Sickle cell pain
Conditions
Interventions
N-acetylcystein 600mg twice a day or placebo twice a day
Sponsors
Academisch Medisch Centrum
Eligibility
Age
12 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age 12 years or older - Either HbSS, HbSC, HbS*0- or HbS*+-thalassemia genotype - History of at least 1.0 painful crisis per year in the past 3 years (hospital admission is not obligatory here). - Written informed consent from patient/parent/guardian
Exclusion criteria
Exclusion criteria: - Chronic blood transfusion or transfusion in the preceding 3 months - Painful crisis in the last 4 weeks (hospital admission is not obligatory here) - Pregnancy, breastfeeding or the desire to get pregnant in the following 9 months - Known active gastric/duodenal ulcers - Hydroxycarbamide (HC) treatment with unstable dose in the last 3 months or started on HC shorter then 6 months prior to study. - Known poor compliance in earlier trials regarding the completion of pain diaries. - Insufficient compliance in run-in period. - - Known of hypersensitivity to acetylcysteine or one of the other components of the study medication -Use of pain medication for sickle-cell related pains on more than 15 days per month in the past 6 months (*chronic pain*).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The frequency sickle cell-related pain in daily life | — |
Secondary
| Measure | Time frame |
|---|---|
| - The severity of sickle cell related pain in daily life. - The frequency and severity of painful crises in daily life. - The frequency and severity of hospital admission for painful crises - The health related quality of life, - Societal costs of SCD related care - Hematological markers of oxidative stress, hemolysis, hypercoagulability, inflammation and endothelial dysfunction. - The tolerability of NAC - The frequency of use of pain medication at home - The frequency of SCD complications (e.g. stroke) - Time in days to first painful crisis and first hospital admission | — |
Countries
Netherlands
Outcome results
None listed