This study is designed to compare the antipyretic effectiveness of Indomethacin with Diclofenac and Acetaminophen suppositories in children. Through this randomized controlled trial, 150 patients aged between 1 and 6 years with rectal fever more than 38˚ Celsius refer to Beheshti Hospital of Kashan, Iran will be studied. Inclusion criteria included: Children aged 1 to 6 years admitted in Beheshti Hospital with rectal 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 into one of three groups. First group (N= 50 cases) will receive 1 mg/kg Indomethacin rectally and the second group (N= 50 cases) will receive 1 mg/kg Diclofenac rectally and the third group (N= 50 cases) will receive 10 mg/kg Acetaminophen 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:IRCT2013021711145N4
Registration date:2013-03-10, 1391/12/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-03-10, 1391/12/20
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
2013-02-19, 1391/12/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing effect of Indomethacin with Diclofenac and Acetaminophen suppositories in reducing the fever in children
Public title
Comparing effect of Indomethacin with Diclofenac and Acetaminophen suppositories in reducing the fever in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Children admitted in Beheshti Hospital; rectal temperature over 38 degrees; children 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
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
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
5th Kilometer, Ghotbe Ravandi Bulv, Kashan
City
Kashan
Postal code
Approval date
2013-02-17, 1391/11/29
Ethics committee reference number
4246/1/5/29/پ
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
Rectal Temperature
Timepoint
One hour after Indomethacin, Acetaminophen and Diclofenac perception
Method of measurement
Rectal digital thermometer- Microlife
Secondary outcomes
empty
Intervention groups
1
Description
Indomethacin, 1mg/kg , suppository, single dose at the initiation of fever
Category
Treatment - Drugs
2
Description
Diclofenac, 1mg/kg , suppository, single dose at the initiation of fever
Category
Treatment - Drugs
3
Description
Acetaminophen, 10mg/kg , suppository , single dose at the initiation of fever