Determining the effect of intramuscular methadone injection on pain relief after kidney transplant surgery in recovery and ward
Design
A double-blind randomized clinical trial with control group, and parallel groups, phase 3-2 on 35 patients. Excel software was used to randomize.
Settings and conduct
A double blind clinical trial study on renal failure patients was performed at Sinai Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: all patients with renal failure candidate for kidney transplant surgery aged 20-55 years old.
Exclusion criteria: history of drugs addiction, methadone use; neurological or psychiatric drugs; asthma, seizure and prolonged QT interval in EKG.
Intervention groups
Intervention group: after induction of anesthesia, 5 mg of methadone is injected intramuscularly with a 2 cc syringe. At the end of anesthesia, all patients received 1 gram of intravenous acetaminophen and after endotracheal extubation, pain intensity and agitation of patients in recovery and in the ward at 6, 12, 18 and 24 hours after entering the ward are evaluated. The total amount of analgesic requirement are evaluated during 24 hours after surgery.
Control group: They received morphine 5 mg intramuscularly with a 2 cc syringe. At the end of anesthesia, all patients received 1 gram of intravenous acetaminophen and after endotracheal extubation, pain intensity and agitation of patients in recovery and in the ward at 6, 12, 18 and 24 hours after entering the ward are evaluated. The total amount of analgesic requirement are evaluated during 24 hours after surgery.
Main outcome variables
Incidence and severity of pain and agitation after kidney transplant surgeries
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130304012695N9
Registration date:2021-04-30, 1400/02/10
Registration timing:registered_while_recruiting
Last update:2021-04-30, 1400/02/10
Update count:0
Registration date
2021-04-30, 1400/02/10
Registrant information
Name
mohammadreza khajavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6312 1220
Email address
khajavim@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-30, 1400/02/10
Expected recruitment end date
2022-02-19, 1400/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of postoperative analgesic effect of Intra muscular injection of methadon after induction of anesthesia in Renal Transplantation Surgery.
Public title
Reduction of pain of renal transplantation surgeries
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Renal failure candidate for renal transplant
Exclusion criteria:
History of drug addiction and methadone use
History of neural or psychiatric drugs
History of asthma or seizure
Prolonged QT interval in EKG
Age
From 20 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
To randomize patients with inclusion criteria, block balanced randomization is used. Before studying, one of the person who is not a member of the research team performs the randomization process by using Random generator software, forms four blocks for the intervention and control group. The complete cards of the four blocks are given to the head of the operating room, who is unaware of the study, in an envelope. A card is given to the patient after patient entrance to operating room.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants: since patients are not aware of the type of study drug at the time of anesthesia induction they were blind about the group to which they were allocated.
Those who evaluate the outcome: the assistant who records the results in this study does not know the type of group.
Data collection officials: the person who analyzes the data also does not know the type of participating groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the School of Medicine, Tehran University of Medical Sciences
Street address
Sina hospital, Hasan Abad Sq., Emam Khomeni st.
City
Tehran
Province
Tehran
Postal code
1136746911
Approval date
2021-04-21, 1400/02/01
Ethics committee reference number
IR.TUMS.SINAHOSPITAL.REC.1400.013
Health conditions studied
1
Description of health condition studied
Abdominal Acute Pain after renal transplant surgery
ICD-10 code
R10.0
ICD-10 code description
Acute abdomen
2
Description of health condition studied
Postoperative stress and agitation
ICD-10 code
F43.0
ICD-10 code description
Acute stress reaction
Primary outcomes
1
Description
Incidence and severity of abdominal pain
Timepoint
post extubation in recovery and 6,12,18 and 24 hours after surgery in ward
Method of measurement
Visual Analogue Scale
2
Description
Severity of postoperative agitation
Timepoint
Ramsy sedation Scale
Method of measurement
Post extubation in recovery and 6,12,18 and 24 hours after surgery in ward
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: after induction of anesthesia 5mg methadone intranuscularly was injected .After extubation, incidence and severity of abdominal pain and degree of agitation and total amount of analgesic consumption in in recovery and ward and 24 hours after surgery are evaluated
Category
Treatment - Devices
2
Description
Control group: after induction of anesthesia 5mg morphine intranuscularly was injected .After extubation, incidence and severity of abdominal pain and degree of agitation and total amount of analgesic consumption in in recovery and ward and 24 hours after surgery are evaluated
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Mohammad Reza Khajavi
Street address
Sina Hospital Imam khomeini st
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8550
Email
khajavim@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraeian
Street address
Central building of Tehran University of Medical sciences, Ghods st., Keshavarz blv.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohammadreza Khajavi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sina Hospital Imam Khomeini
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 1220
Fax
+98 21 6312 0000
Email
khajavim@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadreza Khajavi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sina Hospital Imam Khomeini
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 1220
Fax
+98 21 6312 0000
Email
khajavim@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadreza Khajavi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sina Hospital Imam Khomeini st
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 1220
Fax
+98 21 6312 0000
Email
khajavim@tums.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
All information used for this research can be shared after unidentified the identity of patients. Also, statistical information, information analysis, study method, findings and conclusions can be shared.
When the data will become available and for how long
Starting access after accepting by a valid scientific journal and publishing it
To whom data/document is available
For academic researchers and in the field of science
Under which criteria data/document could be used
All researchers can use all published material and if all or part of this research is published by other people, the name and source of this research and its researchers should be mentioned.
From where data/document is obtainable
Mohammad Reza Khajavi
What processes are involved for a request to access data/document
The applicant can request the type of files by email.
khajavim@tums.ac.ir