Comparison of the effect of fentanyl with fentanyl and midazolam in pain control in patients with limb trauma
Design
Parallel clinical trial with control group, triple blind , randomized using Random allocation software, on 78 limb traumatic patients
Settings and conduct
The study will be performed on limb trauma patients admitted to the emergency room of Imam Hossein Hospital in Shahroud.
The intervention group will receive fentanyl and midazolam.
The control group will receive fentanyl and placebo.
Primary and secondary outcomes will be assessed in all patients before injection, 30 and 60 minutes after injection.
Patients, outcome assessors (emergency medicine specialists), statistical analyzers using codes that do not know which ones to assign to the groups will be blinded in this study.
In all patients, two identical intravenous injections will be performed without knowing the contents of the injected drug.
Participants/Inclusion and exclusion criteria
Conditions for study before randomization
1- People in the age group of 18 to 80 years
2. Mechanism of trauma Direct trauma
3. Obtaining conscious consent
4. The patient is fully conscious.(GCS=15)
5.Unstable hemodynamic status including patients with blood pressure less than 90 mm Hg
Major conditions of non-inclusion before randomization
1. Pregnancy
2. Mentally retarded patient
3. Patients addicted to drugs
4. Consumption of psychotropic drugs
Intervention groups
In this study, interventions are divided into two groups: intervention and control.
In the control group, fentanyl is injected intravenously and slowly as a placebo based on macro grams per kilogram and one milligram of normal saline. Fentanyl and midazolam are given slowly and intravenously to reduce pain.
Main outcome variables
Determining and comparing the level of pain and anxiety of patients in the two groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201226049832N1
Registration date:2021-04-19, 1400/01/30
Registration timing:prospective
Last update:2021-04-19, 1400/01/30
Update count:0
Registration date
2021-04-19, 1400/01/30
Registrant information
Name
Mozhgan Sabzevari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3223 2986
Email address
sabzevari@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-25, 1400/02/05
Expected recruitment end date
2022-01-19, 1400/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of fentanyl with fentanyl and midazolam in controlling pain in trauma patients
Public title
Comparison of the effect of fentanyl with fentanyl and midazolam in pain control
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
People in the age group of 18 to 80 year
Mechanism of trauma multiple trauma and direct trauma
Obtaining informed consent
Stable hemodynamic status (including patients with systolic blood pressure above 90 mm Hg)
Patient consciousness is complete (GCS = 15)
Exclusion criteria:
Pregnancy.Mentally retarded patients
Mentally retarded patients
Consumption of psychotropic drugs
Drug addicted patients
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into 2 groups of 39 using Random allocation software.From the first eligible patient, the criteria for inclusion of treatment allocation based on randomization will beginInitially, the number 1 to 78 will be written on 78 envelopes, respectively.Then, inside each envelope, a sheet containing the code of the type of treatment of each patient will be specified based on the Random allocation software, which will determine the treatment of each patient.The written consent form of the study will be placed .After the arrival of each patient or identification in accordance with the criteria for entering an envelope in the order of the numbers that the type of treatment will be assigned in code.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participant: The use of placebo in addition to the current drug in one group of fentanyl and normal saline injections and in the second group of fentanyl and midazolam injections.
Outcome Evaluator: Measuring the patient's pain before and after the intervention by an emergency medicine resident who is unaware of how medications are administered to the patient.The data analyzer is not aware of how drugs are assigned to groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
research ethic committee Shahroud university of medial science
Street address
Shahroud University of Medical Sciences and Health Services, Hafte Tir Square
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷۷۳۹۴۷
Approval date
2021-03-08, 1399/12/18
Ethics committee reference number
IR.SHMU.REC.1400.010
Health conditions studied
1
Description of health condition studied
Trauma
ICD-10 code
G89.11
ICD-10 code description
Acute pain due to trauma
Primary outcomes
1
Description
pain control in patient trauma
Timepoint
at the time of referral , 30 and 60 minutes after the intervention
Method of measurement
using the Visual Analogue Scale
Secondary outcomes
1
Description
Side effects of medications
Timepoint
30 and 60 minutes after the intervention
Method of measurement
Examination by a specialist
2
Description
Level of anxiety
Timepoint
At the time of referral, 60 minutes after referral
Method of measurement
Depression Anxiety Stress Scale
Intervention groups
1
Description
Fentanyl injection based on weight levels (Weight 40 to 50 kg at 45 micrograms. Weight 50 to 60 kg at 55 micrograms. Weight 60 to 70 micrograms at 65 micrograms. Weight 70 to 80 kg at 75 micrograms. Weight 80 to 90 kg at 85 micrograms. Weight 90 to 100 kg and above 100 micrograms) and inject one milligram of normal saline
Category
Treatment - Drugs
2
Description
Intervention group: Intravenous midazolam injection (1 mg under 50 kg. 2 mg 50 to 75 kg and 3 mg over 75 kg weight) and intravenous fentanyl injection based on weight levels (40 to 50 kg at 45 μg. 50 to 60 kg at 55 μg) Weight 60 to 70 micrograms at a rate of 65 micrograms. Weight 70 to 80 kg at a rate of 75 micrograms. Weight 80 to 90 kg at a rate of 85 micrograms. Weight 90 to 100 kg and above 100 micrograms)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emergency department Emam Hossein hospital
Full name of responsible person
Mozhgan Sabzevari
Street address
Shafa square, Emam Hossein hospital
City
Shahroud
Province
Semnan
Postal code
1666666666
Phone
+98 23 3234 2000
Email
sabzevari@shmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hassan Emamian
Street address
Shahroud University of Medical Sciences and Health Services, Hafte Tir Square, Shahroud, Iran
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 0428
Email
emamian@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
mozhgan sabzevari
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Shahroud. 7th Tir Square. Shahroud University of Medical Sciences. School of Medicine. Third floor. Room 409
City
shahrood
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5009
Email
dr.sabzevari7@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mozhgan Sabzevari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Shahroud, Tehran St., 7th of Tir Square, Shahroud University of Medical Sciences, School of Medicine, Second Floor, Research Deputy
City
Shahrood
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5009
Email
dr.sabzevari7@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Ms. Sepideh Mahdavi
Position
Statistics Consultant
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
shahroud. 7th of Tir Square. Tehran St.. Shahroud University of Medical Sciences. Faculty of Medical Sciences. Third Floor. Room 409
City
Shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5009
Email
s.mahdavi88@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All collected data will be shared after identifying individuals and analyzing them.
When the data will become available and for how long
The end of the year 1401
To whom data/document is available
For all researchers
Under which criteria data/document could be used
For use in studies
From where data/document is obtainable
Supervisor
What processes are involved for a request to access data/document