A comparative study on the effect of Ketorolac and Hyosine on patients pain controlled with renal colic complications
Design
This is a parallel randomized clinical trial that will perform on 186 patients with renal colic. Randomization will perform with permuted blocked randomization using SPSS syntax. The block size will be 4. This study will enroll for 4 months.
Settings and conduct
This study will conduct as a clinical trial study with 186 patients who will refer to Imam Hossain Hospital of Shahroud. Patients must sign an informed consent form before entering the study. In this study; clinical caregiver and the analyzer will blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 16 and 75 years of patients; stable vital signs, definitive diagnosis of renal colic (with or without urinary tract stones in sonography); no underlying urinary tract disorders; no use of analgesic in 24 hours before referral and satisfaction with research participation.
Exclusion criteria: history of allergy to ketorolac and hyosine; unstable hemodynamics of patients; evidence of acute abdominal problems (tenderness, garding, rebind and rebind tenderness); pregnancy, Breastfeeding; known renal failure; known liver failure; a history of active gastric or peptic ulcer disease or gastrointestinal bleeding; addiction to a variety of opium and dissatisfaction with the plan.
Intervention groups
Patients entered into the study are divided into intervention and control groups. In the intervention group, treatment with ketorolac ampule will be prescribed. In the control group, treatment with hyocine ampule will be prescribed.
Main outcome variables
Reducing the severity of kidney pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100102002954N19
Registration date:2020-07-01, 1399/04/11
Registration timing:prospective
Last update:2020-07-01, 1399/04/11
Update count:0
Registration date
2020-07-01, 1399/04/11
Registrant information
Name
Mohammad Bagher Sohrabi
Name of organization / entity
Shahroud University of Medical Ssciences and Health
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
mb.sohrabi@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-21, 1399/04/31
Expected recruitment end date
2020-10-20, 1399/07/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on the effect of Ketorolac and Hyosine on patients pain controlled with renal colic complications, a randomized control trial
Public title
Comparison of the effect of ketorolac and hyosine on pain control in patients with renal colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 16 and 75 years of patients;
Stable vital signs;
Definitive diagnosis of renal colic (with or without urinary tract stones in sonography );
Absence of underlying urinary tract disorders;
Do not use any analgesic for 24 hours before visiting;
Satisfaction of research participation.
Exclusion criteria:
Unstable hemodynamics of patients;
History of allergy to ketorolac and hyosine;
Evidence of Acute Abdominal Problems (tenderness, guarding, rebind, and rebind tenderness);
Pregnancy;
Breastfeeding;
Renal failure is known;
Liver failure is known;
A history of active gastric ulcer disease or gastrointestinal bleeding;
Addiction to a variety of opium;
Dissatisfaction with participating in the project.
Age
From 16 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
186
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done using permuted block randomization method using blocked random allocation syntax in SPSS software. For calculation sample size, number of blocks and block size was determined. Block size was 4. Allocation concealment was done using closed opaque envelope.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences; 7 Tir squer, Shahroud
City
Shahroud
Province
Semnan
Postal code
3616647555
Approval date
2018-10-12, 1397/07/20
Ethics committee reference number
IR.SHMU.REC.1397.141
Health conditions studied
1
Description of health condition studied
Renal colic
ICD-10 code
MF56
ICD-10 code description
A severe paroxysmal pain in the flank radiating to the groin, scrotum or labia, caused by blockage of the renal pelvis or ureter most commonly by a renal stone. May be associated with nausea and vomiting.
Primary outcomes
1
Description
Reduce the severity of renal pain
Timepoint
Once every hour
Method of measurement
Ask the patient and use the visual analog score (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: for patients in this group, after administration of serum, 30 mg of ketorolac (one ampule) is given intramuscular, and if pain is not controlled within 2 hours, the same dose will be repeated.
Category
Treatment - Drugs
2
Description
Control group: For patients in this group after administration of serum, 20 mg of hyosine (one ampule) is administered intramuscular and if the pain is not controlled within 2 hours, the same dose will be repeated.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital of Shahroud
Full name of responsible person
Dr. Hossain Amiri Lorghani
Street address
Imam Hossein Hospital., End Imam street., Shahroud , Iran
City
Shahroud
Province
Semnan
Postal code
3616611151
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
h_amiri@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hasan Emamian
Street address
Vice chancellor for research; Shahroud University medical Sciences ,7th Tir squar, Shahroud
City
Shahroud
Province
Semnan
Postal code
3616647555
Phone
+98 23 3239 4499
Fax
+98 23 3239 4800
Email
pajouhesh@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor for research; Shahroud University medical and 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
Shahroud University of Medical Sciences
Full name of responsible person
Sara kianmehr
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Imam Hossein Hospital, End Imam street, Shahroud, Iran.
City
Shahroud
Province
Semnan
Postal code
3616611151
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
sara_kianmehr@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Hossain Amiri Lorghani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
mam Hossein hospital., End Imam street., Shahroud., Iran
City
Shahroud
Province
Semnan
Postal code
3616611151
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
h_amiri@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr.Mohammad Bagher Sohrabi
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Imam Hossein Hospital, End Imam street, Shahroud, Iran
City
Shahroud
Province
Semnan
Postal code
3616611151
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
mb.sohrabi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available