The aim of this study is to evaluate the effect of oral and injectable acetaminophen for pain control after cardiac surgery. Study design randomly. The study population is all patients will be undergoing cardiac surgery at the Madani hospital Khormmabad. Such as the includ criteria to participate in this study, all patients undergoing CABG surgery with or without valve replacement. Also who have no history of addiction to drugs and alcohol as well as renal and hepatic failure. Such as the exclusion criteria of this study, the patient's pain score greater than 7 and not wanting to continue cooperation. The sample size for each group of 40 people and all sample 160 people was calculated. Available sampling will be done using four blocks. Patients in group A received acetaminophen injection every 6 hours, and if continues pain will be administered pethedine. Patients in group B if have pain will be received acetaminophen injection, and if continues pain will be administered pethedine. Patients in group C patients received oral acetaminophen every 6 hours, and if continues pain will be administered pethedine. Patients in group D if have pain will be received oral acetaminophen, and if continues pain will be administered pethedine. Start time the study that patients were extubated and are fully alert and awake. For assessment of pain will be used visual analog scale. Pain at the time of 0, 20, 80, 120 minutes after receiving the first dose and during deep breathing and coughing, will be checked. The level of pain and opioid consumption in the four groups will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016022026217N2
Registration date:2016-03-16, 1394/12/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-03-16, 1394/12/26
Registrant information
Name
Sajad Yarahmadi
Name of organization / entity
Iran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 3322 5655
Email address
yarahmadi.s@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Lorestan University of Medical Sciences
Expected recruitment start date
2016-09-06, 1395/06/16
Expected recruitment end date
2017-02-04, 1395/11/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect and comparison of oral and intravenous Acetaminophen in pain control and Consumption opioid in post cardiac surgery patients
Public title
The effect and comparison of oral and intravenous Acetaminophen in pain cardiac surgery patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all patients who underwent CABG surgery with or without valve replacement; age older than 18 or less than 65 years; absence of addiction to drugs or alcohol; absence of allergy or hypersensitivity to acetaminophen or narcotics; absence of impaired kidney function (creatinine level Less than 2 milligrams per deciliter); no history of liver failure; no history of sleep apnea. Exclusion criteria: Visual analog scale score is higher than 7 after extubation; not wanting to continue cooperation؛; use of narcotic drugs and sedatives during the procedure؛; decreased level of consciousness of the patient during the study.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Selected by sampling and random assignment method.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Lorestan University of Medical Sciences
Street address
km 5 Road of Khorram Abad - Boroujerd - opposite to the Kahrizak village- Integrated Lorestan Medical Sciences
City
Khoramabad
Postal code
Approval date
2015-11-25, 1394/09/04
Ethics committee reference number
LUMS.REC.1394.41
Health conditions studied
1
Description of health condition studied
Coronary and valvular heart surgery
ICD-10 code
I97.1
ICD-10 code description
Other functional disturbances following cardiac surgery
Primary outcomes
1
Description
Amount of pain
Timepoint
Minute 0, 20, 80 and 120 after receiving the first dose
Method of measurement
visual analog scale
2
Description
The amount of narcotic
Timepoint
24 hours after receiving the first dose
Method of measurement
Milligrams per kilogram of body weight
Secondary outcomes
1
Description
The best pattern of use drug on regular basis or on when necessary
Timepoint
24 hours after receiving the first dose
Method of measurement
Visual anlog scale and milligrams per kilogram of body weight
2
Description
Nausea
Timepoint
frequency during the first 24 hours after receiving the first dose
Method of measurement
history taking from patient or nurses
3
Description
Vomiting
Timepoint
frequency during the first 24 hours after receiving the first dose
Method of measurement
history taking from patient or nurses
4
Description
need for antiemetics
Timepoint
frequency during the first 24 hours after receiving the first dose
Method of measurement
information taken from patient's records
Intervention groups
1
Description
Patients in group A received acetaminophen injection every 6 hours, and if continues pain will be administered pethedine.
Category
Treatment - Drugs
2
Description
Patients in group B if have pain will be received acetaminophen injection, and if continues pain will be administered pethedine.
Category
Treatment - Drugs
3
Description
Patients in group C received oral acetaminophen every 6 hours, and if continues pain will be administered pethedine.
Category
Treatment - Drugs
4
Description
Patients in group D if have pain will be received oral acetaminophen, and if continues pain will be administered pethedine.