Comparative survey of nebulized morphine and intravenous morphine for decreasing renal colic patients' pain.
Design
In this research, 50 patients with renal colic devided in two groups randomly. Emergency department nurse starts the treatment with IV and nebouized morphine .
Settings and conduct
Location:Shahid Sadoughi Hospital and Shahid Rahnemoun Hospital in Yazd.
The patient, the nurse,the researcher,the result evaluator , data analyzer , aren't aware of treatment method.
Participants/Inclusion and exclusion criteria
All patient above 18 years old with renal colic who has severe pain that are confirmed by urine analysis or ultrasonography.
exclusion criteria : Morphine sensitivity ,systole blood pressure<110 millimeter mercury – respiratory rate<12 per minute - saturation of oxygen<95 percent , rhinitis or nose blocking , using pain-killer in 6 hours before visit and people with asthma and morphine sensitivity don't get surveyed.
Intervention groups
In first group : 5 mg morphine iv + 5 cc n/s nebulize (placebo) and in second group 10 mg morphine nebulize + 5 cc n/s iv treated.
Main outcome variables
pain level , side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171226038089N1
Registration date:2018-02-18, 1396/11/29
Registration timing:retrospective
Last update:2018-02-18, 1396/11/29
Update count:0
Registration date
2018-02-18, 1396/11/29
Registrant information
Name
Ali Saadat Yar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3821 5128
Email address
alisaadatyar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-04-30, 1396/02/10
Actual recruitment start date
2016-12-21, 1395/10/01
Actual recruitment end date
2017-04-30, 1396/02/10
Trial completion date
empty
Scientific title
Comparative survey of nebulized morphine and intravenous morphine for decreasing renal colic patients' pain
Public title
Comparative survey of nebulized morphine and intravenous morphine in renal colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patient above 18 years old
severe pain caused by renal colic assigned by U/A
severe pain caused by US
Exclusion criteria:
Morphine sensitivity
SO2<95
RR<12
SBP<110
rhinitis
nose blocking
asthma
gainig analgesic 6 hours before admit
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
46
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Convenience sampling by filling up the questionnaire achieves to finish the process.Randomization is individual and Emergency department nurse, enters the samples to each therapy processes.
Blinding (investigator's opinion)
Double blinded
Blinding description
When a case enters, the nurse allocates the patient into case and control groups using a coin. He/She treats case or control. Then another nurse fills up the questionnaire . At the end the outcome assessor classified the questionnaire.
Placebo
Used
Assignment
Parallel
Other design features
"VAS" is used for pain measurement.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Sciences
Street address
Shahid Sadoughi Uni , Bahonar Sq
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2016-08-05, 1395/05/15
Ethics committee reference number
IR.SSU.MEDICINE.REC.1395.182
Health conditions studied
1
Description of health condition studied
Renal colic
ICD-10 code
N23
ICD-10 code description
Unspecified renal colic
Primary outcomes
1
Description
Pain caused by renal colic
Timepoint
0-10-20-30 minutes after starting remedy
Method of measurement
using Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
intervention group:10 mg morphine nebulize and 5cc normal saline iv
Category
Treatment - Drugs
2
Description
Control group: 5 mg morphine iv and 5cc normal saline nebulize
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoghi & Rahnemoun Hospital
Full name of responsible person
Ali Saadatyar
Street address
ُShahid Rahnemoun hospital , Farrokhi St
City
Yazd
Province
Yazd
Postal code
8913893111
Phone
+98 35 3626 0000
Fax
+98 35 3626 8070
Email
Rahnemoonhospital@ssu.ac.ir
Web page address
http://ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hooshang Mehrparvar
Street address
Shahid Sadoughi university , Bahonar St
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Fax
+98 35 3725 4750
Email
medschool@ssu.ac.ir
Web page address
http://ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Ali Saadatyar
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Yas 3 alley , Felestin Bld , Yazd
City
Yazd
Province
Yazd
Postal code
8915167549
Phone
+98 35 3821 5128
Email
alisaadatyar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mehrnaz Nikouiie
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Shahid Rahnemoun Hospital,Farrokhi St
City
Yazd
Province
Yazd
Postal code
8913893111
Phone
+98 35 3626 0000
Fax
+98 35 3626 8070
Email
mehrnaznikouyeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Ali Saadatyar
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Yas 3 alley , Felestin Bld
City
Yazd
Province
Yazd
Postal code
8915167549
Phone
+98 35 3821 5128
Email
alisaadatyar@gmail.com
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All of information is sharable
When the data will become available and for how long
beginning access from 2018
To whom data/document is available
university researcher
Under which criteria data/document could be used
I havn't think about it yet.
From where data/document is obtainable
Myself.mobile number:+989133560517
What processes are involved for a request to access data/document
Shahid Sadoughi university,uni research assistant-medicine school research assistant,emergency medicine group research assistant , DrNikouie ,Dr Saadat Yar