Sickle Cell Anemia Clinical Trial
— DREPANOXOfficial 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
Verified date | November 2012 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 176 |
Est. completion date | November 2012 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - male adult patient with sickle cell anemia, - age = 18 years, - main complaint : sickle cell crisis pain, - initial numeric pain intensity scale at presentation > 4, - admission to the ED during working hours (amendment n°2-15/02/2010:from 8h to 20h), from Monday to Friday Exclusion Criteria: - female adult patient - complicated sickle cell crisis or admission requirement to an ICU - recent hospitalisation (< 10 days) for the same complaint - previous inclusion in the study - contraindication to anyone of the study drugs - no medical insurance - incompetent adult |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Henri Mondor Hospital, Emergency Department | Créteil |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of pain relief (Numeric Pain Intensity Scale < 4) | at 30 min after admission to the ED | No | |
Secondary | Overall amount of morphine delivered | during the first 4 hours of ED presentation | No | |
Secondary | Overall amount of morphine delivered | during the hospital stay following ED presentation and enrolment in the study | No | |
Secondary | Analgesic drugs related adverse events | during the hospital stay following ED presentation and enrolment in the study | Yes | |
Secondary | Length of hospital stay | during the hospital stay | No | |
Secondary | Overall number of sickle cell crisis and patients'quality of life (EuroQol-EQ 5D, SF-36) and patients' satisfaction regarding pain management (pain management satisfaction questionnaire) | at 7 days and 30 days of follow-up. | No | |
Secondary | measurement of oxygen saturation in tissue (amendment n°1 - 14/09/2009) | measurement of oxygen saturation in tissue | in 4hours after admission to the emergency | No |
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