This study is designed to compare the antipyretic effectiveness of intravenous and rectal Acetaminophen and rectal Diclofenac in febrile children. Through this randomized controlled trial, 120 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= 40 cases) will receive 15 mg/kg Acetaminophen rectally and the second group (N= 40 cases) will receive 10 mg/kg Acetaminophen (IV) and the third group (N= 40 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:IRCT2012101711145N1
Registration date:2012-11-10, 1391/08/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-11-10, 1391/08/20
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
2012-10-22, 1391/08/01
Expected recruitment end date
2013-10-23, 1392/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intravenous Acetaminophen, Diclofenac suppository and Acetaminophen suppository in febrile hospitalized children
Public title
Comparison of intravenous Acetaminophen, Diclofenac suppository and Acetaminophen suppository in febrile hospitalized 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:
120
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 Km of Ghotbe Ravandi Bulv.
City
Kashan
Postal code
Approval date
2012-10-17, 1391/07/26
Ethics committee reference number
پ/29/5/1/2742
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 Acetaminophen and Diclofenac perception
Method of measurement
Rectal digital thermometer- Microlife
Secondary outcomes
empty
Intervention groups
1
Description
Acetaminophen, 15mg/kg , suppository, single dose at the initiation of fever
Category
Treatment - Drugs
2
Description
Acetaminophen, 10mg/kg , intravenous, single dose at the initiation of fever
Category
Treatment - Drugs
3
Description
Diclofenac, 1mg/kg , suppository, single dose at the initiation of fever
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Hospital
Full name of responsible person
Dr. Mehrdad Hossein pour
Street address
5th Km of Ghotbe Ravandi Bulv.
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholam Ali Hamidi
Street address
5th Kilometer Ghotbe Ravandi Bulv.Kashan University of Medical Sciences
City
kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr.Mohammad Reza Sharif
Position
Assistant Professor, Pediatric Infectious Diseases Subspecialist
Other areas of specialty/work
Street address
5th Kilometer Ravand Bulv. Beheshti Hospital
City
Kashan
Postal code
Phone
+98 36 1555 0026
Fax
Email
sharif_m@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr.Mohammad Reza Sharif
Position
Assistant Professor, Pediatric Infectious Diseases Subspecialist
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)