Comparison of intravenous morphine and nebulized lidocaine in acute pain relief in limb trauma patients.
Design
In this study, 100 patients referred to the emergency department with severe acute traumatic trauma were examined. A single dose of nebulized lidocaine, 10 mg / kg, was administered to the intervention group. A single dose of intravenous morphine 0.1 mg / kg was administered to the control group. Patients are randomly divided into two groups by a statistician using statistical software.
Settings and conduct
In this study, 100 patients who referred to the emergency department with acute traumatic trauma were evaluated after obtaining consent, provided that they did not have any restrictions on the participation in the project. Patients were randomly assigned a 10 mg / kg lidocaine nebulizer or morphine Intravenous administration of 0.1mg / kg is prescribed and the severity of pain and vital signs of the patient is specified in minutes 0.10, 20.30, 60. Finally, we analyze the data.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
1- Age over 16 years and under 65 years
2. Traumatic traumatic limbs require pain relief due to extreme pain in the limbs
3. Pain intensity greater than 5 based on NRS scale
4. Satisfaction to enter the study
Exclusion criteria:
1. Disturbance of alertness
2. Hemodynamic impairment during injection of the drug
3. Drug or alcohol use, or pain relief or analgesics over the past 48 hours.
4. Lidocaine and morphine susceptibility
5. Chronic illnesses (heart disease, liver, biliary tract, kidney and lung) according to history and clinical examination.
6. No patient cooperation
7. No consent to enter the study
Intervention groups
Intervention group:Prescribing nebulized lidocaine in patients with acute limb trauma.
Control group:Prescribing intravenous morphine in patients with acute limb trauma.
Main outcome variables
The amount of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180131038569N1
Registration date:2018-04-12, 1397/01/23
Registration timing:registered_while_recruiting
Last update:2018-04-12, 1397/01/23
Update count:0
Registration date
2018-04-12, 1397/01/23
Registrant information
Name
Behzad Sadeghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6690 4848
Email address
b.s1367@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intravenous non-vented lidocaine effects in the relief of acute pain in extremity trauma patients
Public title
Comparison of intravenous non-vented lidocaine effects in the relief of acute pain in extremity trauma patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with limb trauma require pain relief with NRS upper 5/10
age between16-65 years
Exclusion criteria:
dissatisfaction of patient from this study
Patient's allergy to lidocaine or morphine
Age
From 16 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
This study is a randomized, double blind clinical trial. All patients with entry criteria at the time of study are considered to be included in this study. After obtaining written consent and explaining the study conditions, patients are asked to rate their pain levels based on the NRS score. They then randomly enter each of the groups under review. The first group was treated with intravenous morphine (0.1 mg / kg, manufactured by Dr. Distribution Co., Tehran, Iran) and the second group with nevulose lidocaine (10mg / kg in saline (100 mg / ml concentration), Caspian Company Medicine, Rasht, Iran) were treated.
Blinding (investigator's opinion)
Double blinded
Blinding description
The grouping of patients will be based on Balanced Block Randomization in two groups A and B. Both the analgesic drugs are in boxes A and B, and only the physician responsible for the plan (supervisor) is aware of the drug content of each group. In the control group intravenous morphine is selected and at the same time is nebulized distilled water as placebo and in the intervention group,nebulized lidocaine, and at the same time, venous injection distilled water for patients will be prescribed.
Then, for use by each supervisor, the numbering is done by the supervisor and what is mentioned in the office.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Imam Khomeini Hospital,Keshavarz Blvd,Tehran
City
Tehran
Province
Tehran
Postal code
1417614418
Approval date
2017-06-12, 1396/03/22
Ethics committee reference number
IR.TUMS.IKHC.REC1396.2600
Health conditions studied
1
Description of health condition studied
درد حاد در اورژانس
ICD-10 code
R52
ICD-10 code description
Pain, unspecified
Primary outcomes
1
Description
Intensity of pain
Timepoint
0,10,20,30,60 minutes
Method of measurement
Numeric Pain Rating Scale
Secondary outcomes
1
Description
Systolic blood pressure
Timepoint
0,10,20,30,60minutes
Method of measurement
MmHg
2
Description
Diastolic blood pressure
Timepoint
0,10,20,30,60minutes
Method of measurement
MmHg
3
Description
Heart rate
Timepoint
0,10,20,30,60minutes
Method of measurement
In a minute
4
Description
Respiratory rate
Timepoint
0,10,20,30,60minutes
Method of measurement
In a minute
5
Description
o2 saturation
Timepoint
0,10,20,30,60minutes
Method of measurement
percent
Intervention groups
1
Description
Intervention group: Lidocaine nebulizer is administered at a dose of 10 mg / kg and is administered intravenously to placebo (distilled water 0.1 cc / kg) for patients.
Category
Treatment - Drugs
2
Description
Control group: Intravenous morphine (0.1 mg / kg) with distilled water as a placebo (10 cc / kg) is nebulized.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital complex
Full name of responsible person
Behzad Sadeghi Amroabadi
Street address
Imam Khomeini Hospital Complex,End of Keshavarz Boulevard,Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2240
Fax
+98 21 6658 1615
Email
Imamhospital@tums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research of Tehran University of Medical Sciences
Full name of responsible person
Dr Shervin Farahmand
Street address
Imam Khomeini Hospital,Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1618
Email
Imamhospital@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research of Tehran 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
Deputy of Research of Tehran University of Medical Sciences
Full name of responsible person
Behzad Sadeghi َAmroabadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Imam Khomeini Hospital,Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417614418
Phone
+98 21 61111
Email
B.s1367@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Deputy of Research of Tehran University of Medical Sciences
Full name of responsible person
Dr Shervin Farahmand
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Imam Khomeini Hospital,Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
Imamhospital@tums.ac
Phone
+98 21 6658 1618
Email
Shervinf1352@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Deputy of Research of Tehran University of Medical Sciences
Full name of responsible person
Behzad Sadeghi Amroabadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Keshavarz Avenue,Enghelab Square
City
Tehran
Province
Tehran
Postal code
Imamhospital@tums.ac
Phone
+98 21 6658 1618
Email
B.s1367@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
Undecided - It is not yet known if there will be 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