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The effect of adding sublingual desmopressin to the intravenous treatment with Apotel and ketorolac in patients with mild to moderate renal colic pain

Protocol summary

Study aim
Determining the effect of adding sublingual desmopressin to intravenous treatment with Apotel and ketorolac in patients with mild to moderate renal colic pain. Using the results and information of this study to measure the effectiveness of desmopressin in controlling the pain of renal colic and reducing the amount of pain while having fewer and cheaper side effects is the availability of desmopressin.
Design
A controlled, parallel-group, unblinded, randomized, phase 3 clinical trial on 102 randomized sealed envelopes.
Settings and conduct
Clinical trial on the effect of desmopressin in renal colic, emergency department of Imam Khomeini hospital in Ahvaz and emergency department of Golestan hospital in Ahvaz, patients who have renal colic and meet the inclusion criteria are randomly selected into two intervention and control groups, and desmopressin intervention group It will be given
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients with renal colic who have not received painkillers in the last three hours and are not suffering from high blood pressure, coronary artery disease, gastric ulcer, kidney failure and liver failure and are not taking anticoagulant treatment and are not pregnant.
Intervention groups
In group A (control), apotel 1g and ketorolac 30mg are injected, and group B (intervention) apotel 1g and ketorolac 30mg are injected, and a sublingual tablet of desmopressin is placed under the patient's tongue.
Main outcome variables
Determining the amount of pain in control and intervention group at times zero, 15m , 30m , 45 m ,60m and comparing them comparison of pain reduction time in intervention and control group comparison the speed of pain reduction in intervention and control group Determining of complications in control and intervention group and comparing them

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230704058673N1
Registration date: 2023-08-19, 1402/05/28
Registration timing: registered_while_recruiting

Last update: 2023-08-19, 1402/05/28
Update count: 0
Registration date
2023-08-19, 1402/05/28
Registrant information
Name
mojtaba sasani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3392 4155
Email address
sasani-m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-21, 1402/04/30
Expected recruitment end date
2024-01-20, 1402/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adding sublingual desmopressin to the intravenous treatment with Apotel and ketorolac in patients with mild to moderate renal colic pain
Public title
The effect of desmopressin in reducing the pain of renal colic patientsSearch for this on Google
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with renal colic who have not received painkillers in the last three hours Do not have hypertension Do not have coronary artery disease Do not have gastric ulcers Do not have renal failure Do not have liver failure Do not pregnant Do not take anticoagulants
Exclusion criteria:
Patients who become unstable in terms of vital signs Have changes in blood pressure Tachycardia Headache dizziness seizure Occurrence of drug side effects Intolerance of pain during the study
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 102
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients are randomly assigned between groups A and B in a 1:1 ratio using sealed envelopes.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee in the research of Golestan Hospital
Street address
Goletan . farvardin bolvar . goletan hospital . emergency department
City
ahvaz
Province
Khouzestan
Postal code
6135733118
Approval date
2023-05-20, 1402/02/30
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1402.053

Health conditions studied

1

Description of health condition studied
The effect of adding sublingual desmopressin to the intravenous treatment with Apotel and ketorolac in patients with mild to moderate renal colic pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
intensity of pain
Timepoint
zero, 15 minutes, 30 minutes, 45 minutes, 60 minutes,
Method of measurement
Using the visual analog scale (VAS) for this purpose, the printed VAS ruler is shown to the patients and they are asked to indicate the number that represents their current pain.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Mojtaba Sasani
Street address
Goletan . farvardin bolvar . goletan hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3392 4155
Email
sasani-m@ajums.ac.ir

2

Recruitment center
Name of recruitment center
Imam Khomeini Hospital of Ahvaz
Full name of responsible person
Mojtaba Sasani
Street address
Twenty-four meter street. Imam Khomeini Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3222 2818
Email
sasani-m@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Ahmadi moghaddam
Street address
Golestan Ave,Jondishapur university
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mojtaba Sasani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Golestan Ave,Jondishapur University
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3571 5794
Email
Drsasani72363@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
مجتبی ساسانی
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Golestan Ave,Jondishapaur University
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 915 512 0247
Email
Drsasani72363@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mojtaba Sasani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Goletan . farvardin bolvar . goletan hospital . emergency department
City
اهواز
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3392 4155
Email
sasani-m@ajums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
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
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