Determining the effect of low dose ketamine compared to methadone on pain control in addicts after surgery
Design
A clinical trial with a control group, parallel groups, single-blind, randomized, phase 2, 100 patients. Block method is used for randomization
Settings and conduct
Patients are referred to Imam Reza Hospital in Mashhad as candidates for abdominal surgeries.
At the end of the operation, after discontinuing all drugs, the ketamine group receives 0.5 mg per kg of ketamine every 6 hours intravenously and the methadone group receives 5 mg intramuscularly every 8 hours.
An anesthesia assistant or trained nurse accompanies the patient throughout the procedure and at the time of discharge. We will use the Verbal Scoring System (NRS) to assess pain. Patients are prescribed every 3 hours to record the pain score and at the end of 24 hours for the total morphine and the highest postoperative pain score is reported in the ICU. Also, in the questionnaire sheet, their pain number and if there are any side effects due to drugs or delirium due to ketamine will be recorded. This visit was performed by a person who will not be aware of the type of preoperative medication.
Participants/Inclusion and exclusion criteria
Addicted patients who are candidates for GA abdominal surgery who need ICU for postoperative period، Age between 20 to 65 years، History of daily drug use for the past 6 months
Intervention groups
Intervention group (Ketamine group): Ketamine in ICU 0.5 mg per kg every 6 hours intravenously and if there is a pain score greater than 3 is prescribed.
In the control group, 5 mg of methadone is administered every 8 hours.
Main outcome variables
Pain, time, gastrointestinal complications, respiratory apnea, hyperalgesia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111212008384N8
Registration date:2022-02-24, 1400/12/05
Registration timing:registered_while_recruiting
Last update:2022-02-24, 1400/12/05
Update count:0
Registration date
2022-02-24, 1400/12/05
Registrant information
Name
Arash Peivandi Yazdi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1852 5209
Email address
peivandia@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of analgesic effect of low dose of ketamine vs. methadone on opioid abusers undergoing surgery
Public title
Comparison of ketamine and methadone in pain control of addicts after surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Addicted patients who are candidates for GA abdominal surgery require special postoperative care
Age between 20 to 65 years
History of daily drug use for the past 6 months
Exclusion criteria:
Known drug allergy to ketamine or methadone History of hypertension or PAP
History of severe systemic disease
History of psychiatric illness
high ICP
History of alcohol and psychotropic substances
Prohibition of intramuscular injection
Pregnancy
Age
From 20 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
220
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization is used. In this method, 55 blocks of 4 are selected through the relevant sites. Then 110 letters A are prepared and 110 letters B are prepared. Opaque envelopes are also used for concealment. 220 envelopes are prepared and the letters A and B are placed in the extracted blocks, respectively. The envelopes are sealed and given to the patient's recipient. Each patient is given an envelope (in order) at the time of referral, which the patient will provide to the doctor. The letter A represents the methadone group and the letter B represents the ketamine group.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the person evaluating the amount of pain will be unaware of the allocating people in the two study groups.
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
Department of anesthesiology, Imam Reza hospital, Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Approval date
2021-01-19, 1399/10/30
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.150
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain
Timepoint
At the beginning, every 3 hours, after 24 hours
Method of measurement
Using the Verbal Scoring System (NRS) we will use zero as the minimum and 10 as the maximum number of pain.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Ketamine will be administered in the ICU 0.5 mg per kg every 6 hours intravenously
Category
Treatment - Drugs
2
Description
Control group: In the control group, 5 mg of methadone is administered every 8 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Arash Peivandi Yazdi
Street address
Department of anesthesiology, Imam Reza hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3854 3031
Email
PeivandiA@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Science
Full name of responsible person
Majid Ghayour Mobarhan
Street address
Ghoreishi apartment, Daneshgah street, Mashhad,
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Web page address
https://v-research.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Mashhad University of Medical Science
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
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Arash Peivandi Yazdi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Surgical Oncology Research Center, Imam Reza Hospital,Faculty of Medicine, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 1802 2677
Fax
Email
PeivandiA@mums.ac.ir
Web page address
http://www.mums.ac.ir/sorc
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Arash Peivandi Yazdi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Surgical Oncology Research Center, Imam Reza Hospital,Faculty of Medicine, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 1802 2677
Fax
Email
PeivandiA@mums.ac.ir
Web page address
http://www.mums.ac.ir/sorc
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Arash Peivandi Yazdi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Surgical Oncology Research Center, Imam Reza Hospital,Faculty of Medicine, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 1802 2677
Fax
Email
PeivandiA@mums.ac.ir
Web page address
http://www.mums.ac.ir/sorc
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
Data can potentially be shared after people are not identified
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
It will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
After correspondence with the scientific person in charge of the project and after the publication of the article, by preserving the intellectual rights of the authors, it is possible to access the data and perform analysis on the information.
From where data/document is obtainable
To request data, you can correspond by email to the person in charge of the scientific plan
What processes are involved for a request to access data/document
To request data, you can correspond by email to the person in charge of the scientific plan