Protocol summary
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Study aim
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Compression of the effectiveness of analgesic infusion in pain control in chest trauma
Assessment of adverse effects/the need for morphine
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Design
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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.
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Settings and conduct
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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 5 , 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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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).
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Main outcome variables
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The effect of ketamine on pain relief
General information
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Reason for update
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To complete outcome measures
To update the recruitment date
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210711051840N1
Registration date:
2023-04-29, 1402/02/09
Registration timing:
prospective
Last update:
2024-06-17, 1403/03/28
Update count:
2
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Registration date
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2023-04-29, 1402/02/09
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-04-30, 1402/02/10
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Expected recruitment end date
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2023-09-22, 1402/06/31
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Actual recruitment start date
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2023-04-30, 1402/02/10
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Actual recruitment end date
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2023-09-22, 1402/06/31
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Trial completion date
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2023-10-02, 1402/07/10
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Scientific title
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Comparison of the effectiveness of ketamine and ketorolac infusion to control pain in adult patients
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Public title
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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
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
90
Actual sample size reached:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization is performed using computer randomization sequence and by preparing quadruple blocks by block randomization method.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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 5 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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-06-15, 1400/03/25
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Ethics committee reference number
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IR.TUMS.MEDICINE.REC.1400.278
Health conditions studied
1
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Description of health condition studied
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pain management
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ICD-10 code
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R07.81
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ICD-10 code description
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Pleurodynia
Primary outcomes
1
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Description
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Percentage of pain relief in response to ketamine
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Timepoint
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The basis of the amount of pain reported by the patient is measured at time zero (before drug injection), 5, 30 and then every 30 minutes to two hours.
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Method of measurement
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Numerical Rating Scale(NRS)
Intervention groups
1
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Description
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We inject 0.25 mg/kg of ketamine and prepare a 5 cc syringe in 5 minutes infusion for the study patients.
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Category
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Treatment - Surgery
2
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Description
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We inject the dose of 30 mg of ketorolac and prepare a 5 cc syringe in 5-minute infusion for the study patients.
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Category
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Treatment - Surgery
1
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Sponsor
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Grant name
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Seyedeh zeynab Seyedjavadeyn
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Data related to the analgesic effects of the studied drugs can be shared.
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When the data will become available and for how long
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Start the data access period one month after the results are published
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To whom data/document is available
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Accessible to researchers working in academic institutions
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Under which criteria data/document could be used
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Research progress
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From where data/document is obtainable
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seyedeh zeynab seyedjavadeyn
zeynabsdjvdn@gmail.com
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What processes are involved for a request to access data/document
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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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Comments
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