Determining and comparing the effect of methadone and morphine on pain after rhinoseptoplasty surgery
Design
In the main and studied group, the desired dose of the drug is 0.15 mg per body weight (ideal weight). Methadone is administered slowly intravenously half an hour after the start of surgery. In the study group, the desired dose of the drug was 0.15 mg per body weight (ideal weight). Morphine is administered slowly intravenously half an hour after surgery.
Settings and conduct
This study is conducted in a double-blind manner, that is, patients, doctors, caregivers, and statistical analysts will not know about the allocation of groups to reduce bias.
. During the operation, hemodynamic variables were recorded and recorded with the results. We compare the results of the control group. In case and control groups, follow-up, study and recording of variables identified at the end of surgery and patient extubation and recovery and 1 and 6 hours after surgery by the researcher include: variables such as nausea and vomiting and bleeding, the amount of analgesic and sedative use, headache and severity Postoperative pain (according to the VAS table) and using the pain observation scale, the frequency of headache, postoperative nausea and vomiting and the amount of analgesia used 6 hours after surgery will be evaluated and then compared.
Participants/Inclusion and exclusion criteria
Candidate patients for rhinoplasty surgery
ECG normal and (no long QT)
Intervention groups
In the main and studied group, the desired dose of the drug is 0.15 mg per body weight (ideal weight). Methadone is administered slowly intravenously half an hour after the start of surgery.
Main outcome variables
Intensity of pain/ Hemodynamics
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220517054884N1
Registration date:2023-08-13, 1402/05/22
Registration timing:retrospective
Last update:2023-08-13, 1402/05/22
Update count:0
Registration date
2023-08-13, 1402/05/22
Registrant information
Name
Vahid Damanpak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3721 1301
Email address
educationmo110@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-10, 1401/03/20
Expected recruitment end date
2023-03-23, 1402/01/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study Intraoperative methadone and morphin for postoperative pain after rhinoseptoplasty
Public title
Comparison of the effect of methadone and morphine on pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate patients for rhinoseptoplasty surgery
Normal EKG and (no long QT)
Exclusion criteria:
Drug addiction
History and psychological illness
Patient dissatisfaction
History of drug allergy to previous surgeries
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
182
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is performed using random block allocation with 4 blocks, which have all four modes A, A, B, B, AA B, B B A A and B A A B A, A B B A, B A A A B, written in 6 cards and The first four patients are randomly grouped. The ward manager takes the patient card out of the bag and the patients are divided into groups by lot. For example, if lottery a A b b The first and second patients are in the first group and the third and fourth patients are in the second group and also for the next four patients, a card is issued again. The anesthesia and injection stage will be performed by an anesthesiologist and The questionnaire is reviewed and completed by an anesthesiologist in the operating room and recovery.
Describe how to blind
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is conducted in a double-blind manner, that is, patients, doctors, caregivers, and statistical analysts will not know about the allocation of groups to reduce bias. In these studies, random assignment is used to allocate patients into two groups: the experimental group and the control group. Researchers and participants are made aware of who is in which group.
The study will be conducted in a way that the surgeon, nurses, patients, and the data analyst will not know the type of painkillers injected into the control and intervention groups. Statistical analyst will be selected from outside the treatment team to ensure double-blindness of the study to a large extent. When the patient is not aware of the type of medicine received, the effect of the patient's personal characteristics and psychological aspect on the research results is reduced. Researchers are unaware of which type of painkillers the participant receives. Therefore, the impact of the doctor's judgments in evaluating the clinical symptoms and the patient's pain after surgery is minimized. By using this method, we try to reduce the effect of possible biases in the results (the effect of methadone and morphine in reducing pain).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qom University of Medical Sciences
Street address
Alley 1, Safashahr St.
City
Qom
Province
Ghoum
Postal code
3714816335
Approval date
2022-05-12, 1401/02/22
Ethics committee reference number
IR.MUQ.REC.1401.012
Health conditions studied
1
Description of health condition studied
Comparison of the effect of methadone and morphine on pain after rhinoseptoplasty surgery
ICD-10 code
R52
ICD-10 code description
Acute Pain
Primary outcomes
1
Description
Pain after surgery
Timepoint
The study compares the effect of methadone and morphine on pain after rhinoseptoplasty surgery to measure pain half an hour after surgery and at the end of surgery , patient extubation and recovery 1 and 6 hours after surgery.
Method of measurement
In the study "Comparative study of the effect of methadone and morphine on pain after rhinoseptoplasty surgery" is the method of measuring the outcome variable using a clinical information checklist and the second part is the use of a standard pain intensity questionnaire (Visual Analogue Scale) to determine pain intensity in patients. The Visual Analogue Scale (VAS) is a subjective measure of pain. It consists of a 10cm line with two endpoints representing ‘no pain’ and ‘worst pain imaginable’. Patients are asked to rate their pain by placing a mark on the line corresponding to their current level of pain. The distance along the line from the ‘no pain’ marker is then measured with a ruler giving a pain score out of 10.
2
Description
Hemodynamic variables. (blood pressure, Saturation of Peripheral Oxygen)
Timepoint
The study compares the effect of methadone and morphine on pain after rhinoseptoplasty surgery to measure Hemodynamic variables half an hour after surgery and at the end of surgery , patient extubation and recovery 1 and 6 hours after surgery.
Method of measurement
Mercury sphygmomanometer.( for the measurement of blood pressure ).Pulse Oximeter (for the measurement of Saturation of Peripheral Oxygen)
3
Description
Saturation of Peripheral Oxygen
Timepoint
The study compares the effect of methadone and morphine on pain after rhinoseptoplasty surgery to measure (Saturation of Peripheral Oxygen )half an hour after surgery and at the end of surgery , patient extubation and recovery 1 and 6 hours after surgery.
Method of measurement
Pulse Oximeter
4
Description
blood pressure
Timepoint
The study compares the effect of methadone and morphine on pain after rhinoseptoplasty surgery to measure (blood pressure ) half an hour after surgery and at the end of surgery , patient extubation and recovery 1 and 6 hours after surgery.
Method of measurement
Mercury sphygmomanometer
Secondary outcomes
1
Description
In the study "Comparative study of the effect of methadone and morphine on pain after rhinoseptoplasty" the secondary outcome could be "hemodynamic changes".
Timepoint
The patient hemodynamics are recorded at the end of the operation, patient extubation and recovery and 1 and 6 hours after surgery.
Method of measurement
In this study, using the patient's personal and clinical information checklist, including blood pressure and heart rate and blood oxygen saturation.
Intervention groups
1
Description
Intervention group: n the main and studied group, the desired dose of the drug is 0.15 mg per body weight (ideal weight). Methadone is administered slowly intravenously half an hour after the start of surgery.
Category
Treatment - Drugs
2
Description
Control group: In this group, the desired dose of the drug is 0.15 mg per body weight (ideal weight). Morphine is administered slowly intravenously half an hour after the start of surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Forghani Hospital
Full name of responsible person
Dr. Vahid Daman Pak Moghadam
Street address
Azar St., next to the gas station, Forghani Hospital
City
QOM
Province
Ghoum
Postal code
3714816335
Phone
+98 25 3721 1301
Email
educationmo110@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Qom
Full name of responsible person
Dr. Hamid Daman Pak Moghadam
Street address
Forghani Hospital,after the gas station, Azar St.
City
Qom
Province
Ghoum
Postal code
3714816335
Phone
+98 25 3721 1301
Email
Educationmo110@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Qom
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
2
Sponsor
Name of organization / entity
Qom Medical Sciences Research Deputy
Full name of responsible person
Dr. Alireza Kuhpaei
Street address
Alley4,Alley One, Safashahr street
City
Qom
Province
Ghoum
Postal code
3714816335
Phone
+98 912 252 1634
Email
Educationmo110@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qom Medical Sciences Research Deputy
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
The University of Qom
Full name of responsible person
Vahid Daman Pak Moghaddam
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Forghani Hospital, after the gas station,Azar St
City
Qom
Province
Ghoum
Postal code
3714816335
Phone
+98 25 3711 8334
Email
educationmo110@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Qom
Full name of responsible person
Vahid Daman Pak Moghaddam
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Forghani Hospital,after the gas station,Azar St.
City
Qom
Province
Ghoum
Postal code
3714816335
Phone
+98 25 3721 1301
Email
educationmo110@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Qom
Full name of responsible person
Vahid Daman Pak Moghaddam
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Forghani Hospital, After the gas station,Azar street
City
Qom
Province
Ghoum
Postal code
3714816335
Phone
+98 25 3721 1301
Email
educationmo110@gmail.com
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
It can be published as much as possible
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Results only
From where data/document is obtainable
Dr. Daman Pak Forqani Hospital
What processes are involved for a request to access data/document