Determining the effect of morphine and oxycodone on pain in patients with limb fractures
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 92 patients. Block randomization method was used for randomization and block randomization sequence was generated by online software.
Settings and conduct
Valiasr Hospital,Arak,1399. only the in charge specialist of the study is aware of the type of study and study groups, while patients are not aware of the type of prescription drug. Also, the intern only recognizes the groups based on A and B and fills out checklists accordingly. In the first group, 46 patients receive injectable morphine and placebo, and in the second group, 46 patients receive oral oxycodone and injectable placebo. Receipt of medication will be done immediately after transferring the patient to the ward. Patients will then be evaluated for pain intensity based on the VAS ruler before ,30 min,2 and 6 hr after drug administration and pain intensity will be compared. Patients with a VAS score higher than 5 will be excluded from the study..
Participants/Inclusion and exclusion criteria
213/5000
All patients with lower limb fractures (tibia and femur) who are candidates for analgesia after surgery
No opioid addiction
No history of diabetes and kidney failure
No drop in blood pressure, bradycardia and decreased respiratory level
Intervention groups
92 patients are divided into two groups. In the first group, 46 patients received injectable morphine and placebo, and in the second group, 46 patients received oral oxycodone and injectable placebo. Receiving the drug after surgery and after transferring the patient to the ward by the responsible intern will be based on the drugs of groups A and B (previously prepared by the main executor of the project) and without mentioning the name of the drug.
Main outcome variables
pain Intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200708048062N1
Registration date:2020-08-10, 1399/05/20
Registration timing:prospective
Last update:2020-08-10, 1399/05/20
Update count:0
Registration date
2020-08-10, 1399/05/20
Registrant information
Name
Pouria Rezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3278 4849
Email address
pouriare7@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-15, 1399/05/25
Expected recruitment end date
2020-09-05, 1399/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of morphine and oxycodone on pain in patients with limb fractures
Public title
The effect of oxycodone on limb fracture pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients whose bone fractures of the lower extremity (tibia and femur) are confirmed by graphic and are candidates for analgesia after surgical treatment.
Age between 18 to 60 years
Exclusion criteria:
opioid addiction
hypotension, bradycardia, or decreased respiratory rate.
history of diabetes and kidney failure.
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 92 patients were divided into two completely equal groups using morphine and oxycodone using block randomization method. Block randomization method with quadratic block size was used to divide patients into two groups. In this way, using online software (sealedenvelope), the randomization sequence was generated in a block method and remained with the epidemiologist. Following patient diagnosis and based on the generated randomization sequence, a decision was made to assign individuals to groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to the two-sided blindness of the study, in this study, only the relevant specialist in charge of the study (Dr. Solhi, Dr. Azami) is aware of the type of study and the study groups, while patients are of the prescribed drug type. They are not aware. Also, the intern in charge of the project who is in charge of filling out the checklists is not aware of the type of groups based on the prescription drug and only recognizes the groups based on A and B and fills out the checklists accordingly. In the first group, 46 patients receive injectable morphine and placebo, and in the second group, 46 patients receive oral oxycodone and injectable placebo. Receiving the drug after surgery and immediately after transferring the patient to the ward by the responsible intern will be based on group A and B drugs (previously prepared by the main executor of the project) and without mentioning the name of the drug.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Payambar-e-azam Complex, Basij Sq., Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2020-07-12, 1399/04/22
Ethics committee reference number
IR.ARAKMU.REC.1399.144
Health conditions studied
1
Description of health condition studied
Tibial fracture
ICD-10 code
S82.1
ICD-10 code description
Fracture of upper end of tibia
2
Description of health condition studied
Tibial fracture
ICD-10 code
S82.2
ICD-10 code description
Fracture of shaft of tibia
3
Description of health condition studied
Tibial fracture
ICD-10 code
S82.3
ICD-10 code description
Fracture of lower end of tibia
4
Description of health condition studied
Femoral bone fracture
ICD-10 code
S72
ICD-10 code description
Fracture of femur
Primary outcomes
1
Description
Intensity of pain
Timepoint
Before the intervention and 30 minutes, 2 hours and 6 hours after the intervention
Method of measurement
Visual Analogue Scale of Pain
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: 46 patients with lower limb fractures (femur and tibia) immediately after surgery and transferred to the inpatient department of morphine sulfate 5 mg intravenously and 2 oral placebo tablets at the same time to control pain Patients with a VAS score above 5 will be treated according to the standard protocol and excluded from the study, and their number will be recorded in the study. Patients were also evaluated for blood pressure and respiratory level and in case of hypotension, bradycardia, decreased respiratory level and bone fractures will be excluded from the study and their number will be recorded in the study.
Category
Treatment - Drugs
2
Description
Intervention group2: 46 patients with lower limb fractures (femur and tibia) Immediately after surgery and transfer to the hospital ward once, 2 oxycodone 5 mg tablets simultaneously and orally and intravenously injectable placebo to control pain Patients with a VAS score above 5 will be treated according to the standard protocol and excluded from the study, and their number will be recorded in the study. Patients were also evaluated for blood pressure and respiratory level and in case of hypotension, bradycardia, decreased respiratory level and bone fractures will be excluded from the study and their number will be recorded in the study.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Pouria Rezae
Street address
Valiasr Sq.
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
pr_valieasr@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Payambar-e-azam Complex, Basij Sq., Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Pouria Rezae
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Payambar-e-azam Complex, Basij Sq., Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Pouria Rezae
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Payambar-e-azam Complex, Basij Sq., Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Pouria Rezae
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Payambar-e-azam Complex, Basij Sq., Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available