Protocol summary

Study aim
Comparing the effect of dextromethorphan with ketamine in relieving pain after abdominal surgery in Islamic Azad University hospitals in 2021-2022
Design
Phase 2 double-blind randomized clinical trial with a sample size of 46 patients
Settings and conduct
In this study, which was conducted in the form of a clinical trial, 46 patients who were candidates for abdominal surgery, who were randomly selected from Bu Ali Hospital, were included in the study and randomly using block randomization, accessible and double-blind, that neither people nor technicians who It records people's information, they don't know about the type of drug they received, they were placed in two groups receiving ketamine and dextromethorphan. He does not know, he records the information and at the end of the work, the student collected the recorded information. Demographic information of patients such as age, gender and clinical information such as type of surgery, pain intensity before surgery, one hour, 4 hours, 8 hours and 12 hours after recovery were recorded. After the operation, at the time of requesting analgesia, he was treated with intravenous meperidine, and at the time of requesting analgesia and expressing pain, pain intensity was recorded and compared using the VAS method. Then the obtained information was entered into SPSS software version 26 and the result and statistical analysis was done based on the nature of the variables.
Participants/Inclusion and exclusion criteria
Entry requirements: patients who are candidates for abdominal surgery; lack of drug sensitivity to the drugs used; ASA one and two. Exit conditions: BMI less than 20 to more than 30; patients with age above 70 years old; reluctance to continue participation; occurrence of problems during surgery.
Intervention groups
Two groups receiving ketamine and dextromethorphan
Main outcome variables
Pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230303057595N1
Registration date: 2023-03-14, 1401/12/23
Registration timing: retrospective

Last update: 2023-03-14, 1401/12/23
Update count: 0
Registration date
2023-03-14, 1401/12/23
Registrant information
Name
Shahin Rashvand Haranaki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3457 1005
Email address
rashvandshahin@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-21, 1400/01/01
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
2022-03-21, 1401/01/01
Actual recruitment end date
2022-03-21, 1401/01/01
Trial completion date
2022-03-21, 1401/01/01
Scientific title
Comparing the effect of dextromethorphan with ketamine in relieving pain after abdominal surgery in Islamic Azad University hospitals in 2021-2022
Public title
Comparing the effect of dextromethorphan with ketamine in relieving pain after abdominal surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are candidates for abdominal surgery Lack of drug sensitivity to the drugs used ASA 1,2
Exclusion criteria:
BMI less than 20 to more than 30 Patients with age above 70 years Unwillingness to continue participation Occurrence of problems during surgery
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 46
Actual sample size reached: 46
Randomization (investigator's opinion)
Randomized
Randomization description
The patients were randomly assigned to two groups receiving ketamine and dextromethorphan using block randomization and available and double-blind, in which neither the subjects nor the technician who records the information of the subjects know the type of drug received.
Blinding (investigator's opinion)
Double blinded
Blinding description
People do not know which treatment group they are placed in, and also an impartial technician who does not know the type of treatment of each person records the information and at the end of the student's work, she collected the recorded information.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran Islamic Azad University of Medical Sciences
Street address
Tehran, Doktor Shariati St., Golhak Do Rahi, Amir Pabarja St., Aine Blvd., Corner of Gol Yakh St., Headquarters Building of Tehran Islamic Azad University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1949635881
Approval date
2022-09-19, 1401/06/28
Ethics committee reference number
IR.IAU.TMU.REC.1401.201

Health conditions studied

1

Description of health condition studied
Abdominal surgery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain by Visual Analogue Scale
Timepoint
Before the operation, one hour, 4 hours, 8 hours and 12 hours after recovery
Method of measurement
VAS

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Ketamine receiving group
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University Hospitals (Boali, Amirul Mominin, Farhikhtegan)
Full name of responsible person
Giti Dehghan Manshad
Street address
Tehran, Doktor Shariati St., Golhak Do Rahi, Amir Pabarja St., Aine Blvd., Corner of Gol Yakh St., Headquarters Building of Tehran Islamic Azad University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
rashvandshahin@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farshad Hashemian
Street address
Tehran, Doktor Shariati St., Golhak Do Rahi, Amir Pabarja St., Aine Blvd., Corner of Gol Yakh St., Headquarters Building of Tehran Islamic Azad University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
rashvandshahin@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Shahin Rashund Hranki
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Tehran, Doktor Shariati St., Golhak Do Rahi, Amir Pabarja St., Aine Blvd., Corner of Gol Yakh St., Headquarters Building of Tehran Islamic Azad University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
rashvandshahin@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shahin Rashund Hranki
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Tehran, Doktor Shariati St., Golhak Do Rahi, Amir Pabarja St., Aine Blvd., Corner of Gol Yakh St., Headquarters Building of Tehran Islamic Azad University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
rashvandshahin@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shahin Rashund Hranki
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Tehran, Doktor Shariati St., Golhak Do Rahi, Amir Pabarja St., Aine Blvd., Corner of Gol Yakh St., Headquarters Building of Tehran Islamic Azad University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
rashvandshahin@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
No - There is not a plan to make this available
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