To evaluation of intra-nasal ketamine versus intravenous morphine in renal colic pain control in emergency patients
Design
In a phase 3, parallel group, double blind, randomized controlled trial with a simple, individual randomization by using www.randomization.com website; patients older than 18 years old and a complaint of renal colic will be studied in intranasal ketamine or intravenous morphine groups. Each group will have 100 participants.
Settings and conduct
Patients who admitted with renal colic in emergency department of Imam Reza hospital, Tabriz, Iran, will receive treatment by application of study protocol. The participants will be blinded to their treatment group and a placebo will be used. Pain will be scored by using visualize analogue scale. Data will be analyzed by a data analyzer who will be blinded to treatment groups.
Participants/Inclusion and exclusion criteria
Patients older than 18 year old and with a complaint of renal colic will be included in this study and patients younger than 18 year old, patients with a history of allergy to ether ketamine or morphine or patients who received analgesic prior to emergency admission will be excluded.
Intervention groups
Intervention group will receive 1 Mg/Kg of ketamine as nasal spray and 1 CC intravenous normal saline as placebo.
Control group will receive 0.1 Mg/Kg of intravenous morphine and four saline puffs of saline nasal spray as placebo.
Main outcome variables
Pain score 15, 30 and 60 minutes after drug administration.
General information
Reason for update
Acronym
INKmor
IRCT registration information
IRCT registration number:IRCT20121010011067N4
Registration date:2019-05-18, 1398/02/28
Registration timing:registered_while_recruiting
Last update:2019-05-18, 1398/02/28
Update count:0
Registration date
2019-05-18, 1398/02/28
Registrant information
Name
Mahboub Pouraghaei
Name of organization / entity
Tabriz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 2078
Email address
pouraghaeim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-15, 1398/02/25
Expected recruitment end date
2019-06-15, 1398/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Intra-nasal Ketamine Vs. intravenous morphine in renal colic pain control in emergency patients
Public title
Intra-nasal Ketamine Vs. intravenous morphine in renal colic pain control in emergency patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
More than 18 year old
Patients with acute renal colic pain
Exclusion criteria:
Sensitivity to either ketamine or morphine
Recent analgesic use before admition
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
simple, individual randomization by using www.randomization.com website.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and data analyser will be blinded about the treatment method in each treatment group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee 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
Province
East Azarbaijan
Postal code
5166614776
Approval date
2019-04-08, 1398/01/19
Ethics committee reference number
IR.TBZMED.REC.1398.006
Health conditions studied
1
Description of health condition studied
unspecified renal colic
ICD-10 code
N23
ICD-10 code description
Unspecified renal colic
Primary outcomes
1
Description
Pain control
Timepoint
0, 15, 30 and 60 minutes after intervention
Method of measurement
Visual analog scale for pain
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: One Mg/Kg Ketamine (Rotexmedica pharmaceutical co, Germany) will be administrated intranasaly by a nasal spray. One CC on normal saline will injected intravenously as placebo.
Category
Treatment - Drugs
2
Description
Control group: intravenous morphine 0.1 Mg/Kg ( Darupakhsh pharmaceutical co. Iran) will be administrated. Four puffs of intranasal saline spay will be used as placebo.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Mahboub Pouraghaei
Street address
Emergency Medicine Department, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2078
Email
tbzemrt2014@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Abolghasem jouyban
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
Province
East Azarbaijan
Postal code
5166614776
Phone
+98 41 3335 7313
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahboub Pouraghaei
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Emergency Medicine Department, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2078
Email
pouraghaeim@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahboub Pouraghaei
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Emergency Medicine Department, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2078
Email
pouraghaeim@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahboub Pouraghaei
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Emergency Medicine Department, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2078
Email
pouraghaeim@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All collected de-identified IPD.
When the data will become available and for how long
Data will be available in September 2020.
To whom data/document is available
All interested researchers may have access to data.
Under which criteria data/document could be used
Data will be available for use in researches. researchers can ask for data by email and they will receive data in two weeks.
From where data/document is obtainable
pouraghaeim@tbzmed.ac.ir
What processes are involved for a request to access data/document
By sending email to pouraghaeim@tbzmed.ac.ir they can receive data in two weeks