Protocol summary

Study aim
Investigation and comparison of the therapeutic effect of pantoprazole and injectable famotidine in patients with epigastric pain referred to the emergency department of Khatam al-Anbia (pbuh) Zahedan in 1401
Design
A three-blind clinical trial with a parallel, randomized group, data analysis and analysis with spss22.0 software
Settings and conduct
After the doctor confirms it as epigastric pain, the triage nurse gives a code to the patients according to the random table. And according to the previous announcement, the pharmacy colleague provides the medicine needed by the patient to his nurse based on the specific codes, and the nurses, without knowing the medicine, give the desired medicine a dose of 40 mg of pantoprazole or a dose of 40 mg of injectable famotidine diluted in 100 ml. Normal saline solution is prescribed as a rapid infusion for 2 to 4 minutes. Both drugs are the same in terms of color and appearance. In addition, all patients will not know about the studied drugs. Then the intensity of the patient's pain at time 0, 30 and 60 is evaluated based on the pain assessment criteria based on what is visible on the patient's face (VAS) and recorded in the information checklist.
Participants/Inclusion and exclusion criteria
Patients with epigastric pain referred to the emergency department of Khatam Zahedan Hospital in 1401 Non-entry conditions: Pregnancy, patients with unstable vital signs, receiving antacids/H2 receptor blockers/PPI within two hours before ED visit, known allergy to study agents, epigastric pain suspected of MI, age over 60 and under 18, cholecystitis, Suspicion of dissection
Intervention groups
Patients with epigastric pain referred to the emergency room of Khatam al-Anbia, Zahedan
Main outcome variables
Pain intensity after drug injection

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230614058478N1
Registration date: 2024-03-06, 1402/12/16
Registration timing: prospective

Last update: 2024-03-06, 1402/12/16
Update count: 0
Registration date
2024-03-06, 1402/12/16
Registrant information
Name
Mahjoube Keykha
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3661 2878
Email address
mahjoubehkeykha@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-20, 1403/01/01
Expected recruitment end date
2024-06-21, 1403/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the therapeutic effect of injectable pantoprazole and famotidine in patients with epigastric pain
Public title
Comparison of the therapeutic effect of injectable pantoprazole and famotidine in patients with epigastric pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with epigastric pain referred to the emergency department of Khatam Zahedan Hospital in 1401
Exclusion criteria:
- Unwillingness to participate in the study Pregnancy, patients with unstable vital signs, receiving antacids Receiving antacid/H2 receptor blockers/PPI within two hours before ED visit, known allergy to study agents Epigastric pain suspected of MI Age over 60 and under 18, cholecystitis, suspected dissection
Age
From 3 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Data and Safety Monitoring Board
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
To perform block randomization, in cases where the sample size is small and the tendency is that in each stage of the study, the number of samples in both arms of the study is almost equal, from blocks of four (equal number of each group in each Block = we use two samples from group A and two samples from group B in each block of four. Here, we have six different modes for how the samples are distributed within each block: . AABB 2. ABAB 3. ABBA 4. BBAA 5. BABA 6. BAAB Assuming that the sample size is 100, we need 25 blocks. Using the software, we do 25 times random sampling from 1 to 6 (number of different blocks) with placement. The above table is a random sample of 25 times of sampling from six blocks (with placement). way to do: The first block is block number 4 (BBAA), which means that the first and second patients receive drug B, and the third and fourth patients receive drug A. The next block is block 2 (ABAB) and as a result, the fifth person is drug A, the sixth person is drug B, the seventh person is drug A, and the eighth person is drug B, and so on.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study is a three-way blind study, so that the patient, doctor, and nurse do not know about the injectable drug, and only the pharmacist knows about the type of injectable drug, and the burial method is such that a code is given to each patient according to a random table, and the colleague According to the previous announcement, according to the code, the pharmacy provides the relevant medicine to the nurse The injection method of both drugs as well as the color and shape of both drugs are the same
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Jam Jam Boulevard, Khatam Square, Khatam Al Anbia Hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2022-11-20, 1401/08/29
Ethics committee reference number
IR.zaums.rec.1401.360

Health conditions studied

1

Description of health condition studied
epigastric pain
ICD-10 code
R10.1
ICD-10 code description
Pain localized to upper abdomen

Primary outcomes

1

Description
Pain intensity after drug injection
Timepoint
0-30-60 Minutes after receiving the medicine
Method of measurement
Assessing pain based on what is visible on the patient's face (VAS)

Secondary outcomes

empty

Intervention groups

1

Description
Internention group: receiving 40 mg of famotidine injection diluted in 100ml of normal saline solution as a rapid infusion in 2-4 minutes
Category
Treatment - Drugs

2

Description
Intervention group: receiving 40 mg of injectable pantoprazole diluted in 100 ml of normal saline solution as a rapid infusion in 2-4 minutes.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Khatam Al Anbia Hospital, Zahedan
Full name of responsible person
Mahjoobe Keikha
Street address
Jam Jam Boulevard, Khatam Square, Khatam Al Anbia Hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5765
Email
mahjoubehkeykha@zaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Ebrahim Kord
Street address
Zahedan - Doctor Hasabi Square - Medical Sciences Campus
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5765
Email
mahjoubehkeykha@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Mahjoube Keykha
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Jam Jam Boulevard, Khatam Square, Khatam Al Anbia Hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5765
Email
mahjoubehkeykha@zaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mahjoobe Keikha
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Jam Jam Boulevard, Khatam Square, Khatam Al Anbia Hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5765
Email
mahjoubehkeykha@zaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mahjoobe Keikha
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Jam Jam Boulevard, Khatam Square, Khatam Al Anbia Hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5765
Email
MahjoubehKeykha@zaums.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
All data can be shared after de-identifying individuals
When the data will become available and for how long
The access period starts one month after the results are published
To whom data/document is available
All researchers working in academic and hospital institutions and pharmaceutical companies
Under which criteria data/document could be used
It is allowed to be used in research and treatment works by mentioning the source
From where data/document is obtainable
mahjoubehkeykha@zaums.ac.ir Saharyoosefi96@gmail.com
What processes are involved for a request to access data/document
After sending an e-mail and a sufficient explanation about your desired research and the reason for using data information, the necessary checks will be done as soon as possible and then you will be allowed access.
Comments
Loading...