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Different Treatment Modalities in the Management of the Painful Crisis in Pediatric Sickle- Cell Anemia

Comparative Effectiveness of the Different Treatment Modalities for Management of Vaso-occlusive Painful Crisis in Pediatric Sickle Cell Disease

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04301336
Enrollment
350
Registered
2020-03-10
Start date
2019-11-01
Completion date
2020-12-10
Last updated
2021-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaso-occlusive Crisis, Sickle Cell Disease, Sickle Cell Anemia in Children

Keywords

omega3, Vaso-occlusive painful crisis, Pediatric sickle cell anemia, comparative effective analysis in VOC, Anti-inflammatory effect of Vit-D, Anti-hemolytic effect of Vit-D, Anti-hyperlipidemia of Vit-D, effect of omega-3 on blood rheology, effect of omega-3 on blood viscosity, Antiaggregation effect of omega-3, Anti-inflammatory effect of statins, Anti-inflammatory effect of zinc supplements, effect of zinc supplements on blood viscosity, effect of zinc supplements on blood rheology, Antiaggregation effect of zinc supplements, pediatric sickle cell disease

Brief summary

The aim of the present study is comparing the effectiveness of different treatment regimens for investigating the therapeutic potential for each one in management of Vaso-occlusive pain in pediatric sickle cell disease. In addition, investigators apply the Cost-effectiveness analysis (CEA) as a form of economic analysis that compares the relative costs and outcomes (effects) for different treatment regimens on vaso-occlusive painful crisis.

Detailed description

Sickle cell disease is an inherited blood disorder characterized by defective hemoglobin (a protein in red blood cells that carries oxygen to the tissues of the body). Sickle cell disease involves the red blood cells, or hemoglobin, and their ability to carry oxygen. Normal hemoglobin cells are smooth, round, and flexible, like the letter O, so they can move through the vessels in our bodies easily. Sickle cell hemoglobin cells are stiff and sticky and form into the shape of a sickle, or the letter C, when they lose their oxygen. These sickle cells tend to cluster together and cannot easily move through the blood vessels. The cluster causes a blockage in small arteries or capillaries and stops the movement of healthy, normal oxygen-carrying blood. This blockage is what causes the painful and damaging complications of sickle cell disease. Acute vaso-occlusive crisis (VOC) is a hallmark of sickle cell disease (SCD). Multiple complex pathophysiological processes can result in pain during a VOC. Despite significant improvements in the understanding and management of SCD, little progress has been made in the management of pain in SCD, although new treatments are being explored. The Painful Episodes: The day-to-day management of sickle cell disease often equates with the management of acute and chronic pain. Patients manage many painful events at home so that hospital visits underestimate the frequency of pain Acute painful episodes are the most commonly encountered vaso-occlusive events in patients of all ages. Presumed to be caused by sickle vaso-occlusion, pain often starts in young children as the hand-foot syndrome or dactylitis, a painful swelling of hands and feet due to inflammation of the metacarpal and metatarsal periosteum. Painful episodes, which last from hours to many days, usually occur with little warning and a clear precipitating event is not often found.

Interventions

DRUGOmega 3

Omega-3 supplementation (300-400mg EPA & 200-300mg DHA) per day for 8 consecutive months up to 10 months

DRUGVit D

50 patients from each participating hospital that will receive Vit-D medication (1500 IU to 3500 IU ) per day for 8 consecutive months up to 10 months. in addition to the experimental treatment, this group will receive the traditional treatment of hydroxyurea, Folic acid, pain killer plus regular blood transfusion with a dose de-escalation methods till efficacy of experimental treatment proved.

DRUGZinc sulfate

50 patients from each participating hospital that will receive Zinc supplements (15 mg to 50 mg ) per day for 8 consecutive months up to 10 months. in addition to the experimental treatment, this group will receive the traditional treatment of hydroxyurea, Folic acid, pain killer plus regular blood transfusion with a dose de-escalation methods till efficacy of experimental treatment proved.

50 patients from each participating hospital that will receive Simvastatin orally (20 mg to 40 mg ) per day for 8 consecutive months up to 10 months. in addition to the experimental treatment, this group will receive the traditional treatment of hydroxyurea, Folic acid, pain killer plus regular blood transfusion with a dose de-escalation methods till efficacy of experimental treatment proved.

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.

Folic Acid dose of 0.5 to 1 mg daily for 3 to 4 weeks until definite hematologic response

DRUGMorphine Sulfate

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.

Regular blood transfusion session based on patient hematological profile starts from one session every 2 weeks.

Sponsors

Benisuef university hospital
CollaboratorUNKNOWN
University of Arizona
CollaboratorOTHER
Maternity and Children Hospital, Makkah
CollaboratorOTHER
Beni-Suef University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Intervention model description

Four experimental groups, one control group

Eligibility

Sex/Gender
ALL
Age
5 Years to 15 Years
Healthy volunteers
No

Inclusion criteria

Any case with the full manifestation of sickle cell disease accompanied by acute painful crisis aged from 5-15 years old.

Exclusion criteria

1. The presence of any other chronic illness. 2. Patient age\>18 years old or \< 3 years old. 3. Patients with hepatic diseases including cholestasis hepatic encephalopathy and jaundice. 4. Patients with renal impairment 5. Diabetic patients

Design outcomes

Primary

MeasureTime frameDescription
C-reactive protein mg/L10 monthsC-reactive protein milligrams per deciliter
Hematocrit %10 monthsHematocrit level in percentage value
Fibrinogen mg/dl10 monthsFibrinogen concentration in milligrams per deciliter
Total cholesterol Mg/dl10 monthsTotal cholesterol milligrams per deciliter
HDL cholesterol Mg/dl10 monthsHDL cholesterol milligrams per deciliter
LDL cholesterol Mg/dl10 monthsLDL cholesterol milligrams per deciliter
Triglycerides Mg/dl10 monthsTriglycerides milligrams per deciliter
leukocytes count μl10 monthsleukocytes in microliter
hemoglobin (Hbg) g/dL10 monthshemoglobin (Hbg) gram/deciliter
White blood cells count10 monthsWhite blood cells count in a cubic milliliter of blood
Lactic acid dehydrogenase U/L10 monthsLactic acid dehydrogenase unit per litter
Reticulocyte count %10 monthsReticulocyte count percentage
Red blood cell (erythrocyte ) sedimentation rate mm/hr10 monthserythrocyte sedimentation rate in millimeters (mm) per one hour(hr)
lymphocyte count µL10 monthslymphocyte count in 1 microliter (µL) of blood
Granulocyte absolute count cells/microliter10 monthsGranulocyte cells numbers in microliter
Granulocytes,percentage (GR, pct)10 monthspercentage of white blood cells with granules in percentage

Countries

Egypt, Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026