study of the analgesic effect of fentanyl, fentanyl with ibuprofen, fentanyl with apotel and fentanyl with ketorolac on the reduction of pain and duration of hospitalization in patients with renal colic
Comparison of analgesic effect of fentanyl alone with simultaneous administration of fentanyl with ibuprofen, apotel and ketorolac on pain reduction and duration of hospitalization of renal colic patients referred to emergency department of Ayatollah Kashani Hospital in Shahrekord
Design
The clinical trial with control groups, with parallel, double-blind, randomized, phase 2 groups on 200 patients
Settings and conduct
All patients referred to Kashani Hospital in Shahrekord with renal colic will be selected for a sample of 200 people and according to the randomly blocked allocation method, patients will be randomly assigned to 4 groups (F: fentanyl alone, FK: fentanyl and ketorolac, FA: Fentanyl and Apotel, FI: Fentanyl and ibuprofen) will be divided into a way that the researcher and patient are unaware of the type of intervention.
Participants/Inclusion and exclusion criteria
All patients over the age of 18 years and stable hemodynamics referred to Kashani Hospital in Shahrekord with renal colic in 2022-2023 will be the study population.
Intervention groups
Group F:Patients who receive fentanyl at a dose of 50 μg (Darou Pakhsh Company) in the form of intravenous infusion.
Group FK: Patients who receive fentanyl at a dose of 50 μg (Darou Pakhsh Company) in the form of intravenous infusion and ketorolac (Alborz Company) with a dose of 30 mg in rapid infusion within 15 seconds.
FA Group: Patients who receive fentanyl at a dose of 50 μg (Darou Pakhsh Company) and apotel (Elixir Company) with a dose of 1 gram per 100 cc normal saline within 20 minutes in the form of intravenous infusion.
FI Group: Patients who receive fentanyl at a dose of 50 μg (Darou Pakhsh Company) and ibuprofen (Caspian Company) in 300 mg intravenous infusion.
Main outcome variables
Blood pressure, heart rate, blood oxygen percentage, respiratory rate; ketorolac,fentanyl, apotel and ibuprofen side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220421054605N1
Registration date:2022-05-31, 1401/03/10
Registration timing:prospective
Last update:2022-05-31, 1401/03/10
Update count:0
Registration date
2022-05-31, 1401/03/10
Registrant information
Name
Fatemeh Zahedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 914 007 9760
Email address
zahedifatemeh744@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-10, 1401/03/20
Expected recruitment end date
2022-12-21, 1401/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
study of the analgesic effect of fentanyl, fentanyl with ibuprofen, fentanyl with apotel and fentanyl with ketorolac on the reduction of pain and duration of hospitalization in patients with renal colic
Public title
study of the analgesic effect of fentanyl, fentanyl with ibuprofen, fentanyl with apotel and fentanyl with ketorolac in patients with renal colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over the age of 18
have renal colic
have stable hemodynamics(pulse rate(PR)=60-100,systolic blood pressure(SBP)>100,respiratory rate(RR)=8-22,functional oxygen saturation(SPO2)>90%)
Have informed consent to participate in this study
Don't have any of the following: Pregnancy/Asthma / chronic obstructive pulmonary disease(COPD)/ Intestinal obstruction/ Hypertension and heart failure/ Previous pulmonary surgery of the kidney and urinary tract/ Peptic ulcer/ Gastrointestinal bleeding/ Previous allergies to fentanyl or other analgesics / Loss of consciousness/ Trauma Head and chest/pneumocephalus/pneumothorax/Drug addiction/tenderness and abdominal rebound/Guarding abdomen/menstruation retarded/Use of analgesics in the past 24 hours
No liver failure and bilateral renal failure
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 200 eligible patients will be randomly selected. Then random numbers are created by computer software "Random Allocation". These numbers are randomly divided into four groups A (first intervention) , B (second intervention) , C (Third intervention) and D ( fourth 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 four groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, fentanyl , ibuprofen , ketorolac and apotel, 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
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2022-01-09, 1400/10/19
Ethics committee reference number
IR.SKUMS.REC.1400.071
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, 10، 15، 20، 25 and 30 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, 10، 15، 20، 25 and 30 minutes after the intervention
Method of measurement
Monitoring device
2
Description
Hear rate
Timepoint
At the beginning of the study and at 5, 10، 15، 20، 25 and 30 minutes after the intervention
Method of measurement
Monitoring device
3
Description
Percentage of blood oxygen
Timepoint
At the beginning of the study and at 5, 10، 15، 20، 25 and 30 minutes after the intervention
Method of measurement
Monitoring device
Intervention groups
1
Description
Intervention group 1: In this group, fentanyl (Darou Pakhsh Company) with a dose of 50 μg is administered as intravenous infusion.
Category
Treatment - Drugs
2
Description
Intervention group 2: For patients in this group, fentanyl (Darou Pakhsh Company) at a dose of 50 μg and ketorolac (Alborz Company) at a dose of 30 mg is administered intravenously.
Category
Treatment - Drugs
3
Description
Intervention group 3: For patients in this group, fentanyl (Darou Pakhsh Company) with a dose of 50 μg and Apotel (Elixir Company) with a dose of 1 g/100 cc normal saline, will be administered in 20 minutes as intravenous infusion.
Category
Treatment - Drugs
4
Description
Intervention group 4: For patients in this group, fentanyl (Darou Pakhsh Company) with a dose of 50 mcg and ibuprofen (Caspian Company) is administered 300 mg in intravenous infusion.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Kashani Hospital
Full name of responsible person
Abdul Rahim Sane'i Dehkordy
Street address
Shahrekord University of Medical Sciences, Kashani street,
City
Sharekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
sanei.a@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Esfandiar Heidari
Street address
Vice Chancellory for research, Shahrekord University Of Medical Sciences, Kashani Blvd
City
Sharekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 2414
Email
zahedifatemeh744@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Abdul Rahim Sane'i Dehkordy
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Shahrekord University of Medical Sciences, Kashani street,
City
Shahre-kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
zahedifatemeh744@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Abdul Rahim Sane'i Dehkordy
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Shahrekord University of Medical Sciences, Kashani street,
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
sanei.a@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Abdul Rahim Sane'i Dehkordy
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Shahrekord University of Medical Sciences, Kashani street,
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
zahedifatemeh744@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
No - There is not 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