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Effects of adding intravenous lidocaine and morphine on pain of acute renal colic

Protocol summary

Summary
The aim of this randomized double-blind clinical trial is to compare of effects of intravenous lidocaine and morphine on acute renal colic pain. A total of 120 patients, meeting eligibility criteria, will be randomly allocated into two equal groups. In the intervention group 1.5 mg/kg IV lidocaine with 0.1 mg/kg IV morphine and in the control group 0.1 mg/kg IV morphine with intravenous saline as placebo will be administered. All syringes were covered with masking tape and physicians are unaware of its contents. A nurse (A Blinded observer) pain, nausea and vomiting in patients before treatment, and at 5, 10, 30, 60 and 120 minutes after the intervention will be recorded by the standard Visual Analog Scale. In addition, patient information such as age, sex, education, history of kidney stone, history of lithotripsy, renal involvement (left, right, or both), presence or absence of hydronephrosis on ultrasound and medication before visiting in the emergency department will be recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201404196803N7
Registration date: 2014-04-24, 1393/02/04
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-04-24, 1393/02/04
Registrant information
Name
Abolfazl Firouzian
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1222 6655
Email address
a.firouzian@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2014-04-30, 1393/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of adding intravenous lidocaine and morphine on pain of acute renal colic
Public title
The effect of lidocaine on acute renal colic pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Informed written consent; Clinical signs of renal colic with at least one of the three cases, hematuria in urinalysis, seeing stone in radiography (Kidney Ureter Bladder = KUB) and sonography of the urinary tract. Exclusion criteria: Patient's unwillingness to continue participation in the study at any time; History of cardiac disease, hypertension and asthma; Pregnancy; substance abuse; History of frequent acute renal colic (more than 3 times per year); Sensitivity to lidocaine.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Moallem Square.
City
Sari
Postal code
4817844718
Approval date
2013-02-27, 1391/12/09
Ethics committee reference number
91-218

Health conditions studied

1

Description of health condition studied
Acute renal colic pain
ICD-10 code
N23
ICD-10 code description
Unspecified renal colic

Primary outcomes

1

Description
Acute renal colic pain
Timepoint
Before intervention, and at 5, 10, 30, 60 and 120 minutes after the intervention
Method of measurement
Visual Analog Scale

Secondary outcomes

1

Description
Nausea and vomiting due to acute renal colic
Timepoint
Before intervention, and at 5, 10, 30, 60 and 120 minutes after the intervention
Method of measurement
Visual Analog Scale

Intervention groups

1

Description
In the intervention group 1.5 mg/kg IV lidocaine with 0.1 mg/kg IV morphine will be administered.
Category
Treatment - Drugs

2

Description
In the control group 0.1 mg/kg IV morphine with intravenous saline as placebo will be administered.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Khomeini Hospital
Full name of responsible person
Abolfazl Firouzian MD, Assistant Professor
Street address
Emam Khomeini Hospital, Amir mazandarani Ave.
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati MD
Street address
Mazandaran University of Medical Sciences, Moallem Square.
City
Sari
Grant name
10506
Grant code / Reference number
91-218
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mazandaran 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Abolfazl Firouzian MD
Position
Anesthesiologist, Assistant Professor
Other areas of specialty/work
Street address
Emam Khomeini Hospital, Amir mazandarani Ave.
City
Sari
Postal code
4814839953
Phone
+98 15 1227 5038
Fax
+98 15 1227 5038
Email
A.firouzian@mazums.ac.ir; Ab.firouzian@gmail.com
Web page address
www.mazums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Abolfazl Firouzian MD
Position
Anesthesiologist, Assistant Professor
Other areas of specialty/work
Street address
Emam Khomeini Hospital, Amir mazandarani Ave.
City
Sari
Postal code
4814839953
Phone
+98 15 1227 5038
Fax
+98 15 1227 5038
Email
A.firouzian@mazums.ac.ir; Ab.firouzian@gmail.com
Web page address
www.mazums.ac.ir

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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