Comparing the analgesic effect of paracetamol and ketorolac with morphine in patients with kidney colic.
Design
Clinical trial consisting of the control group, with parallel groups, double blind-third phase with 30 patients. The block randomization is being used.
Settings and conduct
Emergency of Imam Reza hospital
Participants/Inclusion and exclusion criteria
Including criteria:
Age higher than 18 and lower than 65.
Pain in the flank both clinically or paraclinical.
NRS more than 3
Don't get pain killer for 6 hours.
GCS=15
Entering only once.
Excluding criteria:
Unknown kidney, liver, or heart failure
Sensitivity to opioids, paracetamol, or ketorolac
Pregnancy
Patients with transformed organ
Unstable vital signs; systolic blood pressure of lower than 90 mmHg
Signs of stimulation of peritoneum
Intervention groups
The first group (control group): Morphine was infused with the dose of 0.1 mg/kg intravenously (IV) with N/S 100 cc in 15 min.
The second group: Ketorolac was infused with the dose of 30 mg IV and paracetamol with the dose of 1000 mg with N/S 100 cc in 15 min.
Main outcome variables
Analgesic effect
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220108053669N1
Registration date:2022-01-16, 1400/10/26
Registration timing:prospective
Last update:2022-01-16, 1400/10/26
Update count:0
Registration date
2022-01-16, 1400/10/26
Registrant information
Name
Peyman Esmaeili Fard Barzegar
Name of organization / entity
Lorestan University
Country
Iran (Islamic Republic of)
Phone
+98 21 4411 3043
Email address
esmaeili.pe@fv.lu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the analgesic effect of paracetamol and ketorolac VS morphine in renal colic; A randomized controlled trial
Public title
Comparing the effect of the combination of two pain killers with morphine in patients with flank pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pain in flank clinically or paraclinically
NRS less than 3
Don't taking pain killer in 6 hours
GCS=15
Entering only for once
Exclusion criteria:
Unknown kidney, liver or heart failure
Sensitivity to opioids, paracetamol or ketorolac
Pregnancy
patients with transformed organs
Unstable vital signs; systolic blood pressure of lower than 90 mmHg
Sings of inflamed peritoneum
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The patients are grouped into two groups through block randomization. There are 4 blocks in which two special are for the sham group and two special blocks are for the control group and the numbers are determined randomly by computer.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drugs are prepared by the emergency staff who doesn't have any other impact on this study. The drugs are packed in similar packages in which they can only distinguish by numbers and they are administered by a nurse who doesn't know of the ingredients.
According to the patients' order and through the random block is administered by emergency nurses who are not aware of the component.
After administration, the intern will submit the amount of pain, in which they don't know the groups either, in 0, 15, and 30 minutes after administration by a numerical rating scale. If after 30 min the patients would have intolerable pain, by the doctor's permission, they will get a fentanyl dose.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Shahid Beheshti blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2021-12-19, 1400/09/28
Ethics committee reference number
IR.KUMS.REC.1400.634
Health conditions studied
1
Description of health condition studied
Pain in the flank - Kidney problem
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The amount of pain
Timepoint
15 minutes
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Vomiting
Timepoint
Every 15 minutes
Method of measurement
Questionnaire
2
Description
Vertigo
Timepoint
Every 15 minutes
Method of measurement
Questionnaire
3
Description
Hypotension
Timepoint
Every 15 minutes
Method of measurement
Measuring
Intervention groups
1
Description
Intervention group: Ketorolac and paracetamol with a dose of 30 mg IV and 1000 mg IV, respectively, is infused with 100 cc N/S in 15 min.
Category
Prevention
2
Description
Control group: Morphine with a dose of 0.1 mg/kg IV is infused with 100 cc N/S in 15 min.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Mohammad Reza Farnia
Street address
Shahid Beheshti blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6477
Email
mr.farnia@kums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammad Reza Farnia
Street address
Shahid Beheshti blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714869914
Phone
+98 83 3427 4618
Email
Mcollege@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammad Reza Farnia
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Shahid Beheshti blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714869914
Phone
+98 83 3427 4618
Email
mr.farnia@kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammad Reza Farnia
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Shahid Beheshti boulvard
City
Kermanshah
Province
Kermanshah
Postal code
6714869914
Phone
+98 83 3427 4618
Email
mr.farnia@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammad Reza Farnia
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Shahid Beheshti boulvard
City
Kermanshah
Province
Kermanshah
Postal code
6714869914
Phone
+98 83 3427 4618
Email
mr.farnia@kums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD