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

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.

Conditions

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

Interventions

DRUG

Omega 3

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

DRUG

Vit 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.

DRUG

Zinc 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.

DRUG

Statins (Cardiovascular Agents)

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.

DRUG

Hydroxy Urea

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.

DRUG

Folic Acid Supplementation

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

DRUG

Morphine 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.

PROCEDURE

blood transfusion session

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

Sponsors & Collaborators

• Benisuef university hospital

  collaborator UNKNOWN

• University of Arizona

  collaborator OTHER

• Maternity and Children Hospital, Makkah

  collaborator OTHER

• Beni-Suef University

  lead OTHER

Principal Investigators

• John E. Murphy [Professor of Pharmacy Practice and Science], PharmD · University of Arizona, College of Pharmacy

• Mohamed H Meabad [Prof of Pediatrics], M.D · Beni-Suef University, Faculty of medicine

• AHMED A ALBERRY [Assistant prof of clinical pharmacology], M.D · Beni-Suef University, Faculty of medicine

• RAGHDA R SAYED [Lecturer of Clinical Pharmacy, Ph.D. · Beni-Suef University, Faculty of Pharmacy

• Shaimaa M Nashat Sayed Abdelhalim, Ph.D Student · Beni-Suef University, Faculty of Pharmacy

• Ahmed F Mahmoud Hussein, MS.c · Beni-Suef Health insurance hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

5 Years

Max Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-11-01

Primary Completion

2020-11-01

Completion

2020-12-10

Countries

• Egypt
• Saudi Arabia

Study Locations