Objectives: To compare the effect of two methods of controlling and non-controlling pain in extremity trauma patients admitted to the emergency room triage. Design: Randomized, single-blind, single-center, phase II clinical trial. Performance: pain will be controlled in one group and will not controlled in the other. Inclusion criteria included patients with extremity trauma. Exclusion Criteria included patients who have stomach ulcers and Mental diseases. Interventions: In the first intervention group the pain is controlled and in the second intervention group the pain is not controlled. The main outcome: Rate of patients' satisfaction.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017020227457N3
Registration date:2017-02-20, 1395/12/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-20, 1395/12/02
Registrant information
Name
Mehdi Rezaie
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2107
Email address
rezaei.me@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of pain controlon patients’ satisfaction in patients with extremities trauma
Public title
Survey the effect of pain control in patients with extremities trauma in triage room on the outcome and patients’ satisfaction
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria included patients with extremity trauma. Exclusion Criteria
included patients who have stomach ulcers and Mental diseases.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not 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
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Approval date
2016-09-22, 1395/07/01
Ethics committee reference number
IR.iums.Rec1395.9311307013
Health conditions studied
1
Description of health condition studied
extremities trauma
ICD-10 code
M 12.5
ICD-10 code description
Transient arthropathy
Primary outcomes
1
Description
Patient satisfaction of extremity trauma
Timepoint
After controlling pain
Method of measurement
Based on feedback from patients
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: control pain in triage room. Patients in the intervention group receive 0.05 mg/kg morphine sulfate.
Category
Treatment - Drugs
2
Description
Control group: Without control pain in triage room. Patients in control group received distilled water.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Firuzgar Hospital
Full name of responsible person
Dr Mehdi Rezaie
Street address
Beh afarin Ave, Firuzgar Hospital.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Dr Morteza Naserbakht
Street address
Fifth floor, Central staff, Iran University of Medical Sciences, 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 chancellor for research, 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
Dr Mehdi Rezaie
Position
Emergency Medicine Specialist
Other areas of specialty/work
Street address
Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Phone
+98 216435210
Fax
Email
rezaei.me@iums.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
Dr Mehdi Rezaie
Position
PhD
Other areas of specialty/work
Street address
Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Phone
+98 21 8670 2503
Fax
Email
rezaei.me@iums.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
Dr Mehdi Rezaie
Position
Emergency Medicine Specialist
Other areas of specialty/work
Street address
Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Phone
+98 21 8670 2503
Fax
Email
rezaei.me@iums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)