The effect of morphine with oxycodone in relieving pain in patients is compared with pain due to bone metastases
Design
Randomized clinical trial, with parallel groups, double-blind, phase 3 on 32 patients, block method and online software www.sealedenvelope.com were used for randomization.
Settings and conduct
This study is a double-blind randomized clinical trial in Khansari Hospital in Arak in 1399 with easy sampling. All patients who are candidates for analgesia and have inclusion criteria will be evaluated as the study population after completing the informed consent form. In this study, 32 patients are divided into two completely equal groups using morphine and oxycodone using block randomization. Due to the two-sided blindness of the study, in this study, only specialists The person in charge of the study is aware of the type of study and the study groups, while patients are not aware of the type of prescription drug. It is not aware and only recognizes groups based on A and B and fills checklists accordingly.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with malignancy with bone metastasis confirmed by bone scan Candidate for analgesia, vas less than 6. Exclusion criteria: history of diabetes and kidney failure, bone fracture, hypotension, bradypnea
Intervention groups
In the first intervention group, 16 patients received 5 mg morphine intravenously and placebo tablets only once at the beginning of the intervention and in the second intervention group, 16 patients took two 5 mg oxycodone tablets orally, together and by injection alone. Once received at the beginning of the intervention.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201202049575N1
Registration date:2020-12-09, 1399/09/19
Registration timing:prospective
Last update:2020-12-09, 1399/09/19
Update count:0
Registration date
2020-12-09, 1399/09/19
Registrant information
Name
Mahdi Farahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3505
Email address
m.mahdi.f.13732324@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of morphine and oxycodone in relieving pain in patients with bone metastasis pain
Public title
The effect of morphine and oxycodone on bone metastatic pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with malignancy whose bone metastasis has been confirmed by bone scan and are candidates for analgesia.
Pain intensity less than 6 based on vas ruler
Exclusion criteria:
Have low blood pressure, Bradypnea
Have a bone fractures
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:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Using block randomization method and online statistical software (www.sealedenvelope.com), 32 patients will be divided into two equal groups of intervention and control in 8 blocks of 4. To hide random sequences, the sealed envelope method is used. First, a random sequence is created by one of the mentioned methods. , Are prepared and each of the random sequences created is recorded on a card and the cards are placed in the envelopes in order. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, according to the order of entry of eligible participants into the study, one of the envelopes is opened in order and the assigned group of the participant is revealed.
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to the double-blindness of the study, blindness is such that only the relevant specialist in charge is aware of the type of the study and groups , while patients are not aware of the type of prescription drug and blind using injectable and oral placebo. Also, the clinical caregivers and interns in charge of the project, who are in charge of filling out the checklists, are not aware of the type of groups based on the prescription drug and only recognize the groups based on A and B and check the checklists.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
thics committee of Arak University of Medical Sciences
Street address
Payambar-e-azam Complex, Basij Sq., Sardasht
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2020-11-08, 1399/08/18
Ethics committee reference number
IR.ARAKMU.REC.1399.230
Health conditions studied
1
Description of health condition studied
Bone metastasis
ICD-10 code
C41
ICD-10 code description
Malignant neoplasm of bone and articular cartilage of other and unspecified sites
Primary outcomes
1
Description
Pain
Timepoint
Before the intervention, 30 minutes, 2 hours and 6 hours after the intervention
Method of measurement
visual analogue scale for pain
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: In the first group, 16 patients received morphine sulfate (Darupakhsh-Iran) 5 mg intravenously once at the beginning of the intervention and two placebo tablets orally once at the beginning of the intervention.
Category
Treatment - Drugs
2
Description
Second intervention group: In the second group, 16 patients receive two 5 mg oxycodone tablets (Shafa-Iran) orally and simultaneously, and only once at the beginning of the intervention and an injectable placebo of 5 ml, once at the beginning of the intervention.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Mahdi Farahani
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
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
Mahdi Farahani
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Payambar-e-azam Complex, Basij Sq., Sardasht
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
Mahdi Farahani
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Payambar-e-azam Complex, Basij Sq., Sardasht
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3645
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
Mahdi Farahani
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Payambar-e-azam Complex, Basij Sq., Sardasht
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3645
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