The Effect of Ondansetron on Acetaminophen's analgesic power
Design
A double-blinded, parallel-group clinical trial with random sampling and allocation in intervention and control group
Settings and conduct
An available double-blinded sampling will be conducted on patients referred to the central operating room of Qaem Hospital, Mashhad. They will be all candidates of Laparoscopic Cholecystectomy surgery with GA. Neither analyst nor participant will be informed about group allocation. At the last 30 minutes of the surgery, In the first intervention group 1000 mg acetaminophen infusion and 4 mg of ondansetron will be injected and In the second intervention group, 1000 mg acetaminophen infusion and 8 mg of ondansetron will be injected. at the last 30 minutes of the surgery In the control group, 1000 mg acetaminophen infusion and 10 mg of metoclopramide will be injected.Checklist variables are recorded (pain, nausea and The postoperative analgesic consumption).
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1 & 2 ASA class, Age of 18-64, Speak Persian
Exclusion criteria: addiction, taking analgesic drugs within the last 24 hours, taking ondansetron or metoclopramide within the last 24 hours, chronic pain, history of Drug allergy, history of Psychological disease
Intervention groups
At the last 30 minutes of the surgery, In the first intervention group 1000 mg acetaminophen infusion and 4 mg of ondansetron will be injected and In the second intervention group, 1000 mg acetaminophen infusion and 8 mg of ondansetron will be injected. at the last 30 minutes of the surgery In the control group, 1000 mg acetaminophen infusion and 10 mg of metoclopramide will be injected.
Main outcome variables
Acetaminophen's analgesic effect
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160516027925N4
Registration date:2019-07-06, 1398/04/15
Registration timing:registered_while_recruiting
Last update:2019-07-06, 1398/04/15
Update count:0
Registration date
2019-07-06, 1398/04/15
Registrant information
Name
Amir Zoka
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3822 4395
Email address
zokaa921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-11-21, 1398/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Ondansetron on Acetaminophen's analgesic power in Cholecystectomy Patients
Public title
The Effect of Ondansetron on Acetaminophen's analgesic power
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
1 & 2 ASA class
Age of 18-64
Being able to speak and understand Persian
Exclusion criteria:
history of Psychological disease
history of Ondansetron & Acetaminophen allergy
any chronic pain in part's of the body
taking ondansetron or metoclopramide within the last 24 hours
taking any analgesic drugs within the last 24 hours
alcohol & drug addiction
Age
From 18 years old to 64 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be assigned to the control or intervention group by drawing a random number out of a bag
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will not be informed about which group they are in. Also, the data analyst will be blind to which group the participants are assigned
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
Knowledge and Health City, In the end of Shahid Fakouri Blvd, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2018-12-04, 1397/09/13
Ethics committee reference number
Ir.mums.medical.rec.1397.593
Health conditions studied
1
Description of health condition studied
The Effect of Ondansetron on Acetaminophen's analgesic power in Cholecystectomy Patients
ICD-10 code
Y57.9
ICD-10 code description
Drug or medicament, unspecified
Primary outcomes
1
Description
Acetaminophen's analgesic power
Timepoint
After surgery in recovery, One hour after surgery in recovery, Six hours after surgery in the ward
Method of measurement
Numerical Rating Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: At the last 30 minutes of the surgery,1000 mg acetaminophen infusion and 4 mg of ondansetron will be injected
Category
Prevention
2
Description
Intervention group: At the last 30 minutes of the surgery, 1000 mg acetaminophen infusion and 8 mg of ondansetron will be injected.
Category
Prevention
3
Description
Control group: at the last 30 minutes of the surgery, 1000 mg acetaminophen infusion and 10 mg of metoclopramide will be injected.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Qaem hospital
Full name of responsible person
Mohsen Sabermoghaddam
Street address
Ahmadabad Blvd, Mashhad, Razavi Khorasan Province
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3840 0000
Email
zoka.am69@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Saed Eslami
Street address
Knowledge and Health City, In the end of Shahid Fakouri Blvd, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3840 0000
Email
sabermoghaddamm@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
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Amir Zoka
Position
Academic instructor
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Torbat Heydariyeh University of Medical Sciences, Qarani Blvd, Torbat Heydariyeh, khorasan Razavi
City
Mahshad
Province
Razavi Khorasan
Postal code
9516915169
Phone
+98 51 5222 6011
Fax
+98 51 3822 4395
Email
zokaa1@thums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Amir Zoka
Position
Academic instructor
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Torbat Heydariyeh University of Medical Sciences, Qarani Blvd, Torbat Heydariyeh, khorasan Razavi
City
Mahshad
Province
Razavi Khorasan
Postal code
9516915916
Phone
+98 51 5222 6011
Fax
+98 51 3822 4395
Email
zokaa1@thums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Amir Zoka
Position
Academic instructor
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Torbat Heydariyeh University of Medical Sciences, Qarani Blvd, Torbat Heydariyeh, khorasan Razavi
City
Mahshad
Province
Razavi Khorasan
Postal code
092111111111
Phone
+98 51 3822 4395
Fax
+98 51 3822 4395
Email
zokaa1@thums.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
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All de-identified individual participant data will be shared. Both of the entire study protocol and informed consent of the participants in the study are shared too.
When the data will become available and for how long
6 months after the publication of the article
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Given the patient's satisfaction to participate in this study, the data should only be used for similar studies
From where data/document is obtainable
Email to the authors Sabermoghaddamm@mums.ac.ir Zokaa1@thums.ac.ir
What processes are involved for a request to access data/document
After the email, the request will be made available to the authors to reach the requesting person within a maximum of one month if the conditions are confirmed.