Comparison of the effect ofmorphine and oxycodone onacute renal colic
Design
This double-blind and clinical trial .54 patients with renal colic at Valiasr Hospital in Arak. We will divide patients in 2 groups by simple randomization. Groups are parallel.
Settings and conduct
This double-blind and clinical trial .54 patients with renal colic at Valiasr Hospital in Arak. We will divide patients in 2 groups by simple randomization with envelopes.The study is double-blind.Outcome elevator and analyzer and participant are blind (double blind).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18 to 60, no drug addiction, pain caused by renal colic, people who have less than 8 pain criteria, not receiving housing in the last 6 hours, people whose pain does not decrease after 2 hours
Exclusion criteria:Vomiting after taking oral painkillers, conscious dissatisfaction
Intervention groups
In the placebo group, 27 patients receive morphine in the amount of 5 milligram of oral placebo and in the second group, 27 patients received 10 milligram of oxycodone and injectable placebo.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200702047986N1
Registration date:2020-09-05, 1399/06/15
Registration timing:registered_while_recruiting
Last update:2020-09-05, 1399/06/15
Update count:0
Registration date
2020-09-05, 1399/06/15
Registrant information
Name
Davoud Shabani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3367 3149
Email address
davoud9372@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2021-06-22, 1400/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect ofmorphine and oxycodone onacute renal colic
Public title
Comparison of the effect ofmorphine and oxycodone onacute renal colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 60
No drug addiction
Pain caused by renal colic
People who have less than 8 pain criteria
Not receiving housing in the last 6 hours
People whose pain does not decrease after 2 hours
Exclusion criteria:
Vomiting after taking oral painkillers
Conscious dissatisfaction
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with randomization with envelopes in 2 groups A and B.
In this method, we selected a number of cards or letters as an intervention group and the same number of cards for the control group, then the cards were merged. One card was taken out and its allocation was registered and the card was returned to the other cards after leaving. Then the cards are merged again and we remove another card. This process continues to reach a random sequence according to sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is clinical trial.Outcome elevator and analyzer and participant are blind (double blind).Outcome elevator and analyzer and participant don't aware from group.
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
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2020-06-14, 1399/03/25
Ethics committee reference number
IR.ARAKMU.REC.1399.096
Health conditions studied
1
Description of health condition studied
Renal colic
ICD-10 code
N23
ICD-10 code description
Unspecified renal colic
Primary outcomes
1
Description
Pain
Timepoint
At zero hours (before prescribing the drug) and 30 minutes and two hours after receiving the drug
Method of measurement
Visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Twenty-seven patients received 10 mg of oxycodone from the University Narcotics Office in the form of two 5 mg oral tablets at the same time and an intravenous injection placebo only once at the time of admission.
Category
Treatment - Drugs
2
Description
Control group: In the second group, 27 patients received injectable morphine sulfate from the University Narcotics Office, 5 mg intravenously as a single placebo and placebo oral tablets only once at the beginning of hospitalization.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Mohammad Jamalian
Street address
Valiasr hospital, Valiasr squre
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
m.jamalian@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
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
Dr Mohammad Jamalian
Position
Assistant
Latest degree
Specialist
Other areas of specialty/work
Forensic Medicine
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
m.jamalian@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Jamalian
Position
Assistant
Latest degree
Specialist
Other areas of specialty/work
Forensic Medicine
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street