Objective: Comparison the analgesic and side effect of morphine and intravenous ketamine in patient with musculoskeletal injury.
Inclusion criteria:
patients in the age range of 18-70 Years, Severe acute musculoskeletal pain between 6-10 VAS
Exclusion criteria included :
patient refusal
addiction
SBP<90
GCS<90
presence of cardiac, pulmonary , renal, psychiatric disease
Pregnancy or breast feeding
allergy to ketamine or morphine,
require to CNC block
inability to underestand vas concepts
The subjects consisted of patients with musculoskeletal trauma injury, referring to the emergency unit. According to statistical analyzez 300 patients are enroled the study.
methods:
patients are randomly divide into two groups. The group receiving morphine at a dose of 0.1 mg/kg and 3mg/kg are used for every 5 minute and the group receiving IV ketamine at a dose of 0.2 mg/kg. Finally, obtain information (decreasing pain severity and side effect) are evaluated and recorded after 0,30 and 60 second.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015111024979N1
Registration date:2015-12-15, 1394/09/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-15, 1394/09/24
Registrant information
Name
Maryam Fattahi
Name of organization / entity
Iran University of Medical Sciences, Medicen Department
Country
Iran (Islamic Republic of)
Phone
+98 86701
Email address
rfateh@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Iran University of Medical Sciences
Expected recruitment start date
2014-06-05, 1393/03/15
Expected recruitment end date
2015-11-22, 1394/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the analgesic and side effect of morphine with low dose intravenous ketamine in patient with musculoskeletal trauma injury
Public title
Comparison efficacy of morphine with low dose intravenous ketamine in patient with musculoskeletal trauma injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients in the age range of 18-70 Years, Severe acute musculoskeletal pain between 6-10 VAS
Exclusion criteria included :
patient refusal
addiction
SBP<90
GCS<90
presence of cardiac, pulmonary , renal, psychiatric disease
Pregnancy or breast feeding
allergy to ketamine or morphine,
require to CNC block
inability to underestand the vas concepts
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Shahid Hemmat freeway, next to Milad tower
City
Tehran
Postal code
1449614535
Approval date
2014-07-06, 1393/04/15
Ethics committee reference number
IR.IUMS,REC.1394.9211307021
Health conditions studied
1
Description of health condition studied
Patients with musculoskeletal truma injury
ICD-10 code
M95-M99
ICD-10 code description
Other disorders of the musculoskeletal system and connective tissue
Primary outcomes
1
Description
Decreasing pain severity
Timepoint
0,30,60 minute after intervention
Method of measurement
Visual Analog Scale
Secondary outcomes
1
Description
Itchy
Timepoint
0,30 60 minet after injection
Method of measurement
Researcher observation or patient discribe
Intervention groups
1
Description
First intervention group: The group receiving IV morphine at a dose of 0.1
mg/kg of body weight
Category
Treatment - Drugs
2
Description
Second intervention:The group receiving IV ketamine at a dose of
0.2 mg/kg of body weight
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Eemergency Unit of Iran University Hospitals
Full name of responsible person
Maryam Fattahi
Street address
Iran University of Medical Sciences
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Iran University of Medical Sciences
Full name of responsible person
Dr Mossavi
Street address
Shahid Hemmat freeway, next to Milad tower
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of 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
Maryam Fattahi
Position
Emergency Resident
Other areas of specialty/work
Street address
Shahid Hemmat freeway, next to Milad tower
City
Tehran
Postal code
Phone
+98 21 86701
Fax
Email
fattahiazam63@gmail.com; rfateh@muq.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Fattahi
Position
Emergency Medicine Resident
Other areas of specialty/work
Street address
Shahid Hemmat freeway, next to Milad tower
City
Tehran
Postal code
Phone
+98 21 86701
Fax
Email
fattahiazam63@gmail.com; rfateh@muq.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Fattahi
Position
Emergency Medicine Resident
Other areas of specialty/work
Street address
Shahid Hemmat freeway, next to Milad tower
City
Tehran
Postal code
Phone
00
Fax
Email
fattahiazam63@gmail.com; rfateh@muq.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)