Comparison of the effect of aminophylline and hyoscine with morphine on the reduction of renal colic pain caused by urinary stones.
Design
This randomized, double blind trial was conducted with two parallel intervention groups on 128 patients with renal colic pain in 1397. Patients were divided into two groups by throwing coins..
Settings and conduct
This double blind randomized trial was conducted to compare pain relief in patients with renal colic in the two groups of aminophylline-hyoscine and morphine in the Peymreani Hospital of Jahrom.In this study, the systolic, diastolic and mean arterial blood pressure of the patient, along with the pain intensity of the patient before and after injection of drugs and after injection, were measured. The participant in the study, and the person collecting the information and the investigator, were unaware.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients with renal colic pain who were between 18 and 55 years of age.
Exclusion criteria: Pregnancy؛ addiction ؛ history of high blood pressure؛ kidney surgery؛ Get pain medication before intervention.
Intervention groups
In intervention group one, we injected a 20 mg muscle hyosmoon with aminophylline at a dose of 250 mg / 10 ml in normal saline, and in the second intervention group we injected 0.1 mg / kg of morphine intravenously.
Main outcome variables
Intensity of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180805040712N1
Registration date:2019-03-04, 1397/12/13
Registration timing:retrospective
Last update:2019-03-04, 1397/12/13
Update count:0
Registration date
2019-03-04, 1397/12/13
Registrant information
Name
Mohammad safaei saruei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3620 9889
Email address
m.safaie@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-07, 1397/01/18
Expected recruitment end date
2018-04-14, 1397/01/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of pain relief between aminophylline and hyoscine with morphine in patients with renal colic.
Public title
Comparison of pain relief between aminophylline and hyoscine with morphine in renal colic.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with renal colic pain caused by urinary stones
People between 18 and 55 years old
Exclusion criteria:
Pregnancy
Addiction
History of high blood pressure
The history of kidney surgery
Get pain medication before intervention
Age
From 18 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
128
Actual sample size reached:
128
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients were divided into two groups by throwing coins. The first group received 20 mg muscle hyoscine plus 3 to 6 mg / kg of aminophylline in normal saline. The second group received 0.1 mg / kg of morphine intravenously.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the present study, the patients in the study, the researcher and the person collecting data about who were in the group were unaware.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Jahrom University of Medical Science
Street address
Pardis Building, Motahari Blvd. ,Jahrom
City
Jahrom
Province
Fars
Postal code
74148-46199
Approval date
2017-09-19, 1396/06/28
Ethics committee reference number
IR.JUMS.REC.1396.054
Health conditions studied
1
Description of health condition studied
Renal colic pain caused by urinary stones.
ICD-10 code
N20.9
ICD-10 code description
Urinary calculus, unspecified
Primary outcomes
1
Description
Intensity of pain
Timepoint
Before the intervention and 5, 10, 15 and 30 minutes after the administration of the medication
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: received 20mg muscle hyoscine with aminophylline at a dose of 250mg / 10ml in normal saline.
Category
Treatment - Drugs
2
Description
Intervention group2: Morphine was given as an intravenous dose of 0.1mg / kg.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Peymaniye hostpital
Full name of responsible person
Mohammad Safaei Sarouei
Street address
Peymaniye Hostpital,Valiye Asr St, Jahrom City, Fars Province
City
Jahrom
Province
Fars
Postal code
74148-46199
Phone
+98 71 5434 0409
Email
m.safaie@jums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Kavoos solhjoo
Street address
Pardis Building, Motahari Blvd. ,Jahrom
City
Jahrom
Province
Fars
Postal code
74148-46199
Phone
+98 71 5434 0409
Email
m.safaie@jums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahrom 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
Jahrom University of Medical Sciences
Full name of responsible person
Mohammad Safaei Sarouei
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Urology
Street address
Pardis Building, Motahari Blvd. ,Jahrom
City
Jahrom
Province
Fars
Postal code
74148-46199
Phone
+98 71 5434 0409
Email
m.safaie@jums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Esmaile raiyat dust
Position
Emergency Medicine Specialist
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Pardis Building, Motahari Blvd. ,Jahrom
City
Jahrom
Province
Fars
Postal code
74148-46199
Phone
+98 71 5423 0085
Fax
Email
m.safaie@jums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Mohammad Safaei saruei
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Urology
Street address
Pardis Building, Motahari Blvd. ,Jahrom
City
Jahrom
Province
Fars
Postal code
74148-46199
Phone
+98 71 3620 9889
Fax
Email
m.safaie@jums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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