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Comparative study of the effect of morphine and morphine plus Apotel on pain relief, hemodynamic status and drug side effects In patients with acute myocardial infarction

Protocol summary

Study aim
Comparative study of the effect of morphine and morphine plus Apotel on pain relief, hemodynamic status and drug side effects In patients with acute myocardial infarction
Design
Clinical trial with control group, with parallel groups, randomized, phase 2-3 on 60 patients. Excel software rand function was used for randomization
Settings and conduct
Sixty patients with acute myocardial infarction referred to the emergency department of Al-Zahra Hospital in Isfahan, who met the inclusion and exclusion criteria, were randomly assigned to morphine and apoptil with morphine in groups of 30 and after full explanation and informed written consent, in Upon admission to the emergency department, they underwent standard monitoring including electrocardiography (ECG), invasive blood pressure (IBP), heart rate (HR), and arterial blood oxygen percentage (SPO2). After drug injection, pain intensity, hemodynamic parameters and drug side effects were monitored.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients with chest pain and ECG changes indicating acute myocardial infarction or elevated ST segment, Age 20 to 80 years; Patient consent. Exclusion Criteria:Contraindications to taking Apotel and Morphine (severe diarrhea, pseudomembranous choline, acute respiratory failure, drug sensitivity, liver disease); Drug addiction
Intervention groups
Two treatment groups of 30 people including one group of morphine alone (control group) and one group of morphine with apotel were examined. In the first group (morphine alone) 5 mg of morphine in 10 minutes and in the second group (morphine-apotol) In addition to 5 mg of morphine, 1 g of apotel was infused over 30 minutes.
Main outcome variables
Pain intensity, systolic, diastolic blood pressure, mean arterial pressure, heart rate, blood oxygen saturation ,drug side effects

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220119053760N1
Registration date: 2022-02-13, 1400/11/24
Registration timing: retrospective

Last update: 2022-02-13, 1400/11/24
Update count: 0
Registration date
2022-02-13, 1400/11/24
Registrant information
Name
Neda Abrishami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3778 8089
Email address
n.abrishami@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-07-21, 1398/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of morphine and morphine plus Apotel on pain relief, hemodynamic status and drug side effects In patients with acute myocardial infarction
Public title
Effect of morphine and morphine plus apotel on pain status, hemodynamic parameters and drug side effects in patients with acute myocardial infarction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with chest pain and ECG changes indicating acute myocardial infarction or elevated ST segment, Age between 20 up to 80 years Patient consent
Exclusion criteria:
Contraindications to taking Apotel and Morphine (severe diarrhea, pseudomembranous choline, acute respiratory failure, drug sensitivity, liver disease) Drug addiction
Age
From 20 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Sixty patients with acute myocardial infarction were selected in easy manner at Al-Zahra Hospital in Isfahan and then, using Random Allocation software by simple random sampling method, patients were assigned to randomized groups of morphine and Apotel, respectively.
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 of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences , Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2018-07-11, 1397/04/20
Ethics committee reference number
1397.075.IR.MUI.MED.REC

Health conditions studied

1

Description of health condition studied
Acute myocardial infarction
ICD-10 code
I23.8
ICD-10 code description
Other current complications following acute myocardial infarction

Primary outcomes

1

Description
Intensity of pain
Timepoint
Times: zero (basal), 15 minutes later, 30 minutes later, 45 minutes later, 60 minutes after injection
Method of measurement
The Visual Analogue Scale (VAS) was reported from zero (painless) to ten (maximum pain experienced).

2

Description
blood pressure
Timepoint
Times: zero (basal), 15 minutes later, 30 minutes later, 45 minutes later, 60 minutes after injection
Method of measurement
Mercury blood pressure monitor in millimeters of mercury

3

Description
Heart rate
Timepoint
Times: zero (basal), 15 minutes later, 30 minutes later, 45 minutes later, 60 minutes after injection
Method of measurement
Tethoscope counts heart rate (in minutes)

4

Description
Blood oxygen saturation percentage
Timepoint
Times: zero (basal), 15 minutes later, 30 minutes later, 45 minutes later, 60 minutes after injection
Method of measurement
Pulse oximeter

5

Description
drug side effects
Timepoint
Times: 15 minutes later, 30 minutes later, 45 minutes later, 60 minutes after injection
Method of measurement
Observe the patient's condition and ask the patient

Secondary outcomes

empty

Intervention groups

1

Description
Control group: 5 mg of morphine (manufactured by Darupakhsh Pharmaceutical Company in 10 mg ampoules with a volume of 1 ml) was diluted in 10 cc of distilled water and identified and used as a morphine solution and infused over a period of ten minutes. .
Category
Treatment - Drugs

2

Description
Intervention group: 1 g of Apotel (manufactured by Elixir Pharmaceutical Company in 1 g ampoules in 6.7 ml) was dissolved in 100 cc of normal saline by an emergency nurse, as a solution of Apotel and 5 mg of morphine (manufactured by Darupakhsh Pharmaceutical Company in 10 mg ampoules with a volume of 1 ml) were diluted in 10 cc of distilled water and identified and used as a morphine solution. Then morphine solution was infused for 10 minutes and apotol solution for 30 minutes.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Al-Zahra Hospital
Full name of responsible person
Dr. Mehrdad Esmailian
Street address
Al-Zahra Hospital, Sofe Boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
n.abrishamy@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mansour Siavash Dastjerdi
Street address
Vice Chancellor for Research and Technology, Building No. 4, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 7898
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Dr. Mehrdad Esmailian
Position
Associate Professor of Emergency Medicine
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Department of Emergency Medicine, Isfahan School of Medicine (Al-Zahra Hospital), sohe Bl,.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
m_esmailian@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mehrdad Esmailian
Position
Associate Professor of Emergency Medicine
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Department of Emergency Medicine, Isfahan School of Medicine (Al-Zahra Hospital), sohe Bl,.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
m_esmailian@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Neda Abrishami
Position
Student
Latest degree
Master
Other areas of specialty/work
Biostatistics
Street address
Isfahan University of Medical Sciences, School of Medicine
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3778 8089
Fax
Email
n.abrishami@hlth.mui.ac.ir

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
Yes - There is 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
The data can be shared 6 months after the article is published and after identifying individuals.
When the data will become available and for how long
The data can be shared 6 months after the article is published and after identifying individuals.
To whom data/document is available
Doctors, specialists, nurses
Under which criteria data/document could be used
Comparison of new treatments
From where data/document is obtainable
Send email to n.abrishamy@gmail.com
What processes are involved for a request to access data/document
Send email to n.abrishamy@gmail.com
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