Investigating the effectiveness of L-arginine in reducing duration of hospitalization and pain intensity of children with sickle cell disease compared to placebo.
Investigating the effectiveness of L-arginine in reducing duration of hospitalization and pain intensity of children with sickle cell disease compared to placebo.
Design
Pragmatic, community based, parallel group, double blind, randomised controlled trial
Settings and conduct
This study will be done in the hematology ward Shafa Hospital of Ahvaz.This study will be a double blind trial that patients and nurses will be blinded to the type of interventions. Blinding technique will be samed in shape, color, size and taste in the study group.
Participants/Inclusion and exclusion criteria
Inclusion:Patients affected by Sicklecel between the ages of 3 to 20 years old.
Exclusion: liver failure; renal failure under 5 grams of hemoglobin per deciliter; patients in need of immediate infusion of blood; pregnancy; history of hospitalization more than 10 times in the hospital; a history of opiate dependence; sensitivity to arginine
Intervention groups
L-arginine group: 100 mg/kg IV or oral, 3 times per day.
Placebo group:100 mg/kg IV or oral 3 times per day.
Main outcome variables
Reduced hospitalization time; Reduced pain intensity in sickle cell patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170112031891N2
Registration date:2018-04-09, 1397/01/20
Registration timing:retrospective
Last update:2018-04-09, 1397/01/20
Update count:0
Registration date
2018-04-09, 1397/01/20
Registrant information
Name
Nima Mahmoudzadeh
Name of organization / entity
Jundishapoor University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
-
Email address
mahmoudzadeh.n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Jundishapoor University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of L-arginine in reducing duration of hospitalization and pain intensity of children with sickle cell disease compared to placebo.
Public title
Investigating the effectiveness of L-arginine in reducing duration of hospitalization and pain intensity of children with sickle cell disease compared to placebo.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients affected by sickle cell disease
Age 3 to 20 years
Exclusion criteria:
liver failure
Renal failure
Under 5 grams of hemoglobin per deciliter
Patients in need of immediate infusion of blood
Pregnancy
History of hospitalization more than 10 times in the hospital
A history of opiate dependence
Sensitivity to arginine
Age
From 3 years old to 20 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the 6-block method, individuals will be divided randomly into two equal groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients and nurses who prescribed medications to patients are blinded to the type of drugs. The main drug and placebo are the same in terms of shape, size, taste and packaging.The physician that collect treatment outcomes will not be blinded about allocation of interventions.
Placebo
Used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan street, Shahr Daneshgahi, Deputy of Research and Technology Development of Ahvaz Jondishapur University of Medical Sciences, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2017-05-27, 1396/03/06
Ethics committee reference number
ir.ajums.rec.1396.190
Health conditions studied
1
Description of health condition studied
Sickle cell disease
ICD-10 code
D57.81
ICD-10 code description
Other sickle-cell disorders with crisis
Primary outcomes
1
Description
Pain
Timepoint
A week
Method of measurement
Based on Visual Analogue Scale and Faces Pain
2
Description
Time of Hospitalization
Timepoint
The duration of treatment
Method of measurement
The duration of Hospitalization
Secondary outcomes
1
Description
Pharmaceutical allergy
Timepoint
The duration of treatment
Method of measurement
Clinical observation
Intervention groups
1
Description
L-arginine drug orally or intravenously at a dose of 100 mg / kg, three times a day until discharge from hospital
Category
Treatment - Drugs
2
Description
Placebo drug orally or intravenously at a dose of 100 mg / kg, three times a day until discharge from hospital