The effect of paracetamol, metoclopramide and combination of metoclopramide and paracetamol on pain severity after laparoscopic cholecystectomy and comparison with control group
Determining the effect of Paracetamol, Metoclopramiode and combination of Metoclopramide and Paracetamol on pain severity after laparoscopic cholecystectomy and comparison with control group
Design
Clinical trial with control group, with parallel groups, randomized
Settings and conduct
The study was conducted in 1396-1397 in Al-Zahra Hospital , Isfahan. The target population are the patients who referred to Al-Zahra hospital for elective laparoscopic cholecystectomy.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients aged 18-65 year referred to Al-Zahra hospital during the year 1396-1397 for elective laparoscopic cholecystectomy and classified as ASA physical status 1 or 2 were included
Exclusion criteria: Pregnancy, Addiction to cigarette, opioid and alcohol, Weight over 100 kg, Chronic pain that lasts more than 6 months,Allergy to Metoclopramide or Acetaminophen, Anxiety before surgery, Taking any analgesic 24 hours before surgery
Intervention groups
In this clinical trial study, 100 patients undergoing laparoscopic cholecystectomy surgery referred to Alzahra Hospital in Isfahan were enrolled from 2015 to 2017. Patients were randomly divided into four groups receiving 15 mg/kg paracetamol or 0.15 mg/kg metoclopramide or 10 mg/kg paracetamol and 0.1 mg/kg metoclopramide or placebo. pain severity and hemodynamic variables were assessed in the groups.
Main outcome variables
Severity of pain؛ Hemodynamic variables
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190825044610N1
Registration date:2019-09-14, 1398/06/23
Registration timing:retrospective
Last update:2019-09-14, 1398/06/23
Update count:0
Registration date
2019-09-14, 1398/06/23
Registrant information
Name
Seyyede Hosna Mirzajjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3673 0416
Email address
hosnamirzajani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
2017-08-23, 1396/06/01
Actual recruitment end date
2018-12-03, 1397/09/12
Trial completion date
2018-12-03, 1397/09/12
Scientific title
The effect of paracetamol, metoclopramide and combination of metoclopramide and paracetamol on pain severity after laparoscopic cholecystectomy and comparison with control group
Public title
The effect of paracetamol and metoclopramide on postoperative pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18-65 year referred to Al-Zahra hospital during the year 1396-1397 for elective laparoscopic cholecystectomy and classified as ASA physical status 1 or 2 were included
Exclusion criteria:
Pregnancy
Addiction to cigarette, opioid and alcohol
Weight over 100 kg
Chronic pain that lasts more than 6 months
Allergy to metoclopramide or acetaminophen
Anxiety before surgery
Taking any analgesic 24 hours before surgery
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple randomization
Randomization unit: Individual
Randomization layer: Not done
Randomization tool: Random number table
How to create random sequence: Classification in groups like this:
Group A: 1-25
Group B: 26-50
Group C: 51-75
Group D: 76-100
Allocation concealment: Using numbered drug containers
Blinding (investigator's opinion)
Double blinded
Blinding description
A person who inject drugs is different from person who collect data
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Comittee of Isfahan University of Meical Science
Street address
Isfahan University of Medical Science, Hezar Jarib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Approval date
2018-01-17, 1396/10/27
Ethics committee reference number
IR.MUI.MED.REC.1397.120
Health conditions studied
1
Description of health condition studied
Postoperative pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Severity of postoperative pain
Timepoint
In extubation time,15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 8 hours,16 hours and 24 hours after operation
Method of measurement
Questionnaire according to Visual Analogue Scale
Secondary outcomes
1
Description
Blood pressure
Timepoint
In extubation time, 15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 8 hours, 16 hours and 24 hours after operation
Method of measurement
Manometer
2
Description
Pulse Rate
Timepoint
In extubation time, 15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 8 hours, 16 hours and 24 hours after operation
Method of measurement
Pulseoxymeter
Intervention groups
1
Description
Intervention group 1: Intravenous injection of 15mg/kg paracetamol in 20 cc normal saline
Category
Treatment - Drugs
2
Description
Intervention group 2: Intravenous injection of 0.15mg/kg metoclopramide in 20 cc normal saline
Category
Treatment - Drugs
3
Description
Intervention group 3: Intravenous injection of 0.10mg/kg metoclopramide and 10mg/kg paracetamol in 20 cc normal saline
Category
Treatment - Drugs
4
Description
Control group: Intravenous injection in 20 cc normal saline
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Medical Center, Isfahan
Full name of responsible person
Hamid Haji Gholam Saryazdi
Street address
Isfahan Univesity of Medical Science, Hezar Jarib Street, Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3673 0416
Email
haji@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Isfahan University of Medical Science, Hezar Jarib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3673 0416
Email
haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Hamid Haji Gholam Saryazdi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Isfahan University of Medical Science, Hezar Jarib Street, Isfahan,Iran,
City
Isfahan
Province
Isfehan
Postal code
8974675731
Phone
+98 31 3673 0416
Email
Haji@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamid Haji Gholam Saryazdi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Isfahan University of Medical Science, Hezar Jarib Stret, Isfahn, Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3673 0416
Email
Haji@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamid Haji Gholam Saryazdi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Isfahan University of Medical Science, Hezar Jarib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3673 0416
Email
Haji@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Whole data will be available
When the data will become available and for how long
Immediately after publishing manuscript
To whom data/document is available
To whom is in need to this data
Under which criteria data/document could be used
Email to Dr Hamid Haji Gholam Saryazdi
Email: haji@med.mui.ac.ir
From where data/document is obtainable
Dr Hamid Haji Gholam Saryazdi
What processes are involved for a request to access data/document
Email to Dr Hamid Haji Gholam Saryazdi
Email: haji@med.mui.ac.ir