Comparison of the effect of paracetamol and ketorolac on pain management in patients with non-synthetic opium abuse undergoing off pump Coronary artey bypass grafting
the objective of the study is to compare efficacy and complications of intravenous paracetamol and ketorolac for pain management of opium abusers undergoing CABG.
Design
In this RCT 100 patients with non-synthetic opium abuse scheduled for elective off-pump CABG are randomly (based on randomization number table) assigned to receive either paracetamol(n=50) or ketorolac (n=50).
Settings and conduct
The study will be conducated at postcardiac surgery ICU at Emam Reza hospital, Mashhad, Iran. In patients under mechanical ventilation, pain is assessed using CPOT score hourly. After weaning, NRS is used for pain evaluation every hour in the first 24 hours and every 4 hours on the second day. In case of pain, fentanyl 0.5 and 1 µg/kg every hour is used for for CPOT 3-5, and 6-8, respectively. Pain scores and fentanyl requirements are recorded and compared in the first and second 24 hours. Frequency of AKI and GI complications are explored. The patients, investigator, and data analyzers are blinded to the study.
Participants/Inclusion and exclusion criteria
adult patients with non-synthetic opium abuse undergoing elective CABG are recruited for the study. Patients with history of renal, gastrointestinal, or hepatic diseases, or bleeding are excluded from the study.
Intervention groups
The patients in the acetaminophen group will receive the drug 15 mg/kg at maximum 1 gram intravenously every 6 hours for 24 hours. The patients in the ketorolac group will receive the drug 0.5 mg/kg at maximum 60 mg intravenously every 6 hours for 24 hours.
Main outcome variables
pain score; amount of additional analgesic; frequency of AKI and GI complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150216021098N5
Registration date:2018-04-19, 1397/01/30
Registration timing:prospective
Last update:2018-04-19, 1397/01/30
Update count:0
Registration date
2018-04-19, 1397/01/30
Registrant information
Name
Shahram Amini
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3852 5209
Email address
aminish@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of paracetamol and ketorolac on pain management in patients with non-synthetic opium abuse undergoing off pump Coronary artey bypass grafting
Public title
Comparison of paracetamol and ketorolac on pain management in patients with opium abuse undergoing cardiac surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adult older than 18 years undergoing off-pupm CABG
ASA class 2 or 3
Non-synthetic opium abuse
Exclusion criteria:
Allergy to either of drugs
Consumption of either drugs in the past 48 hours
Preoperative use of nephrotoxic drugs
Presence of renal insufficiency or plasma creatinine higher than 1.3 mg/dL
History of gastrointestinal disease or bleeding, peptic ulcer, perioperative bleeding
Hepatic insufficiency
Ejection fraction less than 40%
Postoperative need for intraaortic ballon pump
perioperative hemodynamic compromise
Unwanter intraoperative events including arrhythmia or cardiac arrest
refusal to stay in the study
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The patients are randomly assigned to either group using randomization numbers table and will receive the intervention accordingly.
Blinding (investigator's opinion)
Triple blinded
Blinding description
After explaining the study method, interventions, and the administered drugs, the participants in either pararcetamol or ketorolac group, the outcome assessor, and the data analyzer will be blind to the administered drug.
The patients do not know which drug is going to be used.
The outcome assessors do not know which drug is going to be used.
The data analyzer does not know which drug is going to be used.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9791733135
Approval date
2017-12-13, 1396/09/22
Ethics committee reference number
IR.MUMS.fm.REC.1396.198
Health conditions studied
1
Description of health condition studied
Coronary artery bypass grafting
ICD-10 code
T82
ICD-10 code description
Complications of cardiac and vascular prosthetic devices, implants and grafts
Primary outcomes
1
Description
Pain intensity
Timepoint
every one and four hours in the first and second days, respectively after intervention
Method of measurement
Observation (CPOT0 and questioning (NRS) scores
Secondary outcomes
1
Description
Additional analgesic requirement
Timepoint
every one hour on the first day and every 4 hours on the second day
Method of measurement
Recording the amount of administered fentanyl in micro-gram
2
Description
Frequency of acute kidney injury
Timepoint
Every day after intervention until discharge from the hospital
Method of measurement
AKIN criteria
3
Description
Frequency of gastrointestinal bleeding and discomfort
Timepoint
every day after intervention until discharge from the hospital
Method of measurement
Observation and questioning
Intervention groups
1
Description
Intervention group 1: In the paracetamol group, the patients receive the drug 15 mg/kg at maximum 1 gram intravenously every 6 hours after arrival at ICU for 24 hours.
Category
Treatment - Drugs
2
Description
Intervention group 2: In ketorolac group, the patients receive the drug 0.5 mg/kg at maximum 60 mg intravenously every 6 hours after arrival at ICU for 24 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Shahram Amini
Street address
Ebne sina street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3180 2315
Fax
+98 51 3852 5209
Email
aminish@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
13131 - 91379.
Phone
+98 51 3841 2082
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Maragheh University of Medical Sciences
Full name of responsible person
Shahram Amini
Position
Profesor of anesthesiology and critical care
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Ebne sina street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316.
Phone
+98 51 3180 2315
Email
aminish@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shahram Amini
Position
Professor of anesthesiology and critical care
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesia, Imam Reza Hospital, Ibne Sina street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3852 5209
Fax
Email
Aminish@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
Shahram Amini
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Emam reza hospiral, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Phone
+98 51 3852 5209
Fax
Email
aminish@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available