Protocol summary

Study aim
Determining the comparative effect of intranasal ketamine, intravenous morphine and intravenous ketorolac in reducing pain in patients with renal colic.
Design
A phase 4 randomized, double-blind, parallel-group, controlled clinical trial on 99 patients. The rand function of Excel was used for randomization.
Settings and conduct
9 patients with renal colic referred to Shohada Ashayer Hospital in Khorramabad who are randomly assigned to treatment with morphine sulfate, ketamine or ketorolac. Patients' pain intensity is evaluated at 15, 30, 45 and 60 minutes after drug administration. Patients, drug-injecting nurses, and pain-asking physician are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients referred to the emergency department of Shohada Ashayer Hospital from August 23 to September 22, 2023 who have the following conditions: 1. Patients over 18 years old 2. Having symptoms of renal colic: pain on one or both sides of the patient 3. Diagnosis of kidney stone in CT scan or sonography Exclusion criteria: 1. Pregnant women 2. Addiction to opioids 3. History of allergy to morphine, ketamine or ketorolac 4. Nasal obstruction 5. Systolic blood pressure higher than 180 or lower than 90 mmHg 6. Respiratory distress 7. Decreased level of consciousness 8. Patients who do not have the necessary cooperation 9. History of gastrointestinal bleeding 10. Asthma patients 11. Receiving medication in the past 48 hours
Intervention groups
For patients in group A, 1mg/kg of ketamine intranasally and 5cc of normal saline intravenously, for patients in group B, 0.1mg/kg of morphine sulfate intravenously and 5cc of normal saline intranasally, and for patients in group C, 60mg of ketorolac intravenously and 5cc of normal saline intranasally will be injected.
Main outcome variables
Pain intensity based on Visual Analogue Scale

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230718058838N1
Registration date: 2023-07-20, 1402/04/29
Registration timing: prospective

Last update: 2023-07-20, 1402/04/29
Update count: 0
Registration date
2023-07-20, 1402/04/29
Registrant information
Name
Seyed Mobin Nouredini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3335 1530
Email address
mobinnouredini@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Intranasal Ketamine, Intravenous Morphine Sulfate, and Intravenous Ketorolac in Reducing the Pain of the Renal Colic Patients
Public title
Comparison of the Effectiveness of Intranasal Ketamine, Intravenous Morphine Sulfate, and Intravenous Ketorolac in Reducing the Pain of the Renal Colic Patients in the Emergency Department of Shohadeye Ashayer Hospital of Khorramabad: A Randomized Controlled Trial
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
More than 18 years old Renal colic symptoms existence: unilateral or bilateral flank pain Sign of nephrolithiasis in CT scan or Ultrasound imaging
Exclusion criteria:
Pregnant female Opioid addiction Sensitivity to Morphine sulfate, Ketorolac or Ketamine Nasal obstruction Systolic blood pressure upper than 180mmHg or lesser than 90mmHg Respiratory distress Loss of conscious Patient with no enough cooperation Past medical history of GI bleeding Past medical history of Asthma Medication using during last 48hours
Age
From 18 years old
Gender
Both
Phase
4
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 99
Randomization (investigator's opinion)
Randomized
Randomization description
We will stratify the patient into three groups according to the severity of the pain (1 to 4, 5 to 7 & 8 to 10), then we will use block randomization in each of these groups for finding the members of each prescription group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients will be randomly divided into three groups. For patients in group A, 1mg/kg of ketamine intranasally and 5cc of normal saline intravenously will be prescribed, in patients in group B, 0.1mg/kg of morphine sulfate intravenously and 5cc of normal saline intranasally will be used, and in patients in group C, 60mg of ketorolac intravenously and 5cc of normal saline intranasally will be injected. In injecting these drugs, a group of nurses will prepare the prescribed drugs in 5cc syringes according to the pre-designed block randomization method, and if the drug fills less than the syringe volume, they will dilute it with distilled water to reach 5cc volume and without informing the contents, only by specifying the route of drug injection, they will provide it to another group of nurses who are responsible for injecting the drug. It should be noted that patients will not be informed of the type of drug prescribed. The pain level of patients before drug injection and at minutes 15, 30, 45 and 60 after drug administration will be evaluated based on the VAS scale, the responsibility of pain score assessment in all patients will be performed by an experienced specialist physician who is not aware of the type of drug prescribed in the patient and finally the difference between the VAS score before drug administration and the specified times after drug administration will be used as a criterion for evaluating the success of drugs in reducing pain.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Lorestan University of Medical Sciences
Street address
Moalem ave
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Approval date
2023-07-15, 1402/04/24
Ethics committee reference number
IR.LUMS.REC.1402.126

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 severity in the renal colic patients
Timepoint
Before drug injection and 15, 30, 45 & 60 minute after injection
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intranasal injection of 1mg/kg ketamine & 5cc intravenous normal saline
Category
Treatment - Drugs

2

Description
Control group: Intravenous injection of 0.1mg/kg ketamine & 5cc intranasal normal saline
Category
Treatment - Drugs

3

Description
Control group: Intravenous injection of 60mg ketorolac & 5cc intranasal normal saline
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohada ashayer hospital
Full name of responsible person
Hamzeh hasani
Street address
Enghelab Ave, Khorramabad
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3323 6401
Email
shohadahospital@lums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Bahram delfan
Street address
Moalem Ave, Khorramabad
City
khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3330 0661
Email
publicrelation@lums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad 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
Khoram-Abad University of Medical Sciences
Full name of responsible person
Seyed Mobin Nouredini
Position
دانشجو
Latest degree
A Level or less
Other areas of specialty/work
Medical Education
Street address
Keshavarzi Alley, Police Ave, Khorramabad
City
Khorramabad
Province
Lorestan
Postal code
6815833382
Phone
+98 66 3335 1530
Email
mobinnouredini@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Seyed Mobin Nouredini
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
Medical Education
Street address
Keshavarzi Alley, Police Ave, Khorramabad
City
Khorramabad
Province
Lorestan
Postal code
6815833382
Phone
+98 66 3335 1530
Email
mobinnouredini@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Seyed Mobin Nouredini
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
Medical Education
Street address
Keshavarzi Alley, Police Ave, Khorramabad
City
Khorramabad
Province
Lorestan
Postal code
6815833382
Phone
+98 66 3335 1530
Email
mobinnouredini@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
The whole data can be shared after making individuals unidentifiable.
When the data will become available and for how long
Access start 6 months after publication of results.
To whom data/document is available
Access is available for academic and scientific workers.
Under which criteria data/document could be used
Using the data is not allowed by others.
From where data/document is obtainable
Access to data is possible by sending an email to the research committee of Lorestan University of Medical Sciences.
What processes are involved for a request to access data/document
After sending an email to the research committee of Lorestan University of Medical Sciences via academic email, the relevant data will be sent to the applicant within a maximum of one week
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