This study is designed to compare the antipyretic effect of intravenous ibuprofen with oral ibuprofen or diclofenac suppositoriy in children. Through this randomized controlled trial, 90 children admitted in Shahid Beheshti Hospital of Kashan will be studied. Inclusion criteria included: Children aged 1 to 6 years with axillary temperature over 38 degrees. Exclusion criteria included: The use of anti pyretic drug before admission; diarrhea; drug intolerance; using techniques such as sponge. The patients will be randomly assigned to three groups. First group (N= 30 cases) will receive 5 mg/kg intravenous ibuprofen and the second group (N= 30 cases) will receive 5 mg/kg oral ibuprofen and the third group (N= 30 cases) will receive 1 mg/kg diclofenac rectally. Then, the body temperature will be assessed at the end of the first hour and will be compared between three groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014052711145N10
Registration date:2014-08-12, 1393/05/21
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-08-12, 1393/05/21
Registrant information
Name
Mohammad Reza Sharif
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0026
Email address
sharif_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2015-05-22, 1394/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Antipyretic effect of intravenous ibuprofen compared to oral ibuprofen and rectal diclofenac in children
Public title
Antipyretic effect of intravenous ibuprofen compared to oral ibuprofen or rectal diclofenac in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Children admitted in Shahid Beheshti Hospital; axillary temperature over 38 degrees; aged 1 to 6 years. Exclusion criteria: The use of anti pyretic drug before admission; diarrhea; drug intolerance; using techniques such as sponge.
Age
From 1 year old to 6 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd, Kashan, Iran
City
Kashan
Postal code
Approval date
2014-08-06, 1393/05/15
Ethics committee reference number
29.5.1.2150
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
Axillary temperature
Timepoint
One hour after drug perception
Method of measurement
Mercury thermometer
Secondary outcomes
empty
Intervention groups
1
Description
Ibuprofen, 5 mg/kg , intravenous, single dose at the initiation of fever control
Category
Treatment - Drugs
2
Description
Ibuprofen, 5 mg/kg , oral, single dose at the initiation of fever control
Category
Treatment - Drugs
3
Description
Diclofenac, 1 mg/kg , rectal, single dose at the initiation of fever control