Comparison of analgesic effects of intravenous morphine sulfate and intranasal dexmedetomidine with alone intravenous morphine sulfate in opoids consumer patients with extremity fractures presented in emergency departments of Shohadaye 7-Tir ،hezrate rasool & firoozgar hospitals
The purpose of the study is to compare the effect of intravenous morphine with nasal dexmedetomidine and morphine on pain intensity and morphine intake in drug abuse patients with extremity fracture referring Emergency
Design
The study design is a randomized clinical trial. The randomization method is block type. The sample size for each study group is 30 persons.
Settings and conduct
In this study, all patients referred to the Emergency Department of Haft-e-Tir , Hazrat Rasool and Firoozgar Hospital, who have extremity fractures, will be enrolled in the study. Patients will be randomly divided into two groups based on 10 blocks. A total of 60 patients will be evaluated. Patients and information analysts will be blind.
Participants/Inclusion and exclusion criteria
All patients referred to the Emergency Department of Haft-e-Tir , Hazrat Rasool and Firoozgar Hospital with extremity fractures will be enrolled.
Inclusion criteria: Limb trauma leading to acute fractures, patients over 18 years.
Exclusion criteria: Decreased consciousness, chronic renal and cardiovascular disease, pregnancy, alcohol use and psychotropic drugs.
Intervention groups
In the intervention group, patients received 5 mg morphine plus
Dexmedetomidine is one tenth of a milligram per kilogram of body weight
Will receive. In control group, patients received 5 mg morphine plus nasal placebo which will be distilled water.
Main outcome variables
Severity of pain after administration, total dose
General information
Reason for update
Acronym
Iran Ems Study
IRCT registration information
IRCT registration number:IRCT20190608043839N1
Registration date:2020-05-26, 1399/03/06
Registration timing:prospective
Last update:2020-05-26, 1399/03/06
Update count:0
Registration date
2020-05-26, 1399/03/06
Registrant information
Name
Ahmad Vafajoo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4244 1527
Email address
dr.vafajoo@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-10-22, 1399/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of analgesic effects of intravenous morphine sulfate and intranasal dexmedetomidine with alone intravenous morphine sulfate in opoids consumer patients with extremity fractures presented in emergency departments of Shohadaye 7-Tir ،hezrate rasool & firoozgar hospitals
Public title
Effects of intravenous morphine sulfate and intranasal dexmedetomidine in extremity fractures patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Opoids consumer
Acute extremity fracture
Age Above 18 years old
Exclusion criteria:
Low of consciousnesses
Chronic renal failure
Cirrhosis
Pregnancy
Alcohol use
Heart & vascular disease
Psychotropic drugs use
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into two groups. in order to
Randomization The block randomization method will be used.
For this purpose 10 blocks will be formed and 5 blocks per block
In the intervention group and 5 people in the control group. Overall
6 blocks will be considered to reach the sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
The information will be analyzed by a person who does not know the study groups. Patients will be unaware of the treatment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Medical School Research - Iran University of Medical Sciences
Street address
Block A, 13th Floor, Iran Sime St. - Headquarters of Ministry of Health and Medical Education, Between South Flamak and Zarafshan, Qods Town (West)
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2019-09-24, 1398/07/02
Ethics committee reference number
IR.IUMS.FMD.REC.1398.300
Health conditions studied
1
Description of health condition studied
Extremity fractures
ICD-10 code
M84.4
ICD-10 code description
Pathological fracture, not elsewhere classified
Primary outcomes
1
Description
Severity of pain after drug administration
Timepoint
After 15, 30, 60 and 120 minutes after drug administration
Method of measurement
Visual Numerical Rating Scale
Secondary outcomes
1
Description
Total dosage of the drug
Timepoint
After the end of treatment
Method of measurement
Based on the information in the patient file
Intervention groups
1
Description
Intervention group: Patients will receive morphine at a dose of 5 mg plus dexmedetomidine 1.5 mg / kg.
Category
Treatment - Drugs
2
Description
Control group: Patients will receive morphine at a dose of5 mg plus a nasal placebo that will be distilled water.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Rasool Akram Hospital
Full name of responsible person
Ahmad Vafajoo
Street address
Emergency Department of Hazrat Rasoul Hospital Complex, Niayesh Ave., Sattarkhan, Iran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2190
Fax
+98 21 6435 2190
Email
ir.ac.iums@hrmc
Web page address
http://hrmc.iums.ac.ir/
2
Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
َAhamd Vafajoo
Street address
Street to Afar, Vali Asr Square
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1600
Fax
+98 21 8214 1600
Email
com.yahoo@firoozgar_h
Web page address
http://firoozgar.iums.ac.ir/
3
Recruitment center
Name of recruitment center
7th Tir Martyrs Hospital
Full name of responsible person
Ahmad Vafajoo
Street address
Shahid Rajaiei Highway, Emergency Department, Haft-e Tir Tir Hospital
City
Tehran
Province
Tehran
Postal code
1886718136
Phone
+98 21 5522 8580
Fax
+98 21 5522 8580
Email
ir.ac.iums@web7tir
Web page address
http://hospht.iums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kazem Malekuti
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 8670 2503
Email
ir.ac.iums@research
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?