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Comparison of the effectiveness of ketamine and ketorolac infusion to control pain in adult patients

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History
# Registration date Revision Id
3 2024-06-15, 1403/03/26 305322
2 2023-06-26, 1402/04/05 269582
1 2023-04-29, 1402/02/09 262999
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  • Protocol summary

    Compression of the effectiveness of ketamine infusion in pain control in chest trauma
    Compression of the effectiveness of analgesic infusion in pain control in chest trauma Assessment of adverse effects/the need for morphine
    مقایسه اثربخشی انفوزیون کتامین در کنترل درد آسیب قفسه سینه
    مقایسه اثربخشی انفوزیون مسکن در کنترل درد آسیب قفسه سینه بررسی عوارض جانبی و نیاز به مورفین
    The study process is as follows: At first, patients enter the project in accordance with the conditions mentioned in the proposal and after being informed of the project conditions, they are transferred to the CPR room of Sina Hospital. In the absence of contraindications, they are injected with one gram of acetaminophen. Then they are randomly divided into two groups (under ketamine infusion) and (under ketrolak serum infusion of 30 mg). The drugs are prepared by the nurse and injected by the attending physician. The injection time of the drug is considered as zero time. And then the amount of pain is measured at 10, 30 and then every 30 minutes to two hours. If the patient's pain does not decrease during the mentioned times with the amount of injectable drug, morphine at the rate of 0.1 mg per weight is used and the patient's need for additional palliative drug is recorded in the file.
    Patients enter the project after being informed of the project conditions. In the absence of contraindications, they are injected with one gram of acetaminophen. Then they are randomly divided into two groups (under ketamine infusion) and (under ketorolac serum infusion of 30 mg). The drugs are prepared by the nurse and injected by the attending physician. The amount of pain is measured at 10, 30 and 60 minutes. If the patient's pain does not decrease during the mentioned times with the amount of injectable drug, morphine at the rate of 0.1 mg per weight is used.
    فرآیند مطالعه به این ترتیب می باشد که در ابتدا بیماران طابق با شرایط ذکر شده در پروپوزال وارد طرح شده و پس از اطلاع از شرایط طرح، به اطاق CPR اورژانس بیمارستان سینا منتقل می شوند. در صورت عدم وجود کنترااندیکاسیونی، تحت درمان تزریقی با یک گرم استامینوفن قرار می گیرند. سپس به صورت راندوم به دو گروه (تحت انفوزیون کتامین) و ( تحت انفوزیون سرم کترولاک 30 میلی گرم ) تقسیم می گردند. دارو ها توسط پرستار بخش CPR بیمارستان سینا اماده سازی شده و توسط پزشک حاضر تزریق می گردد. زمان تزریق دارو به عنوان زمان صفر در نظر گرفته می شود. پس از آن میزان درد در زمان 10، 30 و سپس هر 30 دقیقه تا دو ساعت سنجیده می شود. درصورتی که درد بیمار در زمان های مذکور با میزان داروی تزریقی کاهش نیافت از مورفین به میزان 0.1 میلی گرم به ازای وزن استفاده می شود و نیاز بیمار به داروی تسکینی اضافی در پرونده ثبت میگردد.
    بیماران پس از اطلاع از شرایط طرح وارد می شوند. در صورت عدم وجود کنترااندیکاسیونی، تحت درمان تزریقی با یک گرم استامینوفن قرار می گیرند. سپس به صورت راندوم به دو گروه (تحت انفوزیون کتامین) و ( تحت انفوزیون سرم کترولاک 30 میلی گرم ) تقسیم می گردند. دارو ها توسط پرستار بخش CPR بیمارستان سینا اماده سازی شده و توسط پزشک حاضر تزریق می گردد. میزان درد در زمان 10، 30 و 60 دقیقه سنجیده می شود. درصورتی که درد بیمار در زمان های مذکور با میزان داروی تزریقی کاهش نیافت از مورفین به میزان 0.1 میلی گرم به ازای وزن استفاده می شود.
    Patients enter the plan according to the conditions mentioned in the proposal randomly divided into two groups (under ketamine infusion) and (under ketrollak serum infusion of 30 mg).
    Patients enter the plan according to the conditions mentioned in the proposal randomly divided into two groups (under ketamine infusion) and (under ketorolac serum infusion of 30 mg).

  • General information

    2023-05-05, 1402/02/15
    2023-04-30, 1402/02/10
    2023-05-05, 1402/02/15
    2023-04-30, 1402/02/10
    empty
    To complete outcome measures To update the recruitment date
    empty
    تکمیل پیامدها به روز رسانی زمان شروع نمونه گیری

  • Recruitment centers

    #1
    Name of recruitment center - English: Sinal hospital
    Name of recruitment center - Persian: بیمارستان سینا
    Full name of responsible person - English: seyedeh zeynab seyedjavadeyn
    Full name of responsible person - Persian: سیده زینب سیدجوادین
    Street address - English: No. 64, Sattarkhan St., Niroo St., Sazman Ab St., after Shohada Mosque
    Street address - Persian: خیابان ستارخان، خیابان نیرو، خیابان سازمان آب، بعد از مسجد شهدا، پلاک 64
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1454873331
    Phone: +98 21 4424 7464
    Fax:
    Email: zeynabsdjvdn@gmail.com
    Web page address:
    Name of recruitment center - English: Sina hospital
    Name of recruitment center - Persian: بیمارستان سینا
    Full name of responsible person - English: Seyedeh Zeynab Seyedjavadeyn
    Full name of responsible person - Persian: سیده زینب سیدجوادین
    Street address - English: No. 64, Sattarkhan St., Niroo St., Sazman Ab St., after Shohada Mosque
    Street address - Persian: خیابان ستارخان، خیابان نیرو، خیابان سازمان آب، بعد از مسجد شهدا، پلاک 64
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1454873331
    Phone: +98 21 4424 7464
    Fax:
    Email: zeynabsdjvdn@gmail.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Vice President for Research and Technology
    Full name of responsible person - Persian: معاون تحقیقات و فناوری
    Street address - English: No. 64, Sattarkhan St., Niroo St., Sazman Ab St., after Shohada Mosque
    Street address - Persian: خیابان ستارخان، خیابان نیرو، خیابان سازمان آب، بعد از مسجد شهدا، پلاک 64
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1454873331
    Phone: +98 21 4424 7464
    Fax:
    Email: zeynabsdjvdn@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Akbar Fotouhi
    Full name of responsible person - Persian: اکبر فتوحی
    Street address - English: Blv. Keshavrz
    Street address - Persian: بلوار کشاورز
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 00141523
    Phone: +98 21 8899 2970
    Fax:
    Email: afotouhi@tums.ac.ir
    Web page address:

Protocol summary

Study aim
Compression of the effectiveness of analgesic infusion in pain control in chest trauma Assessment of adverse effects/the need for morphine
Design
Random, double-blind clinical trial with two experimental groups is performed on a total of 90 patients. Thus, based on the computer sequence, patients are randomly divided into two groups. In the blinding method, the volume and color of the drugs are simulated.
Settings and conduct
Patients enter the project after being informed of the project conditions. In the absence of contraindications, they are injected with one gram of acetaminophen. Then they are randomly divided into two groups (under ketamine infusion) and (under ketorolac serum infusion of 30 mg). The drugs are prepared by the nurse and injected by the attending physician. The amount of pain is measured at 10, 30 and 60 minutes. If the patient's pain does not decrease during the mentioned times with the amount of injectable drug, morphine at the rate of 0.1 mg per weight is used.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients >= 18 years old Patients with fractures of at least two ribs following penetrating or blunt trauma and the need chest tube placement Exclusion criteria: 1) History of allergies and drug reactions 2) GCS <=13 3) Heart failure 4) Increased ICP
Intervention groups
Patients enter the plan according to the conditions mentioned in the proposal randomly divided into two groups (under ketamine infusion) and (under ketorolac serum infusion of 30 mg).
Main outcome variables
The effect of ketamine on pain relief

General information

Reason for update
To complete outcome measures To update the recruitment date
Acronym
IRCT registration information
IRCT registration number: IRCT20210711051840N1
Registration date: 2023-04-29, 1402/02/09
Registration timing: prospective

Last update: 2023-06-27, 1402/04/06
Update count: 2
Registration date
2023-04-29, 1402/02/09
Registrant information
Name
seyedeh zeynab seyedjavadeyn
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4424 7464
Email address
zeynabsdjvdn@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-30, 1402/02/10
Expected recruitment end date
2023-09-22, 1402/06/31
Actual recruitment start date
2023-04-30, 1402/02/10
Actual recruitment end date
2023-09-22, 1402/06/31
Trial completion date
2023-10-02, 1402/07/10
Scientific title
Comparison of the effectiveness of ketamine and ketorolac infusion to control pain in adult patients
Public title
Comparison of the effectiveness of ketamine and ketorolac to control pain in patients with at least two rib fractures and patients in need of chest tube insertion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Age over 18 years 2. Patients with blunt and penetrating trauma, with a fracture of two ribs or more, or patients who need a chest tube insertion.
Exclusion criteria:
1. People who have a history of allergies and drug reactions, especially to ketamine. 2. People with <= 13 GCS 3. People with acute coronary syndrome 4. Increase ICP 5. Severe hypertension (systolic pressure = and <from 180 mm Hg or diastolic = and <from 100 mm Hg) 6. People who are currently taking MAO inhibitors. 7. People with a history of psychosis 8. Consumers of psychiatric drugs (Pschycotropic) 9. Active dementia or delirium 10. Glaucoma 11. Pregnancy 12. Inability to express pain or communicate with people 13. Liver failure 14. Patients with active bleeding 15. Patients with gastric ulcer 16. Thrombocytopenia
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data and Safety Monitoring Board
Sample size
Target sample size: 90
Actual sample size reached: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is performed using computer randomization sequence and by preparing quadruple blocks by block randomization method.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this way, based on the computer sequence, the patients are randomly divided into two groups. In the blinding method, the volume and color of the drugs are compared. Blinding is done by administering the same volume of two colorless drugs. In this way, 0.25 mg/kg of Ketamine drug with normal saline and Ketorolac 30 mg drug with normal saline, each until the unit volume of 5cc in 10 minutes is prescribed for blinding. The patients participating in the study and the doctor collecting the data and the evaluator do not know the type of prescribed medication.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
No. 64, Shohada Ab St., Niroo St., Niroo St., Sattarkhan St., Tehran
City
Tehran
Province
Tehran
Postal code
1434873331
Approval date
2021-06-15, 1400/03/25
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.278

Health conditions studied

1

Description of health condition studied
pain management
ICD-10 code
R07.81
ICD-10 code description
Pleurodynia

Primary outcomes

1

Description
Percentage of pain relief in response to ketamine
Timepoint
The basis of the amount of pain reported by the patient is measured at time zero (before drug injection), 10, 30 and then every 30 minutes to two hours.
Method of measurement
Numerical Rating Scale(NRS)

Secondary outcomes

empty

Intervention groups

1

Description
We inject 0.25 mg/kg of ketamine and prepare a 5 cc syringe in 10 minutes infusion for the study patients.
Category
Treatment - Surgery

2

Description
We inject the dose of 30 mg of ketorolac and prepare a 5 cc syringe in 10-minute infusion for the study patients.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Seyedeh Zeynab Seyedjavadeyn
Street address
No. 64, Sattarkhan St., Niroo St., Sazman Ab St., after Shohada Mosque
City
Tehran
Province
Tehran
Postal code
1454873331
Phone
+98 21 4424 7464
Email
zeynabsdjvdn@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Blv. Keshavrz
City
Tehran
Province
Tehran
Postal code
00141523
Phone
+98 21 8899 2970
Email
afotouhi@tums.ac.ir
Grant name
Seyedeh zeynab Seyedjavadeyn
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Hosein Zabihi
Position
professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Khomeini St., not far from Hassanabad Square, Sina Hospital
City
Tehran
Province
Tehran
Postal code
4691111367
Phone
00982163120
Email
zeynabsdjvdn@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Bahreini
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Imam Khomeini St., not far from Hassanabad Square, Sina Hospital
City
Tehran
Province
Tehran
Postal code
4691111367
Phone
00982163120
Email
bahreinimaryam@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyede Zeynab Seyedjavadeyn
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Imam Khomeini St., not far from Hassanabad Square, Sina Hospital
City
Tehran
Province
Tehran
Postal code
4691111367
Phone
00982163120
Email
zeynabsdjvdn@gmail.com

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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data related to the analgesic effects of the studied drugs can be shared.
When the data will become available and for how long
Start the data access period one month after the results are published
To whom data/document is available
Accessible to researchers working in academic institutions
Under which criteria data/document could be used
Research progress
From where data/document is obtainable
seyedeh zeynab seyedjavadeyn zeynabsdjvdn@gmail.com
What processes are involved for a request to access data/document
The applicant must state the reason for the need for the data at the email address. After examining the causes, the results will be provided.
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