1. Home
  2. Approved trials
  3. » فارسی

The effect of Fentanyl and Midazolam on pain control and chronic pain prevention in patients with lower limb fracture

Protocol summary

Study aim
the effect of co-injection of Fentanyl and Midazolam on pain control and chronic pain in patients with lower limb fracture referred to Yasuj Shahid Beheshti Hospital
Design
This study is a double-blind clinical trial in 100 male and female trauma patients aged between 30 and 60 years and 100 patients who undergo elective surgery.
Settings and conduct
Patients with hip fractures in Shaheed Beheshti Hospital undergo surgery.Patients are given a completely randomized infusion of fentanyl, 50 micro-grams per hour, and midazolam, 2 milligrams per hour. All patients are monitored for blood pressure, heart rate, oxygen and level of consciousness .To the second group, morphine, 5 to 10 mg, is injected as needed by the stuffs. In the first 24 hours of admission, pain on 5, 15, 24 hours after admission and starting the mentioned drugs are evaluated. In 24 hours after the operation, the patients are evaluated in the same way 5, 15, 24 hours after the operation.Special forms (a modified McGill pain score and visual acuity score scale) that are described to the patient are filled in by the patient. Following the discharge of the patient from the hospital, patients are followed up monthly for 6 months.
Participants/Inclusion and exclusion criteria
Entry requirements: Patients between 30-60 years of age with fractures of the femoral neck that undergo a non-emergency candidate. Patients with a history of diabetes, addiction, blood pressure, or oral intake drugs, or history of chronic pain, are excluded.
Intervention groups
They have femoral bone fractures and are between 30 and 60 years of age, and candidates are acting,
Main outcome variables
Pain control and prevention of chronic pain in patients with lower limb fractures who have taken midazolam and fentanyl inferior compared to patients taking morphine

General information

Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number: IRCT20111009007745N10
Registration date: 2021-09-19, 1400/06/28
Registration timing: registered_while_recruiting

Last update: 2021-09-19, 1400/06/28
Update count: 0
Registration date
2021-09-19, 1400/06/28
Registrant information
Name
Afshin Mansourian
Name of organization / entity
YUMS
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 0620
Email address
afshin.mansourian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-06, 1400/06/15
Expected recruitment end date
2022-03-06, 1400/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Fentanyl and Midazolam on pain control and chronic pain prevention in patients with lower limb fracture
Public title
The effect of combine fentanyl and midazolam on pain management and prevention of chronic pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
30-60 years old patients with isolated femoral fractures who are not candidated for emergency surgery
Exclusion criteria:
Patients with a history of diabetes, addiction, hypertension, or oral pain relief intake drugs, or history of chronic pain
Age
From 30 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Data analyser
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants and health care personnel are not aware of the combination of injection drugs and health care personnel will not be involved in choosing patients.
Placebo
Not used
Assignment
Parallel
Other design features
does not have

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Ethics committee of Yasuj University of Medical Sciences ,Motehari Blv, Yasuje, Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591875114
Approval date
2020-12-16, 1399/09/26
Ethics committee reference number
IR.YUMS.REC.1399.187

Health conditions studied

1

Description of health condition studied
Control of pain and prevention of chronic pain in patients with lower limb fracture
ICD-10 code
S72
ICD-10 code description
Fracture of femur

Primary outcomes

1

Description
Pain control and prevention of chronic pain in patients with lower limb fractures by Fentanyl Infusion and Midazolam
Timepoint
The effect of fentanyl and midazolam infusion on pain management and prevention of chronic pain in patients with lower extremity fracture The patient's pain is evaluated after five hours, 15 hours, 24 hours from the time of admission and starting the infusion drugs. In 24 hours after the operation, the same procedure is measured 5, 15, 24 hours after the operation. After discharge from the hospital, follow-up is done on monthly through with questionnaires mentioned, and all patients were monitored for 6 months
Method of measurement
Based on McGill's Modified Inventory and Visual Analog Scale

Secondary outcomes

1

Description
Quality of life score
Timepoint
Quality of life scores are assessed 1, 3, and 6 months after discharge from the hospital
Method of measurement
Short questionnaire 12 health questions (SF12), designed by War, Kasinski, Keller

Intervention groups

1

Description
Intervention group: Patients with lower limb fractures who are non-emergency candidates for surgery are selected. In the inpatient ward, informed consent is obtained to participate in the study. Numerical pain scale with a range of zero to ten) is given to the patient by the patient with the help of special emoticons describing the pain and a special ruler for this task. Then, at 5, 15 and 24 hours from the time of admission, the patient's pain intensity is evaluated and recorded. Patients are divided into two groups. The group that injects midazolam and fentanyl into the patient by infusion with a pump syringe starts from the time of hospitalization and continues up to 24 hours after the operation. Morphine is injected
Category
Treatment - Drugs

2

Description
Control group: Control of pain in patients with lower limb fractures, these patients are given morphine if needed.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Afshin Mansourian
Street address
Red Cross Crescent, Motahari St., Shahid Beheshti Hospital
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591794857
Phone
+98 74 3322 0620
Fax
Email
beheshtihopital@yasooj.ir
Web page address
http://beheshti.yums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Hossin Oryad
Street address
Deputy of Research and Technology, Yasuj University of Medical Sciences, Shahid Motahari Blvd,Yasuj,Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3333 7231
Fax
+98 74 3333 7230
Email
oryadhsn@gmail.com
Web page address
https://research.yums.acair
Grant name
Grant code / Reference number
نشده است
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Afshin Mansourian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
38/5000 Shahid Motahari Boulevard, Shahid Beheshti Hospital
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591794857
Phone
+98 74 3322 4721
Email
afshin.mansourian@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Afshin Mansourian
Position
َAssistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
operating room, Shahid beheshti Hospital, Shshid Montazeri BLV ,Yasuje,Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591794859
Phone
+98 74 3322 4721
Email
afshin.mansourian@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Afshin Mansourian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Operating Room,Shahide Behshti Hospital ,Shahide Montazeri BLv,
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591794857
Phone
+98 987433224721
Email
Afshin.mansourian@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Unknown
When the data will become available and for how long
Unknown
To whom data/document is available
Unknown
Under which criteria data/document could be used
Unknown
From where data/document is obtainable
Unknown
What processes are involved for a request to access data/document
Unknown
Comments
Loading...