Objectives: Hypertension in children is a rare but important complication. The purpose of study is assessing the effect of antihistamines (diphenhydramine) on blood pressure in children with common cold.
Design: This study is a clinical trial conducted on children at the age of 2-18 years, suffering from common cold, refered to Amir Kabir Hospital.
Setting and conduct: In this study after obtaining informed consent from the children blood pressure will be recorded and then 2-3 days after receiving diphenhydramine syrup, blood pressure will be recorded. If there is hypertension parents must be notified to apply for diagnosis and treatment. This is a one-group before after study. After drug consumption by all patients, blood pressure will be measured for the second time and will be compared with the initial blood pressure.
Major eligibility criteria: 110 children with common cold without any underlying problem and any chronic illness are included in the study, and patients who do not agree to participate in the study are excluded from the study There is no control group in this study. Intervention: administration of Diphenhydramine at a dose of 1-5 mg / kg / day. Control group: There is no control group.
The main outcome measure variable: blood pressure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017060413366N8
Registration date:2017-07-02, 1396/04/11
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-07-02, 1396/04/11
Registrant information
Name
Parsa Yousefi Chaijan
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1312 1964
Email address
dr.yousefi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Arak University of Medical Sciences
Expected recruitment start date
2017-07-06, 1396/04/15
Expected recruitment end date
2018-07-06, 1397/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Antihistamines (Diphenhydramine) on Blood Pressure in Children with Common Colds.
Public title
Diphenhydramine Effect on Blood Pressure in Children with Common Colds
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with common colds; 2 to 18 years of age.
Exclusion criteria: age lower than 2 years of age؛ age over 18 years of age؛ people with underlying chronic disease؛ those taking medications affecting blood pressure؛ people who don't have not consent to the study.
Age
From 2 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Arak University of Medical Sciences
Street address
3848176941,Arak University of Medical Sciences, Sardasht, Arak.
City
Arak
Postal code
3848176941
Approval date
2016-07-18, 1395/04/28
Ethics committee reference number
IR.ARAKMU.REC.1395.140
Health conditions studied
1
Description of health condition studied
Hypertension
ICD-10 code
I10
ICD-10 code description
High blood pressure
2
Description of health condition studied
common cold
ICD-10 code
J00
ICD-10 code description
Nasal catarrh and acute Nasopharyngitis
Primary outcomes
1
Description
blood pressure
Timepoint
Beginning and end of medical intervention within 72 hours
Method of measurement
Blood pressure measurement by researcher
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Diphenhydramine at a dose of 1-5 mg / kg / day for 2-3 days..
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Pediatrics, Amir Kabir Hospital
Full name of responsible person
Dr. Parsa Yousefichaijan
Street address
3819693345, Amir Kabir Hospital, Basij Square, Arak.
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences
Full name of responsible person
Ali Arash Anoushirvani
Street address
3819693345, Vice Chancellor for Research, Arak University of Medical Sciences, Sardasht, Arak.
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Arak University of Medical Sciences