Protocol summary

Summary
Aims: 1-to compare fever ocurrance in the first 24 hour after suregry in both groups. 2- to compare amountof rise in body temperature in the first 24 hour after surgery in both groups. Method: In this randomized, double-blind, placebo-controlled clinical, 80 children, aged 1-12years old, presenting for open heart surgery, were entered the trial and randomly allocated in to two groups: Placebo and Paracetamol. After induction of anaesthesia, 15mg/kg intravenous Paracetamol solution was infused during 1 hour in the Paracetamol group. Patients in placebo group received 15mg/kg normal saline infusion during the same time. Since the end of operation until next 24 hours in Intensive Care Unit, axillary temperature of the two group patients was recorded in four- hour intervals. Any fever occurred during this period, had been treated with Paracetamol suppository (125 mg) and the amount of antipyretic drug consumption for each patient had been recorded. In order to examine the safety of paracetamol, patients were evaluated for drug complication at the same time. Variables: primary outcome variables were fever ocurrance and mean body temperature rise in the first 24 hour after surgery. secondary outcome variables were drug side efeects and amount of extra antipyretic agent used. inclusion criteria: 1-12 year old children candidate for open heart surgery exclusion criteria: previous sensitivity to paracetamol, liver disease, renal disease

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201207215506N6
Registration date: 2012-09-24, 1391/07/03
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-09-24, 1391/07/03
Registrant information
Name
Mohamadhasan Abdollahi
Name of organization / entity
Yazd University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1826 0277
Email address
mhabdollahi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd University of Medical Sciences
Expected recruitment start date
2012-02-20, 1390/12/01
Expected recruitment end date
2012-07-04, 1391/04/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Intraoperative intravenous paracetamol administration on postoperative fever in pediatrics cardiac surgery
Public title
postoperative fever
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: children, aged 1-12years old, presenting for open heart surgery exclusion criteria: were history of previous sensitivity to paracetamol, liver and kidney disease
Age
From 1 year old to 12 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)
Double blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Yazd University of Medical Sciences Ethics Committee
Street address
Bahonar square
City
Yazd
Postal code
Approval date
2012-01-26, 1390/11/06
Ethics committee reference number
135684

Health conditions studied

1

Description of health condition studied
fever after cardiac surgery using cardiopulmonary pump
ICD-10 code
T88.8
ICD-10 code description
Other specified complications of surgical and medical care, not elsewhere classified

Primary outcomes

1

Description
Postoperative fever
Timepoint
In the 1st 24 hour after operation with 4 hour intervals.
Method of measurement
Trans-axillary

Secondary outcomes

1

Description
Paracetamol complications
Timepoint
24 hour after operation
Method of measurement
Study questionarie

Intervention groups

1

Description
intervention group: After induction of anaesthesia, 15mg/kg intravenous Paracetamol solution was infused during 1hour in the Paracetamol group
Category
Treatment - Drugs

2

Description
control group: Patients in placebo group received normal saline infusion with the same volume during the same time
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Afshar Heart Hospital
Full name of responsible person
Street address
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Hasan Mozaffari
Street address
Bahonar square
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hasan Abdollahi
Position
Assistant professor of anesthesiology department
Other areas of specialty/work
Street address
afshar hospital
City
Yazd
Postal code
Phone
+98 35 1826 0277
Fax
Email
mhabdollahi@yahoo.co.uk; mhabdollahi@yahoo.ssu.ac
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hasan Abdollahi
Position
Assiatant professor of anesthesiology department
Other areas of specialty/work
Street address
Afshar hospital
City
Yazd
Postal code
Phone
+98 35 1826 0277
Fax
Email
mhabdollahi@yahoo.co.uk; mhabdollahi@yahoo.ssu.ac
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hasan Abdollahi
Position
Anesthesiology professor
Other areas of specialty/work
Street address
Jomhoori blv., Afshar Heart hospital
City
Yazd
Postal code
Phone
Fax
Email
mhabdollahi@ssu.ac.ir
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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