Comparing the efficacy of intradermal sterile water injection and intravenous morphine to control pain in patients with renal colic
Design
Two arm parallel group randomized trial and double blinded
Settings and conduct
The study done in Imam Khomein and Golestan hospital in ahvaz. Drugs were numbered and third person choose the program. The nurse who injected drugs, regarding the numeral of drugs, intervened. In sterile water group, intradermal sterile water and intravenous sterile water were received and in morphine group, intradermal normal saline and intravenous morphine injection received.
Participants/Inclusion and exclusion criteria
18 to 55 years old
Secondary education or more
History of nephrolithiasis which is documented in imaging study
VAS score is 5 or more
Volunteer Satisfaction
Contraindications of morphine administration
Pregnancy
Lactation
Trauma
Neuropathic pain in patients with lower back pain
Liver dysfunction
Renal dysfunction
History of cardiac arrhythmia
Peritonitis or pyelonephritis
GCS less than 15
Body weight more than 100 kilograms
Analgesic administration, before 6 hours presenting in Emergency Department
Drug addiction or receiving methadone
Do not satisfaction in project presentation
Intervention groups
Patients with renal colic pain who come to Imam khomeini and Golestan Hospital of ahvaz and injection of intradermal sterile water and intravenous morphine
Main outcome variables
pain in sterile water and morphine group
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181012041315N1
Registration date:2019-06-24, 1398/04/03
Registration timing:retrospective
Last update:2019-06-24, 1398/04/03
Update count:0
Registration date
2019-06-24, 1398/04/03
Registrant information
Name
Reza Mahjouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3843
Email address
mahjouri2003@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
2018-03-21, 1397/01/01
Actual recruitment end date
2019-03-20, 1397/12/29
Trial completion date
2019-03-20, 1397/12/29
Scientific title
Comparing the efficacy of intradermal sterile water injection and intravenous morphine to control pain in patients with renal colic
Public title
Comparing the efficacy of intradermal sterile water injection and intravenous morphine to control pain in patients with renal colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Secondary education or more
History of nephrolithiasis which is documented in imaging study with renal colic
VAS score is 5 or more
Volunteer Satisfaction
Exclusion criteria:
Contraindication of morphine administration
pregnancy
Lactation
Trauma
Neuropathic pain in lower back
Liver dysfunction
Renal dysfunction
History of cardiac arrhythmia
Peritonitis or pyelonephritis
GCS less than 15
Body weight more than 100 kilograms
Administration of analgesics, 6 hours before presenting in Emergency Department
Drug addiction or receiving Methadone
Do not satisfaction in project presence
Age
From 18 years old to 55 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
94
Actual sample size reached:
98
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with block sizes of 4
Blinding (investigator's opinion)
Double blinded
Blinding description
Patient and the nurse who injected drugs were blinded. Drugs were numbered and injected regarding the numbers which is mounted in the drugs
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Ahvaz university of Medical Sciences
Street address
golestan
City
ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2018-03-13, 1396/12/22
Ethics committee reference number
IR.AJUMS.REC.1396.1135
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
Timepoint
before, 15 and 30 and 45 and 60 minutes after injection of drug
Method of measurement
10 cm Visual Analog Scale score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 1: Sterile water group, 0.5 ml intradermal Sterile water in 49 patients in Sterile water group was injected, then 5 ml intravenous normal saline was injected, patients were observed one hour after injection.
Category
Treatment - Drugs
2
Description
Intervention group: 2: Morphine group,1 ml/kg intravenous morphine in 49 patients in morphine group was injected, then 0.5 ml intradermal normal saline was injected, patients were observed one hour after injection
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini and Golestan hospital of ahvaz
Full name of responsible person
Reza Mahjouri
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 11 3340 9544
Email
mahjouri2003@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr.Javad Mozaffari
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 11 3340 9544
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Reza Mahjouri
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 11 3340 9544
Email
mahjouri2003@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Reza Mahjouri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 11 3340 9544
Email
mahjouri2003@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Reza Mahjouri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 11 3340 9544
Email
mahjouri2003@yahoo.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
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
Total data will be shareable after unidentified.
When the data will become available and for how long
1399
To whom data/document is available
Researcher
Under which criteria data/document could be used
Traetment
From where data/document is obtainable
Dr. Javad Mozaffari
What processes are involved for a request to access data/document
Request from Emergency Department of Ahvaz university of medical scince