Evaluation of Analgesic effect of intravenous lidocaine versus intravenous morphine sulfate in pain reduction in long or short bones fractures of upper and lower limbs
Perpose of study:Evaluation of Analgesic effect of intravenous lidocaine versus intravenous morphine sulfate in pain reduce in bone fractures
Design study:Randomized (Sealed Envelope).double blind (both medicine administrator and patient aren,t aware of type of medicine.)
The study population:The patients with bone fracture
Inclusion criterias:All patients 15-65 years of age with long or short upper or lower bone fracture
Exclusion criterias: Persons under 15 years; People over 65 years; Pregnant and lactating women; People with loss of consciousness; Hemodynamic disorder; Traumatic patients with evidence of intra abdominal or intra pelvic hemorrhage; Mental retard patients; History of allergy to lidocaine or morphine; People with underlying disease (coronary artery disease; Diabetes; Heart valvular disease; History of cardiac arrhythmia; Hypertention; Cerebrovascular disease; Seizure; History of liver or renal disease); History of heart drugs; History of addiction
The sample size: about 280
Intervention: Intra venous Lidocaine
Intervention time: After primary physical exam, cardiac monitoring and VAS score calculation
The primary outcome expected: pain
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015052622423N1
Registration date:2015-10-21, 1394/07/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-21, 1394/07/29
Registrant information
Name
Hamide Shiri
Name of organization / entity
Ahvaz Jondi Shapoor University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 33738383
Email address
shiri.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for reseach of Ahvaz Joundishapur University of Medical Sciences .Dr Saki Nader
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Analgesic effect of intravenous lidocaine versus intravenous morphine sulfate in pain reduction in long or short bones fractures of upper and lower limbs
Public title
Evaluation of Analgesic effect of intravenous lidocaine versus intravenous morphine sulfate in pain reduction in long or short bones fractures of upper and lower limbs
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteris : All patients 15-65 years of age with long or short upper or lower bone fracture, referring to emergency ward of Imam Khomeini and Golestan hospital in Ahwaz city.
Exclusion criterias: Persons under 15 years; People over 65 years; Pregnant and lactating women; People with loss of consciousness; Hemodynamic disorder ; Traumatic patients with evidence of intra abdominal or intra pelvic hemorrhage ; mental retard patients; History of allergy to lidocaine or morphine; People treated with NA; People with underlying disease (Coronary artery disease ; Diabetes; Heart valvular disease; history of Cardiac arrhythmia; Hypertention; Cerebrovascular disease; seizure; history of liver or renal disease); history of heart drugs; history of addiction
Age
From 15 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
280
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization is accomplished with sealed envelopes.Both lidocaine and morphine are colorless and odorless.To homogenize their volume, drugs are vaccumed in a 10 cc syringe according to the name of the drug, which is inside the sealed envelope by a person other then the drug administrator and the total volume is raised up to 10 cc with distilled water.then it would be injected to the patient by administrator.The administrator is unawar of type of drug .
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundi shapoor University of Medical Sciences
Street address
Ground floor, Vice Chancellor for research of Ahwaz Jundishapoor University of Medical Sciences,univercity city, Ahwaz city
City
Ahvaz
Postal code
61357-15794
Approval date
2015-05-09, 1394/02/19
Ethics committee reference number
IR.AJUMS.REC.1394.63
Health conditions studied
1
Description of health condition studied
Fracture
ICD-10 code
S52
ICD-10 code description
Fracture of forearm
2
Description of health condition studied
farcture
ICD-10 code
S62
ICD-10 code description
Fracture at wrist and hand level
3
Description of health condition studied
fracture
ICD-10 code
S00-T98
ICD-10 code description
Other fractures of long or short bones
4
Description of health condition studied
Fracture
ICD-10 code
S42
ICD-10 code description
Fracture of shoulder and upper arm
5
Description of health condition studied
fracture
ICD-10 code
S72
ICD-10 code description
Fracture of femur
6
Description of health condition studied
fracture
ICD-10 code
S82
ICD-10 code description
Fracture of lower leg, including ankle
7
Description of health condition studied
fracture
ICD-10 code
S92
ICD-10 code description
Fracture of foot, except ankle
Primary outcomes
1
Description
pain
Timepoint
0-5-10-15-20-25-30-minute
Method of measurement
vas score
Secondary outcomes
1
Description
Blood pressure
Timepoint
0-10-15-20-25-30 minute
Method of measurement
with manometer
2
Description
Pulse rate
Timepoint
0-10-15-20-25-30 minute
Method of measurement
Count per minute
3
Description
spo2
Timepoint
0-10-15-20-25-30 minute
Method of measurement
with pulse oximetry
4
Description
respiratory rate
Timepoint
0-10-15-20-25-30 minute
Method of measurement
Count per minute
Intervention groups
1
Description
Control group:Intra venous morphine 0.1mg/kg bolus during 2 minutes
Category
Treatment - Drugs
2
Description
Intervention group:Intra venous Lidocaine 1.5 mg/kg bolus during 2 minutes
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Dr Arash Forouzan
Street address
Golestan educational and medical center, Farvardin street, Ahwaz city
City
ahvaz
2
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Dr Hamide shiri
Street address
Imam Khomeini educational and medical center, Azadegan street, Ahwaz city
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Ahvaz Jundishapoor Univercity of Medical Sciences
Full name of responsible person
Dr Saki Nader
Street address
Ground floor, Vice chancellor for research of Ahvaz Jundishapoor Univercity of Medical Sciences, univercity city, Ahwaz city
City
Ahvaz
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research Ahvaz Jundishapoor Univercity of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz Jundishapoor University of Medical Sciences
Full name of responsible person
Hamide Shiri
Position
MD, Emergency medicine resident
Other areas of specialty/work
Street address
Azadegan sreert, Imam khomeini hospital, Ahwaz city
City
Ahwaz
Postal code
-
Phone
+98 613332477
Fax
-
Email
shiri.h.@ajums.ac.ir؛tufan16671@yahoo.com
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahwaz Jundishapoor univercity of medical science
Full name of responsible person
Dr Arash Forouzan
Position
Emergency medicine physician
Other areas of specialty/work
Street address
Azadegan sreert, Imam khomeini hospital, Ahwaz city
City
Ahvaz
Postal code
-
Phone
+98 61 3333 2477
Fax
-
Email
Arash-Forouzan@ajums.ac.ir
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
Ahwaz Junishapoor univercity of medical science
Full name of responsible person
Dr Arash Forouzan
Position
Emergency medicine physician
Other areas of specialty/work
Street address
Azadegan sreert, Imam khomeini hospital, Ahwaz city
City
Ahvaz
Postal code
-
Phone
+98 61 3333 2477
Fax
-
Email
Arash-Forouzan@ajums.ac.ir
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)