Purpose: Clinical trial comparing effect of Paracetamol and Ketorolac on pain management after cardiac surgery in children. Design and criteria: This study is prospective, randomized and double blinded clinical trial. Researchers and patient were blind about the type of drugs. Patients in this study were randomly divided into two groups. In group 1 (n=40) to reduce pain was used Paracetamol a dose of 15 mg per kg every 6 hours for 48 hours, and in group 2 (n=40) to reduce pain was used ketorolac 0.5 mg per kg every 6 hours for 48 hours. Inclusion criteria: All patients undergoing cardiac surgery; children between the age of 12-2 years. Exclusion criteria: patient dissatisfaction; addiction; drug allergy. Ketorolac groups: patients with renal insufficiency. Paracetamol group having allergies; liver failure; renal failure. Intervention group 1 : Paracetamol as commercial name Apotel made by Couble drug company with dose of 15 mg per kg every 6 hours was used for 48 hours. Intervention group 2 : Ketorolac intravenous with dose of 0.5 mg every 6 hours made by Exir company was used for 48 hours. Primary outcome 1 : Pain. Primary outcome time point: Every 1 hour to 24 hours after the second day every 4 hours for 48 hours Primary outcome method of measurement: CPOT (Critical-care Pain Observation Tool)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015012320759N1
Registration date:2015-09-15, 1394/06/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-09-15, 1394/06/24
Registrant information
Name
Ghasem Soltani
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3852 5209
Email address
soltanigh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad University of Medical Science
Expected recruitment start date
2014-08-06, 1393/05/15
Expected recruitment end date
2015-02-09, 1393/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Paracetamol and Ketorolac on pain management after cardiac surgery in children
Public title
Clinical trial comparing effect of Paracetamol and Ketorolac on pain management after cardiac surgery in children
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: All patients undergoing cardiac surgery; children between the age of 12-2 years. Exclusion criteria: patient dissatisfaction; addiction; drug allergy. Ketorolac groups: patients with renal insufficiency. Parecetamol group having allergies; liver failure; renal failure
Age
From 91 years old to 81 years old
Gender
Both
Phase
3
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
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Ghoreishi apartment, Daneshgah street, Mashhad
City
Mashhad
Postal code
Approval date
2014-07-26, 1393/05/04
Ethics committee reference number
930142
Health conditions studied
1
Description of health condition studied
Precordial pain
ICD-10 code
R07.2
ICD-10 code description
Precordial pain
Primary outcomes
1
Description
Pain
Timepoint
Every 1 hour to 24 hours after the second day every 4 hours for 48 hours
Method of measurement
CPOT (Critical-care Pain Observation Tool)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1 : Paracetamol as commercial name Apotel made by Couble drug company with dose of 15 mg per kg every 6 hours was used for 48 hours.
Category
Treatment - Drugs
2
Description
Intervention group 2 : Ketorolac intravenous with dose of 0.5 mg per kg every 6 hours made by Exir company was used for 48 hours.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr Ghasem Soltani
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Science
Full name of responsible person
Hamid Eslami
Street address
Ghoreishi apartment, Daneshgah street, Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Mashhad University of Medical Science
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
Mashhad University of Medical Science
Full name of responsible person
Dr Ghasem Soltani
Position
Associate Professor
Other areas of specialty/work
Street address
Department of Anesthesia, Imam Reza Hospital, Ibne Sina st, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3852 5209
Fax
Email
Soltanigh@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University Of Medical Sciences
Full name of responsible person
Dr Ghasem Soltani
Position
Associate Professor
Other areas of specialty/work
Street address
Department of Anesthesia, Imam Reza Hospital, Ibne Sina street, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3852 5209
Fax
Email
Soltanigh@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Ghasem Soltani
Position
Associate Professor
Other areas of specialty/work
Street address
Department of Anesthesia, Imam Reza Hospital, Ibne Sina Street, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3852 5209
Fax
Email
Soltanigh@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)