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Comparison antipyretic effect of Acetaminophen and Ibuprofen alone and together infant and children between 6 month and 10 years of age

Protocol summary

Summary
Background: Fever is a natural response to infection that annually hosts approximately 70 % of preschool children. Acetaminophen is widely used as an antipyretic drug with high efficiency and safety. Ibuprofen is one of the Propionic acid derivatives in which like acetaminophen. Use paracetamol plus Ibuprofen increasingly used to treat fever associated symptoms, but it is unclear whether the combination of the two is better than using each alone or not. The aim of this study is comparison of Acetaminophen and ibuprofen to control fever with the combination of both. According to a study conducted by Alastair D Hay and colleagues, 540 patients with fever higher than 38 entered to the study. The patients randomized into three groups to receive acetaminophen, ibuprofen and acetaminophen + ibuprofen. Before taking the drugs were measured fever and consequently after 2, 4 and 6 hours fever temperatures were measured. Information about each patient included age, sex , weight , temperature, duration of fever , antibiotics , acetaminophen or ibuprofen before you go to the doctor , appetite , sleep , activity of disease at diagnosis, history of asthma , a history of febrile seizures in the past, they will be excluded and patients will be enrolled who have previously received nothings . Information collected will be analyzed after entering in the SPSS program with one way Analysis of Variance and tukey test.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013120815706N1
Registration date: 2014-01-28, 1392/11/08
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-01-28, 1392/11/08
Registrant information
Name
Noor Mohammad Noori
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 1342 5611
Email address
dr_noori_cardio@yahoo.com
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2014-01-20, 1392/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison antipyretic effect of Acetaminophen and Ibuprofen alone and together infant and children between 6 month and 10 years of age
Public title
Comparison antipyretic effect of Acetaminophen and Ibuprofen alone and together
Purpose
Treatment
Inclusion/Exclusion criteria
From all feverish children between 6 months to 10 years who presented to the emergency center for children of Ali ibn Abi Talib Hospital, those considered for study with fever above 38 as inclusion criteria. Children who need hospitalization, they are clinically dehydrated; history of intolerance, allergies and contraindications or drug use have chronic lung disease except asthma , cardiac, neurologic , hepatic and renal have and their parents ability to care for children at home may not be excluded.
Age
To 10 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 540
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Zahedan University of Medical Sciences (ZaYMS)
Street address
Dr Hesabi Circle, ZaYMS Pardis
City
Zahedan
Postal code
Approval date
2012-09-27, 1391/07/06
Ethics committee reference number
91-1064

Health conditions studied

1

Description of health condition studied
Fever
ICD-10 code
R50.9
ICD-10 code description
Fever, unspecified

Primary outcomes

1

Description
Fever
Timepoint
2, 4, 6 hours after consumption
Method of measurement
Using axillary thermometer method

Secondary outcomes

empty

Intervention groups

1

Description
Temperature of fever at the start for each group is considered as a control. It should be noted that all three groups before the intervention were similar in all respects. Then the group A we took acetaminophen of 120mg/5ml with dose 15 mg per kg of body weight every six hours for 24 hours.
Category
Treatment - Drugs

2

Description
In group B, ibuprofen of 100mg/5ml with dose of 10 mg per kg every six hours for 24 hours.
Category
Treatment - Drugs

3

Description
and in Group C acetaminophen dose of 15 mg per kg of body weight and ibuprofen at a dose of 10 mg per kg of body weight the body was given every six hours for 24 hours. Therefore, control considered at the time of entrance and intervention considered after entrance.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Ali Hospital
Full name of responsible person
Dr Qasem Miri Aliabadi
Street address
Zahedan, Imam Ali Hospital
City
Zahedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of resaerch
Full name of responsible person
Vahideh Ghodrati
Street address
Zahedan, Imam Ali Hospital
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of resaerch
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Noor Mohammad Noori
Position
MD, Pediatrician
Other areas of specialty/work
Street address
Zahedan University of Medical Sciences, Imam Ali Hospital
City
Zahedan
Postal code
Phone
+98 54 1342 5611
Fax
Email
dr_noori_cardio@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Noor Mohammad Noori
Position
MD, Pediatrician
Other areas of specialty/work
Street address
Imam Ali Hospital
City
Zahedan
Postal code
Phone
+98 54 1342 5611
Fax
Email
dr_noori_cardio@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Masoomeh Ghanbari
Position
Expert for the center of Children health Center
Other areas of specialty/work
Street address
Imam Ali Haspital
City
Zahedan
Postal code
Phone
+98 54 1342 5611
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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