Study: NCT04301336

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Hydroxy Urea
Description: 50 patients from each participating hospital that will receive the ordinary treatment of Hydroxyurea (20 mg/kg/day) with monitoring blood count every 2 weeks maximum daily dose: (40 mg/kg/day) for 8 consecutive months up to 10 months.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Folic Acid Supplementation
Description: Folic Acid dose of 0.5 to 1 mg daily for 3 to 4 weeks until definite hematologic response

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Folic Acid Supplementation
Description: Folic Acid dose of 0.5 to 1 mg daily for 3 to 4 weeks until definite hematologic response

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Folic Acid Supplementation
Description: Folic Acid dose of 0.5 to 1 mg daily for 3 to 4 weeks until definite hematologic response

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Folic Acid Supplementation
Description: Folic Acid dose of 0.5 to 1 mg daily for 3 to 4 weeks until definite hematologic response

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Folic Acid Supplementation
Description: Folic Acid dose of 0.5 to 1 mg daily for 3 to 4 weeks until definite hematologic response

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Morphine Sulfate
Description: Morphine medication as a pain killer is administered, if Patient weight \<50 kg: Opioid naïve: Initial: 0.05 mg/kg/dose; usual maximum initial dose: 1 to 2 mg/dose.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Morphine Sulfate
Description: Morphine medication as a pain killer is administered, if Patient weight \<50 kg: Opioid naïve: Initial: 0.05 mg/kg/dose; usual maximum initial dose: 1 to 2 mg/dose.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Morphine Sulfate
Description: Morphine medication as a pain killer is administered, if Patient weight \<50 kg: Opioid naïve: Initial: 0.05 mg/kg/dose; usual maximum initial dose: 1 to 2 mg/dose.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Morphine Sulfate
Description: Morphine medication as a pain killer is administered, if Patient weight \<50 kg: Opioid naïve: Initial: 0.05 mg/kg/dose; usual maximum initial dose: 1 to 2 mg/dose.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Morphine Sulfate
Description: Morphine medication as a pain killer is administered, if Patient weight \<50 kg: Opioid naïve: Initial: 0.05 mg/kg/dose; usual maximum initial dose: 1 to 2 mg/dose.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: blood transfusion session
Description: Regular blood transfusion session based on patient hematological profile starts from one session every 2 weeks.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: blood transfusion session
Description: Regular blood transfusion session based on patient hematological profile starts from one session every 2 weeks.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: blood transfusion session
Description: Regular blood transfusion session based on patient hematological profile starts from one session every 2 weeks.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: blood transfusion session
Description: Regular blood transfusion session based on patient hematological profile starts from one session every 2 weeks.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: blood transfusion session
Description: Regular blood transfusion session based on patient hematological profile starts from one session every 2 weeks.