After approval the study at Kermanshah University of Medical Sciences, it started at Taleghani Hospital Emergency Department. This study was designed as a double blind clinical trial to compare the effect of Ketamine with Morphine in controlling pain in patients with limb fracture. Patients were randomly divided into two groups based on case profile number.
The patients and the analyst were blinded to the two groups and prescribed drugs. In this way, the analyst received the information in two groups of A and B . The patients were not informed what drugs were prescribed and the injection was intravenous in both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria consist of
The patient with trauma to limbs,
The patient aged of 18 to 80 years old.
Exclusion criteria consist of:
Decreased level of consciousness.
Addiction to opium,
Unstable vital sign
Intervention groups
Patients were divided into two intervention groups 1 and 2. The intervention group 1 was treated with morphine produced by the Iranian Daroopakhsh Company in a dose of 0.1 mg /kg body weight as intravenously in one dose, and the intervention group 2 was treated with Ketamine produced by Rotex Med, Germany Company in a dose of 0.3 mg /kg body weight as intravenously in one dose.
Main outcome variables
pain score base of visual analog score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180108038276N2
Registration date:2019-06-17, 1398/03/27
Registration timing:registered_while_recruiting
Last update:2019-06-17, 1398/03/27
Update count:0
Registration date
2019-06-17, 1398/03/27
Registrant information
Name
amir noyani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3336 2186
Email address
a.noyani@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-07-01, 1398/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Ketamine with Morphine in control of pain in patients with limb fracture referring to the hospital
Public title
Ketamine and Morphine role in control of pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patient with limbs trauma
patients with aged of 18 to 80 years old
Exclusion criteria:
The patient with decreased level of consciousness
The patient with unstable vital sign
Addiction to opium
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
120 Patients entered into the study were divided into two groups of Morphine and Ketamine recipient. They divided in two groups according the file number. Even number in Ketmine group and odd number in Morphine group were placed.The analyst received data as the group A and group B.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients and the analyst were blinded to the two groups and prescribed drugs. In this way, the analyst received the information in two groups of A and B . The patients were not informed what drugs were prescribed and the injection was intravenous in both groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Kermanshah University of Medical Science
Street address
Kermanshah University of Medical Sciences, Shahid Beheshti Blvd.Kermashah,iran
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2019-04-30, 1398/02/10
Ethics committee reference number
IR.KUMS.REC.1398.096
Health conditions studied
1
Description of health condition studied
Traumatic Patients
ICD-10 code
G89.11
ICD-10 code description
Acute pain due to trauma
Primary outcomes
1
Description
Pain Score of limbs fracture Patients according to Visual Analog Scale
Timepoint
before intervention and 5,10,30 min after administration of drug
Method of measurement
Visual Analog Scale
Secondary outcomes
1
Description
Pain Relief
Timepoint
before intervention and in 5-10-30 minutes after intervention
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Intervention group 1 was treated with morphine produced by the Iranian Daroopakhsh Company in a dose of 0.1 mg /kg body weight intravenously in one dose.
Category
Treatment - Drugs
2
Description
Intervention group 2 was treated with Ketamine produced by Rotex Med, ,Germany Company in a dose of 0.3 mg /kg body weight intravenously in one dose.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hosptall Kermanshah
Full name of responsible person
Amir Noyani
Street address
Taleghani hospital,Taleghani Street,Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
+98 23 3223 8115
Email
A.NOYANI@SHMU.AC.IR
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Kermanshah university of Medical Science, Taleghani Street, Kermanshah,Iran
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
+98 83 3837 0541
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Amir Noyani
Position
Assistance professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Taleghani hospital,Taleghani Street, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
+98 23 3223 8115
Email
A.NOYANI@SHMU.AC.IR
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Amir Noyani
Position
Assistance Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Taleghani hospital, Taleghani Street, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
+98 23 3223 8115
Email
A.NOYANI@SHMU.AC.IR
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Amir Noyani
Position
Assistance professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Taleghani hospital, taleghani street, kermanshah city
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
+98 23 3222 1620
Email
a.noyani@shmu.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
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
Data on demographic information and patient pain are distributed as anonymous codes
When the data will become available and for how long
Starting data access is from 2019 .
To whom data/document is available
Access to data will be free for anyone interested in research
Under which criteria data/document could be used
Granting data for scientific use without fringe is allowed
From where data/document is obtainable
Can contact with a.noyani@shmu.ac.ir email
What processes are involved for a request to access data/document
About a month from the time of the first call through the email