Protocol summary

Summary
To compare the analgesic effects of intravenous (IV) ketamine with IV ketorolac in acute renal colic . This is a randomized double blind clinical trial and all patient who come to emergency department with acute renal colic ( diagnosed by past history and clinical sign) and signed inform consent form and have not exclusion criteria of the study( unwilling to study participation, drug allergy and ets) , include to the trial. The study population is 126 patients . With block randomization each patients allocated to one of two groups. Group 1, receive 0.6 mg/kg intravenous ketamine as analgesic group2, receive 30 mg intravenous ketorolac as analgesic. All patients will undergo pain intensity measurement by Numeric Rating Scale (NRS) from 0 to 10. At the beginning of study and after 5,15,30,60 and 120 min of intervention we calculate pain level of patients with using of Numeric Rating Scale. We use 0.1 mg/kg morphin sulfat as rescue analgesic if persistent pain . The reduction in Numeric Rating Scale of pain and complications at 0, 5, 15, 30 , 60 , 120 minute and need for rescue analgesia will be recorded and the difference between these values will be evaluated by statistical methods.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017021932660N1
Registration date: 2017-06-06, 1396/03/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-06-06, 1396/03/16
Registrant information
Name
Mozhgan Farmahini Farahani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7784 4341
Email address
farmahinif-m@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-03-19, 1394/12/29
Expected recruitment end date
2017-06-21, 1396/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of analgesic effect of intravenous low dose Ketamine and intravenous ketorolac ,in management of the acute pain in renal colic patients who admitted to the emergency department
Public title
Analgesic effect of intravenous ketamine in patients with renal colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all patient with high clinical suspicious of renal colic; all patient who come with pain and have clinical or lab data of renal colic. Exclusion criteria: age < 18 years; unwilling to study participation; past history of allergy to ketorolac or ketamine; Pregnancy or probable pregnancy; Breast feeding; history of analgesic drug consumption < 4 hours ago; liver; renal or heart failure patients; decrease level of consciousness; mental disability;fibromyalgia; Vascular lesions and brain lesions; History of opium addiction; Psychosis; Refusal of the patients from the participation;Head and eyes trauma
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 126
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
Tehran University of Medical Sciences , Department of Medical Research
Street address
No. 1 , North door of Tehran university , Poursina street, Enghelab street Tehran
City
Tehran
Postal code
Approval date
2015-09-19, 1394/06/28
Ethics committee reference number
IR.TUMS.REC.1394.786

Health conditions studied

1

Description of health condition studied
Renal colic
ICD-10 code
N20
ICD-10 code description
Calculus of kidney and ureter

Primary outcomes

1

Description
The pain of kidney stones
Timepoint
0 , 5 , 15 , 30 , 60 , 120 min
Method of measurement
Numeric Rating Scale

Secondary outcomes

1

Description
Hypertention
Timepoint
5, 15,30,60,120 min after intervention
Method of measurement
Using a questionnaire , Measurement of vital signs

2

Description
Tachycardia
Timepoint
5, 15,30,60,120 min after intervention
Method of measurement
Using a questionnaire, measurement of vital signs

3

Description
Nausea
Timepoint
5, 15,30,60,120 min after intervention
Method of measurement
Using a questionnaire

4

Description
Dizziness
Timepoint
5, 15,30,60,120 min after intervention
Method of measurement
Using a questionnaire

5

Description
Agitation
Timepoint
5, 15,30,60,120 min after intervention
Method of measurement
Using a questionnaire

Intervention groups

1

Description
In Group A, patients receive a dose of 0.6mg / kg intravenous ketamine.Pain severity base on NRS and complication such as hypertention,Tachycardia ,nausea ,dizziness,agitation , will be recorded at 5th, 15th, 30th ,60th and 120th minute.Persistent pain after receive drug ,0.1 mg/kg of intravenous morphine will be administrated as rescue analgesia .
Category
Treatment - Drugs

2

Description
In Group B, patients receive a dose of 30mg intravenous ketorolac.Pain severity base on NRS and complication such as hypertention,Tachycardia ,nausea ,dizziness,agitation , will be recorded at 5th, 15th, 30th ,60th and 120th minute.Persistent pain after receive drug ,0.1 mg/kg of intravenous morphine will be administrated as rescue analgesia .
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr Mozhgan Farmahini Farahani
Street address
Sina Hospital , Hsan Abad Square , Imam Khomeini Street , Tehran
City
Tehran

2

Recruitment center
Name of recruitment center
Emam Khomaini Hospital
Full name of responsible person
Dr Mozhgan Farmahini Farahani
Street address
Emam Khomaini Hospital , End of Keshavarz Blv , Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical sciences
Full name of responsible person
Shahin Akhund zadeh
Street address
Room 206 , 1th floor , Building 1 , Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical sciences
Full name of responsible person
Dr Mozhgan Farmahini Farahani
Position
MD
Other areas of specialty/work
Street address
Emam Khomaini Hospital , Ene of Keshavarz Blvd , Tehran
City
Tehran
Postal code
Phone
+98 21 7784 4341
Fax
Email
farahanimozhgan@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mehran Sotoodenia
Position
Assistant Professor , Emergeny Medicine Specialist
Other areas of specialty/work
Street address
Emergency Department of Sina Hospital , Emam Khomaini Street , Hassan Abad Square
City
Tehran
Postal code
Phone
+98 21 6634 8500
Fax
Email
Msotoodeh@ymail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mehran Sotoodehnia
Position
Assistant Professor , Emergeny Medicine Specialist
Other areas of specialty/work
Street address
Sina Hospital , Hsan Abad Square , Imam Khomeini Street
City
Tehran
Postal code
Phone
00
Fax
Email
Msotoodeh@ymail.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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