Determining and comparing the effect of ketorolac and morphine on pain control in patients with renal colic
Design
A randomized, double-blinding clinical trial, with the parallel groups, Phase 2 on 272 patients
Settings and conduct
In this randomized double-blind clinical trial, 272 eligible patients referred to Ayatollah Kashani Hospital in Shahrekord will be included in the study and randomly divided into 2 groups. Patients will be injected with ketorolac in the first group and morphine in the second group. The intervention will be performed in such a way that the patient and the researcher will have no knowledge of the type of intervention and the double-blind conditions will be established. Then the patients' pain score and hemodynamic parameters will be evaluated and compared between the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria included age range of 16-65 years, the definitive diagnosis of renal colic, the pain intensity of equal to or more than 7, the non-drug addiction, the patients’ consent to participate in the study. Exclusion criteria included having a history of morphine or ketorolac allergy, pregnancy or suspected pregnancy, breastfeeding, having a history of taking painkillers over the last 4 hours.
Intervention groups
Intervention group 1: For patients in this group, intravenous morphine is prescribed at a dose of 1 mg / kg.
Intervention group 2: For patients in this group, intravenous ketorolac is prescribed at a dose of 30 mg.
A comparative study of the effect of intravenous ketorolac and morphine on pain control in patients with renal colic
Public title
Comparison of the effect of ketorolac and morphine on pain control in patients with renal colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age range of 16-65 years
The definitive diagnosis of renal colic (with renal colic symptoms and the presence of stones confirmed by CT)
The weight of 50-100 kg (for the effectiveness of the dose of 30 mg ketorolac)
The pain intensity of equal to or more than 7
The non-drug addiction
The patients’ consent to participate in the study
Exclusion criteria:
Having a history of morphine or ketorolac allergy
Pregnancy or suspected pregnancy
Breastfeeding
Having history of taking painkillers over the last 4 hours
Having a history of underlying diseases
Having traumatic eye or head injuries
Having one kidney or a kidney transplant
Having cerebral hemorrhage or the possibility of its occurrence
Having mental disorders
Having fibromyalgia
Having vascular and brain lesions
Having coagulation disorders, using angiotensin-converting enzyme (ACE) inhibitor or anticoagulants
Age
From 16 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
272
Actual sample size reached:
272
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 272 eligible patients will be randomly selected. Then random numbers are created by computer software "Random Allocation". These numbers are randomly divided into two groups A (first intervention) and B (second intervention). Each number is written on paper and placed in an envelope. Then each patient is asked to choose an envelope from among the envelopes. According to the selected envelope, the patient will be assigned to one of the two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, ketorolac and morphine, will be prepared by an emergency medicine specialist and placed in coded packages and delivered daily to the researcher, who will prescribe them without knowing the type of each drug. They do. Also, the person recording the clinical and basic information of the patients as well as the statistical analyst will not be aware of the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahre-Kord University of Medical Sciences
Street address
Shahrekord University Of Medical Sciences, Kashani Blvd
City
Shahrekord
Province
Isfehan
Postal code
8815713471
Approval date
2019-09-22, 1398/06/31
Ethics committee reference number
IR.SKUMS.REC.1398.143
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 score
Timepoint
At the beginning of the study and at 5, 15, 30, 60 and 90 minutes after the intervention
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
1
Description
Mean Arterial Pressure
Timepoint
At the beginning of the study and at 5, 15, 30, 60 and 90 minutes after the intervention
Method of measurement
Monitoring device
2
Description
Hear rate
Timepoint
At the beginning of the study and at 5, 15, 30, 60 and 90 minutes after the intervention
Method of measurement
Monitoring device
Intervention groups
1
Description
First intervention group: For patients in this group, morphine (Iran Darou Pharmaceutical Company) is administered intravenously at a dose of 1 mg/kg.
Category
Treatment - Drugs
2
Description
Second intervention group: For patients in this group, Ketorolac (Iran Darou Pharmaceutical Company) is administered intravenously at a dose of 30 mg.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Kashani Hospital
Full name of responsible person
Seyed Mehdi Pourafzali
Street address
Shahrekord University of Medical Sciences, Kashani street,
City
Sharekord
Province
Isfehan
Postal code
8815713471
Phone
+98 38 3333 0061
Fax
Email
res.med@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mohammad Karami
Street address
Vice Chancellory for research, Shahrekord University Of Medical Sciences, Kashani Blvd
City
Shahrekord
Province
Isfehan
Postal code
8815713471
Phone
+98 38 3334 2414
Fax
Email
vcrt@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahrekord 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
Esfahan University of Medical Sciences
Full name of responsible person
Seyed Mehdi Pourafzali
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Shahrekord University of Medical Sciences, Kashani street
City
Isfahan
Province
Isfehan
Postal code
8815713471
Phone
+98 38 3333 0061
Email
e.poursadra@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Seyed Mehdi Pourafzali
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Shahrekord University of Medical Sciences, Kashani street
City
Isfahan
Province
Isfehan
Postal code
8815713471
Phone
+98 38 3333 0061
Email
e.poursadra@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Seyed Mehdi Pourafzali
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Shahrekord University of Medical Sciences, Kashani street
City
Isfahan
Province
Isfehan
Postal code
8815713471
Phone
+98 38 3333 0061
Email
e.poursadra@gmail.com
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