Comparison between the effect of pethidine, ketorolac and ketorolac-diazepam combination in reducing pain in patients with acute low back pain referred to the emergency department
Comparison between pethidine, ketorolac and ketorolac-diazepam combination in reducing pain in patients with low back pain referred to Peymaniyeh hospital emergency department.
Design
The present study is a clinical trial with parallel, double-blind and randomized groups. The study population consisted of 90 patients admitted to the emergency room because of back pain patient is Peymanieh. Dice were used for randomization.
Settings and conduct
Written consent was obtained from all individuals and this study was approved by the Ethics Committee. In this double-blind randomized clinical trial, 90 patients who referred to the emergency department of Peymanieh Hospital in Jahrom due to acute low back pain were included in the study. Sampling was easy and patients were randomly divided into 3 groups of 30 by throwing dice.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients with acute lumbar pain referred to the emergency department of Peymanieh Hospital in Jahrom in 2020. No entry conditions: Patients over 80 years of age and lack of conscious consent to participate in the study
Intervention groups
The first group is patients who received 50 mg of pethidine (IV), the second group received 30 mg of ketorolac (ampoule) and 10 mg of diazepam intravenously, and the third group received ketorolac alone 30 mg of ketorolac (ampoule).
Main outcome variables
In this study, pain was the main outcome.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201003048903N1
Registration date:2020-10-21, 1399/07/30
Registration timing:retrospective
Last update:2020-10-21, 1399/07/30
Update count:0
Registration date
2020-10-21, 1399/07/30
Registrant information
Name
Esmaeal Rayat Dost
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5433 6085
Email address
e.rayat.dost@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-25, 1398/08/03
Expected recruitment end date
2020-06-25, 1399/04/05
Actual recruitment start date
2019-11-27, 1398/09/06
Actual recruitment end date
2020-06-30, 1399/04/10
Trial completion date
2020-10-27, 1399/08/06
Scientific title
Comparison between the effect of pethidine, ketorolac and ketorolac-diazepam combination in reducing pain in patients with acute low back pain referred to the emergency department
Public title
The effect of pethidine, ketrolac and the combination of ketorolac and diazepam on low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who refer to the emergency department of Peymanieh Hospital in Jahrom due to acute low back pain in 2019-2020.
Informed consent to attend the study
Exclusion criteria:
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
In our study, patients were divided into 3 equal groups by block randomization. The randomization method was that for each group, 15 numbers in one envelope for men and 15 numbers in other envelopes for women were sampled by the nurse in charge (a total of 30 envelopes for each group). The nurse in charge of sampling for randomly referred patients once removed a number from a group of men and once a bag of women, respectively, and delivered it to the patient, to be delivered to the doctor by the time of referral. For the next group, the same thing was done consecutively with the first group, and for the third group, the same thing was repeated. The nurse wrote down in a notebook which group the person referred to the doctor belonged to and wrote it down. But neither the doctor nor the patient himself knew in which study group the patient was placed.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, physicians and nurses in the emergency department of Peymaniyeh Hospital, as well as those responsible for data collection, were blinded like patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Jahrom University of Medical Sciences
Street address
Jahrom University of Medical Sciences Campus Building ,Ostad Motahhari Blvd, after the School of Nursing and Midwifery, Jahrom City, Iran
City
Jahrom
Province
Fars
Postal code
7414846199
Approval date
2019-01-30, 1397/11/10
Ethics committee reference number
IR.JUMS.REC.1397.150
Health conditions studied
1
Description of health condition studied
low back pain
ICD-10 code
G89.29
ICD-10 code description
Other chronic pain
Primary outcomes
1
Description
Pain
Timepoint
In this study, the effect of pethidine, ketrolac and ketrolac-diazepam combination on patients' pain was measured in the time periods before injection, immediately after injection, 5, 10, 20, 60 and 90 minutes after injection.
Method of measurement
Pain variable was measured in this study using Visual Analogue Scale.
2
Description
blood pressure
Timepoint
In this study, the effect of pethidine, ketrolac and ketrolac-diazepam combination on patients' blood pressure was measured in the time periods before injection, immediately after injection, 5, 10, 20, 60 and 90 minutes after injection.
Method of measurement
In this study, blood pressure was measured using a manual blood pressure monitor and a cuff monitoring device.
3
Description
Heart rate per minute
Timepoint
In this study, the effect of pethidine, ketrolac and ketrolac-diazepam combination on patients' heart rate was measured at the time before injection, immediately after injection, 5, 10, 20, 60 and 90 minutes after injection.
Method of measurement
The heart rate of patients in this study was measured by a nurse in the emergency department and a monitor installed in the emergency department.
4
Description
The amount of oxygen saturation in the blood
Timepoint
In this study, the effect of pethidine, ketrolac and ketrolac-diazepam combination on patients' blood oxygen saturation was measured at the time before injection, immediately after injection, 5, 10, 20, 60 and 90 minutes after injection. .
Method of measurement
Patients' blood oxygen levels were measured using a monitor installed in the emergency department.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first group consisted of 30 patients with low back pain who received 50 mg of pethidine (intravenously).
Category
Treatment - Drugs
2
Description
Intervention group: The second group consisted of 30 patients with low back pain who received 30 mg of ketorolac (ampoule) and 10 mg of diazepam intravenously.
Category
Treatment - Drugs
3
Description
Intervention group: The third group consisted of 30 patients with low back pain who received 30 mg of ketrolac alone (ampoule) intravenously.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emergency department of Peymaniyeh Hospital in Jahrom
Full name of responsible person
Dr Esmaeal Rayat Dost
Street address
Jahrom University of Medical Sciences Campus Building ,Ostad Motahhari Blvd, after the School of Nursing and Midwifery, Jahrom City, Iran
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5433 6085
Email
e.rayat.dost@jums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Dr Kavous Solhjoo
Street address
Jahrom University of Medical Sciences Campus Building ,Ostad Motahhari Blvd, after the School of Nursing and Midwifery, Jahrom City, Iran
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5433 6085
Email
e.rayat.dost@jums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahrom 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
Jahrom University of Medical Sciences
Full name of responsible person
Esmaeal Rayat Dost
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Motehari street
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5433 6085
Fax
Email
e.rayat.dost@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Esmaeal Rayat Dost
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Motehari street
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5433 6085
Fax
Email
e.rayat.dost@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Esmaeal Rayat Dost
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Motehari street
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5433 6085
Fax
Email
e.rayat.dost@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
Undecided - It is not yet known if there will be 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
Patients 'personal data, including patients' first and last names, will not be disclosed in accordance with ethical obligations. Data on the main outcomes of the study will be published.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Post-publication study data is available to all researchers.
Under which criteria data/document could be used
The data can be used with the permission of the researcher and therapeutic uses.
From where data/document is obtainable
Research Council of Jahrom University of Medical Sciences
What processes are involved for a request to access data/document
Request for access to the data of the present study must be submitted in writing to the Committee and Research Council of Jahrom University of Medical Sciences and with ethical commitments.