This study is designed to compare the antipyretic effectiveness of 15 and 30 mg/kg dosages of rectal Acetaminophen in febrile children. Through this randomized controlled trial, 80 patients aged between 6 months and 6 years with rectal fever more than 39˚ Celsius refers to 17 Shahrivar Hospital of Rasht, Iran will be studied. The patients will be randomly assigned into one of two groups. First group (N= 40 cases) will receive 15 mg/kg and the second group (N= 40 cases) will receive 30 mg/kg Acetaminophen rectally. Then, the body temperature will be assessed at the end of the first and third hour and will be compared between two groups.
General information
Acronym
Comparison of usual versus high-dose rectal Acetaminophen
IRCT registration information
IRCT registration number:IRCT138806182438N1
Registration date:2010-03-01, 1388/12/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-03-01, 1388/12/10
Registrant information
Name
Houman Hashemian
Name of organization / entity
Guilan University of medical sciences- Medical faculty- 17 Shahrivar hospital
Country
Iran (Islamic Republic of)
Phone
+98 13 3336 9061
Email address
hashemian@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
1998-09-23, 1377/07/01
Expected recruitment end date
2010-03-20, 1388/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of usual versus high-dose rectal Acetaminophen in the treatment of febrile children refers to 17-Sharivar Hospital of Rasht- Iran, 2008-9.
Public title
Comparison of usual versus high-dose rectal Acetaminophen in the treatment of febrile children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 6 months and 6 years, rectal temperature 39- 40.5ºc, No presence of any of the following conditions: gastroenteritis in the 24 hours prior to the study, any medical or surgical condition that precluded rectal drug administration, acute or chronic hepatic disease, rectal bleeding, malabsorption syndromes, acute or chronic renal disease with the exception of urinary tract infection, chronic metabolic disease, chronic neurological disease that may affect central thermoregulation, Febrile convulsion in the previous 6 hours, cancer, immune suppression, sepsis, critical medical status, Antipyretic administration in the previous 8 hours, Antibiotic administration within 12 hours prior to the initiation of the study until 3 hours afterwards, or known allergy to Acetaminophen Exclusion criteria: Ejection of Acetaminophen suppository within 30 minutes after administration, Development of allergy to Acetaminophen
Age
To 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical Faculty (Vice-chancellor of research, Guilan University of Medical Sciences-
Street address
Medical Faculty (Vice-chancellor of research)- Guilan University of Medical Sciences, Rasht, Guilan, Iran
City
Rasht
Postal code
Approval date
2008-09-14, 1387/06/24
Ethics committee reference number
473
Health conditions studied
1
Description of health condition studied
Fever in children
ICD-10 code
R50.9
ICD-10 code description
Fever, unspecified
Primary outcomes
1
Description
Rectal Temperature
Timepoint
One and three hour after acetaminophen administration
Method of measurement
Rectal digital thermometer- Microlife
Secondary outcomes
empty
Intervention groups
1
Description
Acetaminophen, 30mg/kg , suppositiry, single dose at the initiation of fever
Category
Treatment - Drugs
2
Description
Acetaminophen, 15mg/kg , suppositiry, single dose at the initiation of fever
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
17 Shahrivar Hospital of Rasht
Full name of responsible person
Dr. Houman Hashemian, M.D.
Street address
17 Shahrivar Hospital- Namjoo st., Rasht, Iran
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Houman Hashemian
Street address
17 Shahrivar Hospital, Namjoo st., Rasht, Iran
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan 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
Name of organization / entity
Guilan University of Medical Sciences- Medical Faculty- 17 Shahrivar Hospital of Rasht
Full name of responsible person
Dr. Houman Hashemian, M.D.
Position
Assistant Professor, Pediatric Infectious Diseases Subspecialist
Other areas of specialty/work
Street address
17 Shahrivar Hospital- Namjoo st. - Rasht- Iran
City
Rasht
Postal code
4144654839
Phone
+98 13 1322 6101
Fax
+98 13 1322 6101
Email
hashemian@gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medical Faculty, Guilan University of Medical Sciences- 17 Shahrivar Hospital of Rasht
Full name of responsible person
Dr. Houman Hashemian, M.D.
Position
Assistant Professor, Pediatric Infectious Diseases Subspecialist
Other areas of specialty/work
Street address
17 Shahrivar Hospital- Namjoo st. - Rasht- Iran
City
Rasht
Postal code
4144654839
Phone
+98 13 1322 6101
Fax
+98 13 1322 6101
Email
hashemian@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Medical Faculty, Guilan University of Medical Sciences, 17 Shahrivar Hospital of Rasht
Full name of responsible person
Dr. Houman Hashemian, M.D.
Position
Assistant Professor, Pediatric Infectious Diseases Subspecialist
Other areas of specialty/work
Street address
17 Shahrivar Hospital- Namjoo st. - Rasht- Iran
City
Rasht
Postal code
4144654839
Phone
+98 13 1322 6101
Fax
+98 13 1322 6101
Email
hashemian@gums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)