Comparison of the effect of acetaminophen syrup with oral ibuprofen in reducing pain caused by peripheral vascularization in children with acute lymphoblastic leukemia.
Comparison of the effect of acetaminophen syrup with oral ibuprofen in reducing pain caused by peripheral vascularization in children with acute lymphoblastic leukemia.
Design
A clinical trial with a control group with parallel and double-blind randomized phase 2 of 90 patients with a randomization method using the rand function of Excel software.
Settings and conduct
This Double Blind (in Patient and Caretaker) study will be done in Hematology & Oncology ward in Bu-Ali-Sina Hospital in Sari, Mazandaran So that the drugs with the same volume and appearance reach the respected nurse without prior notice, and one hour after prescribing the drug, vein sampling is done by the same nurse and the results are recorded by her.
Participants/Inclusion and exclusion criteria
All children Diagnosed with ALL and Age between 3-12 years old are included
patients with Allergic histoty of Acetaminophen or Ibuprofen
patients with consumption of drugs which may have cross reactions with the given drugs
patients with plt<50,000
patient with Neutrophil count < 1500
patient with Fever or Nausea/ Vomiting
Intervention groups
First group with Acetaminophen Syrup , 15mg/kg
Second group with Ibuprofen syrup , 10mg/kg
Third group no interference and be giving Placebo with same Volume and Color
Main outcome variables
Pain reduction in patients and their families & progress in cure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190202042583N5
Registration date:2023-11-11, 1402/08/20
Registration timing:prospective
Last update:2023-11-11, 1402/08/20
Update count:0
Registration date
2023-11-11, 1402/08/20
Registrant information
Name
Mohammad Naderisorki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3334 7837
Email address
dr.naderisorki@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of acetaminophen syrup with oral ibuprofen in reducing pain caused by peripheral vascularization in children with acute lymphoblastic leukemia.
Public title
Comparing the effect of acetaminophen and ibuprofen in reducing the pain of venipuncture
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All Children between 3-12 years old diagnosed with ALL came for Chemotherapy
Exclusion criteria:
People younger than 3 years old and older than 12 years old
Neutrophil < 1500
Alergic history of Acetaminophen/ Ibuprofen
Plt<50,000
Fever & Nausia/ Vomitting
Hb < 8g/litre
Hepatic disfunction
Age
From 3 years old to 12 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
We divide each client into two groups using a random table. This table is a set of numbers. Consider the numbers 1 to 19 for intervention A and the numbers 20 to 38 for control B (for both size groups larger and smaller than 4 cm). Then we touch one of the numbers and move into one of the predetermined directions and record the numbers and assign them to one of the groups. In this way, patients are divided completely randomly.
Blinding (investigator's opinion)
Double blinded
Blinding description
This Study is Double Blind and the patients and the care takers are unaware of the drugs type which have the same color, Volume and Tube.In addition, The psychiatrist observing the images is not aware of the type of medication received.
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Se-rah-Joibar, Sari
City
Sari
Province
Mazandaran
Postal code
48157-33971
Approval date
2023-08-15, 1402/05/24
Ethics committee reference number
IR.MAZUMS.REC.1402.305
Health conditions studied
1
Description of health condition studied
Acute lymphoblastic leukemia
ICD-10 code
C91.0
ICD-10 code description
Acute lymphoblastic leukemia [ALL]
Primary outcomes
1
Description
Drug effects on pain reduction during IV needle insertion
Timepoint
Pain reduction of needle insertion 60 minutes after oral taking of drugs
Method of measurement
Ouches pain scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: prescription of acetaminophen syrup with 15mg/kg dosing, once, taken orally 1hour before needle insertion
Category
Treatment - Drugs
2
Description
Intervention group: prescription of Ibuprofen syrup with 1omg/kg dosing, once, taken orally 1hour before needle insertion
Category
Treatment - Drugs
3
Description
Control group: prescription of placebo with same amount as previous drugs once, taken orally 1hour before needle insertion
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu-Ali Sina Hospital
Full name of responsible person
Mohammad NaderiSorki
Street address
Bu Ali Sina Hospital, Pasdaran Blvd, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3011
Email
Dr.naderisorki@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Pedram Ebrahim Nejad
Street address
Moalem Square, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3325 7230
Email
pebrahimnejad@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Naderisorki
Position
Assistant Professor professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Bu Ali Sina Hospital, Pasdaran Bulv
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3011
Email
Dr.naderisorki@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Naderisorki
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Bu Ali Sina Hospital, Pasdaran Bulv.
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۸۳۸۴۷۷
Phone
+98 11 3334 3011
Email
Dr.naderisorki@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Naderisorki
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Bu Ali Sina Hospital, Pasdaran Bulv
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3011
Email
Dr.naderisorki@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available