Determining the effect of inhaled salbutamol on the pain intensity of patients referred to the emergency room of Imam Khomeini Hospital in Sari
Design
Clinical trial with control group, double blind and randomized on 100 patients. Randbit Win Excel software was used for randomization
Settings and conduct
Collecting information from emergency department patients of Imam Khomeini Hospital, Sari. Non-random sampling method. Not informing the nurse and the patient about the contents of the drugs and in a double-blind manner
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Pain intensity based on Visual Analog Scale (VAS) in the medium range
The patient's willingness to participate in the study and obtain informed consent
Presence of clinical symptoms of renal colic along with at least one of the three cases of hematuria in the complete urine analysis test, seeing stones in radiography or ultrasound of the urinary tract
Exclusion criteria:
The patient's unwillingness to continue participating in the study at any time
History of previous seizures
History of heart, liver and kidney disease (except kidney stones)
Drug addiction
History of frequent visits to the emergency department due to acute renal colic
pregnancy
Patients with fever
history of allergy to the drugs used in the present study (ketorolac and salbutamol)
Patients with unstable hemodynamic symptoms (systolic blood pressure less than 90 mm Hg)
Receiving pain medication 6 hours before going to the emergency department.
Intervention groups
Intervention group: treatment with injectable ketorolac and placebo spray and then pain intensity is evaluated
Control group: treatment with injectable ketorolac along with salbutamol nebulizer and then pain intensity is evaluated
Main outcome variables
Pain intensity; hemodynamic index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231205060266N1
Registration date:2024-04-18, 1403/01/30
Registration timing:registered_while_recruiting
Last update:2024-04-18, 1403/01/30
Update count:0
Registration date
2024-04-18, 1403/01/30
Registrant information
Name
Seyed Mohammad Hoseininezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 1701
Email address
mhoseininezhad@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-18, 1403/01/30
Expected recruitment end date
2024-06-19, 1403/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of inhaled salbutamol on the pain intensity of patients with problems caused by acute renal colic: A double-blind clinical trial study.
Public title
The effect of inhaled salbutamol on the pain intensity of patients with problems caused by acute renal colic: A double-blind clinical trial study.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pain intensity based on Visual Analog Scale (VAS) in the medium range
The patient's willingness to participate in the study and obtain informed consent
The presence of clinical symptoms of renal colic along with at least one of the three cases of hematuria in the complete urine analysis test, seeing stones in radiography or ultrasound of the urinary tract.
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
With the declaration of consent of the patients and if they have the conditions to enter the study, the samples are selected and entered in the order of the research and using the output of Randbit Win Excel software (this function is used to generate random numbers in the defined intervals and instead of table of random numbers is used) will be randomly placed in two intervention and control groups
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be double blind. Salbutamol spray is used by Cipla India. The placebo spray used in this study will be prepared in cooperation with the Faculty of Pharmacy of Mazandaran University of Medical Sciences. The sprays are camouflaged in advance by a suitable cover so that the nurse and the patient are not aware of its contents. Medicines are kept in separate boxes with numbers 1 and 2 and are randomly prescribed to patients. Finally, only the principal investigator of the study is aware of the contents of the boxes
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Imam Khomeini Educational and Medical Center, Razi Street
City
Sari
Province
Mazandaran
Postal code
4816633131
Approval date
2023-08-14, 1402/05/23
Ethics committee reference number
IR.MazUMS.IMAMHOSPITAL.REC.1402.063
Health conditions studied
1
Description of health condition studied
Acute renal colic
ICD-10 code
N23
ICD-10 code description
Unspecified renal colic
Primary outcomes
1
Description
Severity of patients' pain
Timepoint
Measurement of pain intensity before the intervention, and at intervals of 10, 20, 30, 45, 60 and 120 minutes after the intervention.
Method of measurement
Evaluation of pain intensity with Visual Analog Scale (VAS), evaluation of hemodynamic variables with monitoring device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: These patients will be treated with 30 mg ketorolac by injection along with salbutamol nebulizer 10 puffs every 20 minutes, up to one hour. After 10 ,20 ,30 ,45 ,60 ,120 minutes, the pain intensity of the patients is re-evaluated by Visual Analogue Scale (VAS)
Category
Treatment - Drugs
2
Description
Control group: These patients will be treated with 30 mg ketorolac by injection and placebo spray 10 puffs every 20 minutes to one hour. After 10, 20, 30, 45, 60 and 120 minutes, the pain intensity of the patients is evaluated again by visual analogue scale (VAS)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini educational and therapeutic center of Sari
Full name of responsible person
Seyyed Mohammad Hosseini Nejad
Street address
Razi Street
City
Sari
Province
Mazandaran
Postal code
۴۸۱۶۶۳۳۱۳۱
Phone
+98 11 3336 1700
Email
emamsari.hospital@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Pedram Ebrahimnejad
Street address
Moalem Square ,Research and Technology Deputy Building
City
sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3325 7230
Email
pebrahimnejad@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Seyyed Mohammad Hosseini Nejad
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Razi street
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3335 0670
Email
emamsari.hospital@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Seyyed Mohammad Hosseini Nejad
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Razi street
City
Sari
Province
Mazandaran
Postal code
۳۳۱۳۱ -۴۸۱۶۶
Phone
+98 11 3335 0670
Email
emamsari.hospital@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Seyyed Mohammad Hosseini Nejad
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Razi street
City
Sari
Province
Mazandaran
Postal code
۳۳۱۳۱ -۴۸۱۶۶
Phone
+98 11 3335 0670
Email
emamsari.hospital@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
There is no further information
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available