Comparison of analgesic effects and morphine consumption of intravenous morphine sulfate and intranasal dexmedetomidine with intravenous morphine sulfate in patients with extremity fractures presented in emergency departments
Comparison of analgesic effects and morphine consumption of intravenous morphine sulfate and intranasal dexmedetomidine with intravenous morphine sulfate in patients with extremity fractures presented in emergency department
Design
The design of the study is a randomized clinical trial. The randomization method is blocked. The sample size for each study group is 30.
Settings and conduct
In this research, all patients referred to the Emergency Department of Shohada-e- Haftome tir , Hazrat Rasoul Akram and Firouzgar Hospital, who suffered from extremity fractures will be enrolled. Patients will be randomly divided into two groups based on 10 blocks. A total of 60 patients will be examined. Patients and data analyzers will be blind.
Participants/Inclusion and exclusion criteria
All patients referred to the Emergency Department of Shohada-e- Haftome tir , Hazrat Rasoul Akram and Firouzgar Hospital, who suffered from extremity fractures will be enrolled. Inclusion criteria: Organ trauma leading to acute fractures, Patients over the eighteen years old. Exclusion criteria: Loss of consciousness, Chronic kidney and coronary artery disease, Pregnancy, Drinking alcohol and drugs.
Intervention groups
In intervention group, Patients will receive intravenous morphine sulfate at a dose of 5 mg plus intranasal dexmedetomidine 10 mg per kg of body weight. In control group, Patients will receive morphine at a dose of 5 mg plus a nasal placebo that will be distilled water.
Main outcome variables
Severity of pain after prescribing, Total dosage of the drug.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111114008104N15
Registration date:2019-01-02, 1397/10/12
Registration timing:prospective
Last update:2019-01-02, 1397/10/12
Update count:0
Registration date
2019-01-02, 1397/10/12
Registrant information
Name
Mohammad Amin Zare
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6652 5327
Email address
ma-zare@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-05, 1397/10/15
Expected recruitment end date
2019-05-05, 1398/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of analgesic effects and morphine consumption of intravenous morphine sulfate and intranasal dexmedetomidine with intravenous morphine sulfate in patients with extremity fractures presented in emergency departments
Public title
Effect of intravenous morphine sulfate and intranasal dexmedetomidine on Patients' Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Organ trauma leading to acute fractures
Patients over the eighteen years old
Exclusion criteria:
Loss of consciousness
Chronic kidney and coronary artery disease
Pregnancy
Drinking alcohol and drugs
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to two groups. In order to randomize, a random block method will be used. For this purpose, we formed blocks with 10 person. In each block, 5 individuals will be in intervention group and 5 will be in control group. A total of 6 blocks will be considered for sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
Data will analyze by person who is blind to study groups, and patients will also be unaware of the type of treatment.
Placebo
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
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-07-26, 1396/05/04
Ethics committee reference number
IR.IUMS.REC.1397.566
Health conditions studied
1
Description of health condition studied
extremity fracture
ICD-10 code
M84.4
ICD-10 code description
Pathological fracture, not elsewhere classified
Primary outcomes
1
Description
Severity of pain after prescribing
Timepoint
After 15, 30, 60 and 120 minutes after using the drug
Method of measurement
From 1 to 10 (Based on numerical scale).
2
Description
Total dosage of the drug
Timepoint
After the end of treatment
Method of measurement
Based on the information in the patient file
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients will receive intravenous morphine sulfate at a dose of 5 mg plus intranasal dexmedetomidine 10 mg per kg of body weight.
Category
Treatment - Drugs
2
Description
Control group: Patients will receive morphine at a dose of 5 mg plus a nasal placebo that will be distilled water.