Protocol summary

Summary
A prospective double blind randomized clinical trial was performed in Imam Reza teaching hospital in Tabriz-Iran. Two hundred forty patients presenting to ED with renal colic (age= 18-65 years old) were enrolled in two equal groups (I,II). In group I, we used parenteral lidocaine (approximately 1.5 mg/kg) slowly and in group II, we used morphine (approximately 0.1 mg/kg) slowly. Our exclusion criteria were lidocaine or morphine sensitivity, renal failure, ischemic heart disease, abnormal ECG, Liver insufficiency and pregnancy. Pain explained by patients, based on VAS (Visual Analogue Scale) was recorded at the time of entrance to Emergency medicine Department, and in 5, 10, 15 and 30 minutes after injection.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138901042496N3
Registration date: 2010-03-24, 1389/01/04
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2010-03-24, 1389/01/04
Registrant information
Name
Hassan Soleimanpour
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1329 1286
Email address
soleimanpourh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Vice chancellor of Tabriz University of Medical Sciences
Expected recruitment start date
2009-09-23, 1388/07/01
Expected recruitment end date
2010-07-23, 1389/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of intravenous Lidocaine versus Morphine for patient with Renal Colic in the Emergency Department in Imam REZA Hospital ,Tabriz University of Medical Siences
Public title
Effectiveness of intravenous Lidocaine versus Morphine for patient with Renal Colic in the Emergency Department in Imam REZA Hospital ,Tabriz University of Medical Siences
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with renal colic (age= 18-65 years old) Exclusion criteria: Lidocaine or morphine sensitivity, renal failure, ischemic heart disease, abnormal ECG, Liver insufficiency, pregnancy.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 240
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Vice chancellor of Tabriz University of Medical Sciences
Street address
Research Vice chancellor of Tabriz University of Medical Sciences ,Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN
City
Tabriz
Postal code
51664
Approval date
2009-12-01, 1388/09/10
Ethics committee reference number
8712

Health conditions studied

1

Description of health condition studied
Renal Colic
ICD-10 code
N20.0
ICD-10 code description
Stone in kidney

Primary outcomes

1

Description
Pain
Timepoint
On arrival to Emergency room and at 5, 10,15, and 30th minutes following intervention
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intravenous lidocaine
Category
Treatment - Drugs

2

Description
Intravenous morphine
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam reza hospital
Full name of responsible person
Dr.Hassan Soleimanpour
Street address
Emergency Medicine Department, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN.
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Vice chancellor of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mir Ali Eteraf Oskouei
Street address
Research Vice chancellor of Tabriz University of Medical Sciences ,Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice chancellor of Tabriz University 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
Tabriz University of Medical Sciences
Full name of responsible person
Hassan Soleimanpour
Position
Anesthesiologist/Assistant professor of Anesthesiology, MD
Other areas of specialty/work
Street address
Emergency Medicine Department, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN.
City
Tabriz
Postal code
51664
Phone
+98 41 1335 2078
Fax
Email
h_mofid1357@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hassan Soleimanpour
Position
Anesthesiologist/Assistant professor of Anesthesiology, MD
Other areas of specialty/work
Street address
Emergency Medicine Department, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN.
City
Tabriz
Postal code
51664
Phone
+98 41 1335 2078
Fax
Email
h_mofid1357@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hassan Soleimanpour
Position
Anesthesiologist/Assistant professor of Anesthesiology, MD
Other areas of specialty/work
Street address
Emergency Medicine Department, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN.
City
Tabriz
Postal code
51664
Phone
+98 41 1335 2078
Fax
Email
h_mofid1357@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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