Evaluation efficacy and side effects of IV ibuprofen and IV acetaminophen in pain control after laparoscopic cholecystectomy
Design
This multicenter, randomized, triple-blind, placebo-controlled trial was conducted in 90 patients.1-receive Fentanyl in the form of pain-pomp and IV placebo every 8 hours for 30 patients.2-receive Fentanyl and Ibuprofen 800 mg Iv every 8h for 30 patients. 3-receive Fentanyl and Acetaminophen 1g Iv every 8h for 30 patients. Randomization: sealed envelopes.
Settings and conduct
This trial was conducted in 90 patients scheduled to undergo elective laparoscopic cholecystectomy at Imam Khomeini hospital in Ardebil within 6 months. For all patients embedded patient-controlled analgesia pump and after surgery were randomly assigned in three groups:1-receive Fentanyl in the form of pain-pomp and IV placebo. 2-receive Fentanyl and Ibuprofen 800 mg IV. 3-receive Fentanyl and Acetaminophen 1g IV.
Participants/Inclusion and exclusion criteria
Non-entry points:
1-Pregnancy
2-Have a history of asthma and other respiratory disease
3-Have a history of heart failure
4-Have a history of CRF or dialysis
5-Have a history of GI bleeding
6-HTN
7-Have a history of Anemia
8-Patients are taking warfarin
9-Patients are taking a combination of ACEI and furosemide
10-Tolerance or dependence to opioids
11-Allergy or hypersensitivity to ibuprofen , ASA ,NSAIDs, or COX2 inhibitor
12-Age less than 20 years old and more than 60 years old
Intervention groups
1-receive Fentanyl (60 ml in 100cc N/S) in the form of pain-pomp and IV placebo every 8 hours for 30 patients.
2-receive Fentanyl and Ibuprofen 800 mg Iv every 8h for 30patients.
3-receive Fentanyl and Acetaminophen 1g Iv every 8h for 30 patients.
Main outcome variables
Choose the more effective and less side effective drugs to pain control
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161024030479N2
Registration date:2018-06-07, 1397/03/17
Registration timing:retrospective
Last update:2018-06-07, 1397/03/17
Update count:0
Registration date
2018-06-07, 1397/03/17
Registrant information
Name
Mahdiyeh Masoumzadeh
Name of organization / entity
Medical university of ardabil
Country
Iran (Islamic Republic of)
Phone
+98 914 357 8380
Email address
m.masom@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
2016-11-21, 1395/09/01
Actual recruitment end date
2017-05-21, 1396/02/31
Trial completion date
empty
Scientific title
Evaluation efficacy and side effects of IV ibuprofen and IV acetaminophen in pain control after laparoscopic cholecystectomy
Public title
Evaluation efficacy and side effects of IV ibuprofen and IV acetaminophen in pain control after laparoscopic cholecystectomy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients candidate for laparoscopic cholecystectomy
Age 20 - 60 years old
Exclusion criteria:
1-Pregnancy
Have a history of asthma and other respiratory disease
Have a history of heart failure
Have a history of CRF or dialysis
Have a history of GI bleeding
HTN
Have a history of Anemia
Patients are taking warfarin
Patients are taking a combination of ACEI and furosemide
Tolerance or dependence to opioids
Allergy or hypersensitivity to ibuprofen, ASA, NSAIDs, or COX2 inhibitor
Age less than 20 years old and more than 60 years old
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Sealed envelopes
Blinding (investigator's opinion)
Triple blinded
Blinding description
Prescribing medicine order the drug without information abute patient.Authorities collect data without informing the patient about the drug every six hours .Data evaluator is unaware about the type of drug given to each patient
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ardabil University of Medical Sciences
Street address
Ardabil University of Medical Sciences, Daneshgah st.
City
Ardabil
Province
Ardabil
Postal code
56189-85991
Approval date
2017-01-29, 1395/11/10
Ethics committee reference number
IR.ARUMS.REC.1395.89
Health conditions studied
1
Description of health condition studied
Cholecystit
ICD-10 code
K80
ICD-10 code description
Cholecystit
Primary outcomes
1
Description
Severity of pain in the surgical site
Timepoint
6, 12, 18 and 24 hours after surgery
Method of measurement
VAS system
Secondary outcomes
1
Description
Nausea and vomiting
Timepoint
6,12,18 and 24 hours after surgery
Method of measurement
N/V Score
2
Description
Shoulder pain
Timepoint
6,12,18 and 24 hours after surgery
Method of measurement
VAS
3
Description
Sedation
Timepoint
6,12,18 and 24 hours after surgery
Method of measurement
Ramsay score
Intervention groups
1
Description
First intervention group(control): for all patients embedded patient-controlled analgesia pump Fentanyl (60 ml in 100cc N/S) throughout the treatment period, patients also had access to Fentanyl (0.5 mg every 15 min) via patient-controlled analgesia or by patient request(PCA). Also receive IV placebo for a total of 3 doses:after the surgery, 8 and 16h after surgery.
Category
Placebo
2
Description
Second intervention group: embedded patient-controlled analgesia pump like control group and receive IV acetaminophen 1g for a total of 3 doses:after the surgery, 8 and 16h after surgery.
Category
Treatment - Drugs
3
Description
Third intervention group: embedded patient-controlled analgesia pump like control group and receive IV Ibuprofen 800mg for a total of 3 doses:after the surgery, 8 and 16h after surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital in Ardabil
Full name of responsible person
Dr Ali Mohammadian Erdi
Street address
Imam Khomeini Hospital, Shahidan noiaghdam street
City
Ardabil
Province
Ardabil
Postal code
85991_56189
Phone
+98 45 3325 1401
Fax
+98 45 3326 2140
Email
Emamhe@arums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Ali Mohammadian Erdi
Street address
Ardabil University of Medical Sciences, Daneshghah st.
City
Ardabil
Province
Ardabil
Postal code
85991_56189
Phone
+98 45 3352 2247
Fax
+98 45 3352 2196
Email
Info@arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Ali Mohammadian Erdi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini Hospital in Ardabil
City
Ardabil
Province
Ardabil
Postal code
56189-85991
Phone
+45 33 33 00 64
Fax
Email
masoumzadeh.med@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Ali Mohammadian Erdi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ardabil University of Medical Sciences, Daneshghah st.
City
Ardabil
Province
Ardabil
Postal code
56189-85991
Phone
+98 45 3352 2076
Fax
Email
a.mohammadian@arums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Mahdiyeh Masoumzadeh
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
Medical Education
Street address
Ardabil University of Medical Sciences, Daneshghah st.
City
Ardabil
Province
Ardabil
Postal code
56189-85991
Phone
+98 45 3333 0064
Fax
Email
masoumzadeh.med@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
Title and more details about the data/document
all the data will be publish After identifying people.name:Evaluation efficacy and side effects of IV ibuprofen and IV acetaminophen in pain control after laparoscopic cholecystectomy
When the data will become available and for how long
it Is accessible 3 months after printing results
To whom data/document is available
Every researcher In all disciplines can receive the information .
Under which criteria data/document could be used
If the data is useful for another study,Available to anyone specializing in this field.
From where data/document is obtainable
Responsive person is Mahdiyeh masoumzadeh with this way:
masoumzadeh.med@gmail.com
What processes are involved for a request to access data/document
If the request is submitted to the email address, and the full introduction and explanation of the reason for the request,The data is sent within a week.