Rapid reduction and relief of pain is one of the primary goals of patients referred to the emergency department of medical centers. The use of rapid-acting drugs that are associated with the least complication and patient satisfaction, which leads to reducing the length of hospital stay in the emergency room and determining their duties.
Design
Clinical trial with 3 groups, parallel, the first group of 42 people receiving ketrolac, the second group of 42 people receiving morphine, the third group of 42 people receiving ketamine.
Settings and conduct
a) Admission of patients with initial diagnosis of renal colic to the emergency room of Shahid Madani Hospital in Karaj with inclusion criteria
b) 126 patients are randomly divided into 3 groups of 42 (first group: ketamine recipient, second group: ketrolac, third group: intravenous morphine) according to the statistical consultant.
c) Before taking the drug, a person will assess the severity of the initial pain using the Numerical Rating Scale (NRS).
d) Then the medicine will be prescribed according to the group in which the person is placed (Randomize). (Ketamine group ...)
Participants/Inclusion and exclusion criteria
Inclusion criteria: all patients with renal click pain.
Exclusion criteria: opium use in the last 6 hours; history of bipolar and psychological disease.
Intervention groups
From patients who refer to the emergency department of "Karaj Madani" Hospital with renal colic and have the necessary criteria to enter the study, 126 people are selected and randomly divided into 3 groups of 42 people.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211023052851N1
Registration date:2021-12-19, 1400/09/28
Registration timing:retrospective
Last update:2021-12-19, 1400/09/28
Update count:0
Registration date
2021-12-19, 1400/09/28
Registrant information
Name
Fereshte Lotfi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8833 1084
Email address
l32fereshteh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-08, 1400/08/17
Expected recruitment end date
2021-11-21, 1400/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision of the efficacy of IV ketamine with IV morphine and IV ketorolac in patients with renal colic
Public title
The effect of ketamine in improving renal colic pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with renal colic pain
Exclusion criteria:
Taking opium drugs in past 6 hours
History of bipolar and psychological disease
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient will only be told that we will prescribe painkillers, but only the participant will be unaware of the medication received.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Science
Street address
Office of the Ethics Committee-Second Floor-Deputy of Research and Technology-Saffarian Alley-45 meters from Golshahr
City
Karaj
Province
Alborz
Postal code
1411953473
Approval date
2021-03-06, 1399/12/16
Ethics committee reference number
IR.ABZUMS.REC.1400.039
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
The rate of patient pain reduction
Timepoint
Will assess the severity of pain and side effects at 5, 15, 30 and 60 minutes after drug administration
Method of measurement
The patient is asked to give a score of 10 for the most severe pain he or she has ever experienced, and to rate his or her current pain accordingly.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with renal colic pain who received intravenous ketamine. In this group of patients, 10% ketamine is slowly injected intravenously and the dosage is equivalent to 0.5 mg / kg body weight. This injection is given only once and its therapeutic effects are evaluated 6 hours after the injection. this drug is made by ROTEXMEDICA Pharmaceutical company.
Category
Treatment - Drugs
2
Description
Control group: Patients with renal colic who received intravenous morphine. Patients in this group receive 3 mg of diluted 1% morphine intravenously and slowly. This injection is given only once and the results are evaluated up to 6 hours after the injection. this drug is made by ROTEXMEDICA Pharmaceutical company.
Category
Treatment - Drugs
3
Description
Control group: Patients with renal colic pain who received intravenous ketorolac. In this group of patients, one 30 mg Ketrolac ampule, equivalent to one ml is injected intravenously. This injection is given only once and Results are evaluated 2 hours after injection. This drug is produced by Raha Pharmaceutical Company.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani Hospital
Full name of responsible person
Fereshteh Lotfi
Street address
Jahanshar blvd, karaj,alborz
City
Karaj
Province
Alborz
Postal code
1411953473
Phone
+98 21 8833 1084
Email
l32fereshteh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr mohammad reza maghsoodi
Street address
Deputy of Research and Technology-Saffarian Alley-45 meters from Golshahr
City
Karaj
Province
Alborz
Postal code
1411953473
Phone
+98 21 8833 1084
Email
dr.maghsoudi.m@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of Research of Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Mohamad Reza Maghsoodi
Position
Emergency medicine specialist
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Madani hospital, Jahanshahr blvd.
City
Karaj
Province
Alborz
Postal code
1411953473
Phone
+98 21 8833 1084
Email
dr.maghsoudi.m@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mohamad Reza Maghsoodi
Position
Emergency medicine specialist
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Madani hospital, Jahanshahr blvd.
City
Karaj
Province
Alborz
Postal code
1411953473
Phone
+98 21 8833 1084
Email
dr.maghsoudi.m@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Fereshte Lotfi
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Alborz School of Medicine, Campus of the University of Medical Sciences, Above the University of Arts, West Buali, Nabovat Square, Karaj
City
Tehran
Province
Tehran
Postal code
3149969415
Phone
+98 21 8833 1084
Fax
Email
l32fereshteh@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
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
Data on pain in renal colic patients after ketamine administration after patients were not identified
Data on pain in renal colic patients after morphine administration after patients were not identified
Data on pain in renal colic patients after administration of ketrolac after patients are not identified
When the data will become available and for how long
Access to data 6 months after the publication of the article
To whom data/document is available
Researchers workers in medical academic institutions
Under which criteria data/document could be used
Allow access to compare with other painkillers as well as scale with pain relief in other diseases
From where data/document is obtainable
to this email adress:
l32fereshteh@gmail.com
What processes are involved for a request to access data/document
The data will be reviewed and submitted within one business week upon request