Evaluation of intravenous lidocaine in comparison with intravenous morphine in patients referred to Imam Khomeini hospital with right upper abdominal pain and suspected billiary colic during 2016-18
Pain relief, expedite digestive function, reducing the duration of hospitalization
Design
randomized blinded clinical trial with a parallel group design recruiting 100 patients
Settings and conduct
After receiving consent, drugs will deliver to the Head nurse based on 0 and 1 sequence. Drugs include intravenous morphine 5 miligram and intravenous lidocaine 100 miligram that inject to patient with the same shape and volume, then we study vital signs and severity of the pain.
Participants/Inclusion and exclusion criteria
based on location and severity of pain and past medical history
Intervention groups
The group that have biliary colic and treat with intravenous lidocaine
Main outcome variables
severity of pain and drug complications, blood pressure, raspiratory rate, pulse rate, oxygen saturation and resque dose
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161121030993N2
Registration date:2018-02-23, 1396/12/04
Registration timing:retrospective
Last update:2018-02-23, 1396/12/04
Update count:0
Registration date
2018-02-23, 1396/12/04
Registrant information
Name
Tayebeh Pouryousefi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2240
Email address
t-pouryousefi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2017-01-07, 1395/10/18
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
2017-01-07, 1395/10/18
Actual recruitment end date
2018-01-08, 1396/10/18
Trial completion date
empty
Scientific title
Evaluation of intravenous lidocaine in comparison with intravenous morphine in patients referred to Imam Khomeini hospital with right upper abdominal pain and suspected billiary colic during 2016-18
Public title
Comparison of Lidocaine Effect with Venous Morphine in Patients with Billiary Colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
upper abdominal pain score more than 5/10
past biliary history
positive morphy sign
positive sonography
Exclusion criteria:
renal failure
hepatic failure
heart block
wolf-parkinson-white syndrome
betablocker user or cimethidine user
weight under 40 kilogram
weight over 90 kilogram
Age
From 18 years old to 64 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment by Statistician with software
Blinding (investigator's opinion)
Double blinded
Blinding description
Medications in the 5cc syringes are treated with morphine valodicin in accordance with the sequences 0 and 1, which are delivered to the head nurse.Patients and researcher are blind.
Placebo
Not 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
16Azar Avenue,Enghelab Square,Tehran
City
Tehran
Province
Tehran
Postal code
1417614418
Approval date
2017-01-07, 1395/10/18
Ethics committee reference number
IR.TUMS.IKHC.REC.1395.1425
Health conditions studied
1
Description of health condition studied
Billiary stone
ICD-10 code
K80
ICD-10 code description
Cholelithiasis
Primary outcomes
1
Description
Intensity of pain
Timepoint
At minutes: 0, 10, 20, 30, 45, 60 and120
Method of measurement
Numeric Rating Scale Score
Secondary outcomes
1
Description
Blood Pressure
Timepoint
0, 20, 60 minutes after
Method of measurement
Barometer device
2
Description
pulse rate
Timepoint
0, 10, 20, 30, 45, 60, 120 minutes after
Method of measurement
minute
3
Description
Respiratory rate
Timepoint
0, 20, 60 minutes after
Method of measurement
minute
4
Description
Oxygen saturation
Timepoint
0, 20, 60 minutes after
Method of measurement
pulse oxymeter device
5
Description
Numeric Rating Scale Score
Timepoint
0, 10, 20, 30, 45, 60, 120 minutes after
Method of measurement
Numeric range from 0 to 10
Intervention groups
1
Description
Patients with acute Billiary Colic with NRS above 5/10 that taking 100 miligram Intravenous Lidocaine
Category
Treatment - Drugs
2
Description
Control group: Patients with acute Billiary Colic with NRS above 5/10 that taking 5 miligram Intravenous Morphine