Contraindications to nefopam administration: hypersensitivity to nefopam, benign prostatic
hypertrophy and glaucoma, or history of seizures.
- contraindication to morphine administration hypersensitivity to morphine, decompensate
respiratory failure, acute head trauma, uncontrolled epilepsy, severe hepatocellular
failure, intracranial hypertension, use of buprenorphine or nalbuphine
Contraindications to MEOPA administration, intra-cranial hypertension, non cooperative
patient (sleepiness; encephalopathy, refusal to participate), pneumothorax, emphysema,
pneumoperitoneum, digestive occlusion, pneumomediastinum, air embolism, diving accident
, facial trauma, patients who recent administration of an ophthalmic gas (SF6, C3F8,
C2F6) < 3 months).
- contraindication to the use of oxygen: no-absolute contraindication no health
insurance, adults under tutelage
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:
1. Total number of sickle cell disease crises
2. Number of subsequent readmission and/or visit to an ED
3. Quality of life (EuroQol EQ-5D, and SF-36)
4. Patient satisfaction: pain treatment satisfaction scale.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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