Evaluate and compare the analgesic effect of morphine combined with different low dose of ketamine , as compared to morphine in trauma patients admitted to the emergency department with acute , moderate to severe pain.
In this randomized clinical trial, the purpuse is to compare the effect of adding different doses of ketamin to the morphin for analgesia. patients with extremity trauma over 18 years old whom admitted in emergency department for a limb trauma and has moderate and severe pain will be considered.
they will be divided into three groups. After injection of 0.1mg / kg of morphine ,low dose of will be add to patients (0.15mg / kg and 0.3mg / kg) in the two groups and several mL of saline as placebo is administered in the third group.
Pain on the Visual Analog Scale for Pain-VAS scoring system before and after administration of morphine and ketamine is calculated at regular intervals up to 3 hours. And chart notes will be relevant. Pain relief will be examined and possible complications in three groups. Finally, the effect of ketamine on morphine for pain relief and reduce complications associated with use of this drug will be compared between the three groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016030626927N1
Registration date:2016-06-09, 1395/03/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-09, 1395/03/20
Registrant information
Name
Mohammad Baghaei
Name of organization / entity
Iran university
Country
Iran (Islamic Republic of)
Phone
+98 21 8899 5017
Email address
dr.baghaei.m@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice President of Research IN Iran University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-04-18, 1395/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluate and compare the analgesic effect of morphine combined with different low dose of ketamine , as compared to morphine in trauma patients admitted to the emergency department with acute , moderate to severe pain.
Public title
Evaluate and compare the analgesic effect of morphine combined with different low dose of ketamine , as compared to morphine in trauma patients admitted to the emergency department with acute , moderate to severe pain.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
LIMB TRAUMA;PAIN SCORE>5 ;AGE between 18-65 ; no Underlying disease ; No history of drug allergy ; No history of addiction;
Exclusion criteria:
Lack of coperation or consent of the patient during the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences, Research Ethics Committee
Street address
hemmat highway beside the Milad tower Iran University of Medical Sciences
City
tehran
Postal code
Approval date
2015-12-08, 1394/09/17
Ethics committee reference number
ir.iums.rec.1394.9211307032
Health conditions studied
1
Description of health condition studied
UPPER limb injury
ICD-10 code
T10
ICD-10 code description
Fracture of upper limb, level unspecified
2
Description of health condition studied
injuries of upper limb, level unspecified
ICD-10 code
t11
ICD-10 code description
Other injuries of upper limb, level unspecified
3
Description of health condition studied
Other injuries of lower limb, level unspecified
ICD-10 code
t13
ICD-10 code description
Other injuries of lower limb, level unspecified
4
Description of health condition studied
Fracture of lower limb, level unspecified
ICD-10 code
T12
ICD-10 code description
Fracture of lower limb, level unspecified
Primary outcomes
1
Description
pulse rate
Timepoint
At the indicated times after injection: minutes 0 15 30 60 90 120 150 180
Method of measurement
counting
2
Description
respiratory rate
Timepoint
At the indicated times after injection: minutes 0 15 30 60 90 120 150 180
Method of measurement
counting
3
Description
pain
Timepoint
At the indicated times after injection: minutes 0 15 30 60 90 120 150 180
Method of measurement
vissual scale assessment
4
Description
blood pressure
Timepoint
At the indicated times after injection: minutes 0 15 30 60 90 120 150 180
Method of measurement
manometer
5
Description
o2 saturation
Timepoint
At the indicated times after injection: minutes 0 15 30 60 90 120 150 180
Method of measurement
pulse oxymetry
Secondary outcomes
1
Description
nausea
Timepoint
To 3 hours after injection.
Method of measurement
patient warning
2
Description
vomitting
Timepoint
To 3 hours after injection.
Method of measurement
patient warning
3
Description
apnea
Timepoint
To 3 hours after injection.
Method of measurement
patient warning
4
Description
hypoventiation
Timepoint
To 3 hours after injection.
Method of measurement
patient warning
5
Description
aspiration
Timepoint
To 3 hours after injection.
Method of measurement
patient warning
6
Description
confusion
Timepoint
To 3 hours after injection.
Method of measurement
patient warning
7
Description
dysphpria
Timepoint
To 3 hours after injection.
Method of measurement
patient warning
8
Description
drug reaction
Timepoint
To 3 hours after injection.
Method of measurement
patient warning
Intervention groups
1
Description
Injection of 0.1mg / kg of morphine with a few ml of distilled water in separate syringes in the control group
Category
Treatment - Drugs
2
Description
Injection of 0.1mg / kg morphine with low doses of ketamine in the intervention group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye hafte tir hospital
Full name of responsible person
Mohammad Baghaei
Street address
Rajai highway
City
Tehran
2
Recruitment center
Name of recruitment center
Firuzgar hosptal
Full name of responsible person
Mohammad Baghaei
Street address
Firooz alley Valiasr square
City
Tehran
3
Recruitment center
Name of recruitment center
Rasool Akram hospital
Full name of responsible person
Mohammad Baghaei
Street address
Sattarkhan street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice President of Research IN Iran University of Medical Sciences
Full name of responsible person
Mrs Irani
Street address
Hemmat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice President of Research IN Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Baghaei
Position
resident
Other areas of specialty/work
Street address
Sattarkhan street Rasool Akram hospital
City
Tehran
Postal code
Phone
+98 21 8899 5017
Fax
Email
dr.baghaei.m@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Saeed Abbasy
Position
Emergency Medicine Specialist
Other areas of specialty/work
Street address
Sattarkhan street Rasool Akram hospital
City
tehran
Postal code
Phone
+98 21 8899 5017
Fax
+98 21 5521 7901
Email
saieedabbasi@yahoo.com
Web page address
http://hospht.iums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Baghaei
Position
resident
Other areas of specialty/work
Street address
Sattarkhan street Rasool Akram hospital
City
Tehran
Postal code
Phone
+98 21 8899 5017
Fax
Email
dr.baghaei.m@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)