Protocol summary
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Study aim
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Comparison of analgesic effects of ketamine-midazolam and apotel-ketorolac in renal colic patients
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Design
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Randomized clinical trial with 200 samples which randomly divided into groups A and B using ten-person blocks.
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Settings and conduct
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This study will be conducted in Kowsar Hospital in Sanandaj city. The aim of this study is to compare the analgesic effects of ketamine-midazolam and apotel-ketorolac in renal colic patients. The researcher and the patients are unaware of grouping, therefore the study is double blind.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria: renal colic patients whose initial pain is greater than or equal to 8 according to the Numeric Ranking Scale system. Exclusion Criteria: patients with schizophrenia, asthma, cardiovascular disease and hypertension; significant head trauma; pregnancy or suspected; active lung infection; hemodynamic instability; respiratory distress or active hypoxemia; sensitivity to acetaminophen; severe liver failure; active liver disease; active gastric ulcer or its history; any suspicion of active bleeding; sensitivity to NSAIDs or aspirin; patients with kidney disease; taking painkillers (NSAIDs, acetaminophen, opioids) in the last 4 hours; glaucoma; patient's refusal to continue participating in the study; normal urine analysis (UA); inability to understand the concept of NRS system.
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Intervention groups
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Intervention group: for patients in the intervention group, 0.016 mg / kg midazolam and 0.4 mg / kg ketamine based on body weight are injected. Control group: for patients in the control group, 30 mg Ketorolac and 15 mg apotel based on body weight are injected.
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Main outcome variables
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The primary outcome is the pain which determined based on NRS, one, five, ten, fifteen, thirty and forty-five minutes after drug injection.
General information
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Reason for update
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Add a definite start and end date for sampling
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200422047163N1
Registration date:
2020-05-01, 1399/02/12
Registration timing:
prospective
Last update:
2021-05-21, 1400/02/31
Update count:
1
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Registration date
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2020-05-01, 1399/02/12
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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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2019-12-22, 1398/10/01
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Expected recruitment end date
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2020-08-22, 1399/06/01
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Actual recruitment start date
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2020-05-04, 1399/02/15
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Actual recruitment end date
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2020-11-20, 1399/08/30
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Trial completion date
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2020-11-20, 1399/08/30
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Scientific title
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Comparison of analgesic effects of ketamine-midazolam and apotel-ketorolac in renal colic patients
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Public title
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Analgesic effects of ketamine-midazolam and apotel-ketorolac in renal colic patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Renal colic patients whose initial pain is greater than or equal to 8 according to the Numeric Ranking Scale system
Exclusion criteria:
Patients with schizophrenia, asthma, cardiovascular disease and hypertension
Significant head trauma
Pregnancy or suspected
Active lung infection
Hemodynamic instability
Respiratory distress or active hypoxemia
Sensitivity to acetaminophen
Severe liver failure
Active liver disease
Active gastric ulcer or its history
Any suspicion of active bleeding
Sensitivity to NSAIDs or aspirin
Patients with kidney disease
Taking painkillers (NSAIDs, acetaminophen, opioids) in the last 4 hours
Glaucoma
The patient's refusal to continue participating in the study
Normal urine analysis (UA)
Inability to understand the concept of NRS system
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Age
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From 18 years old to 65 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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Sample size
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Target sample size:
200
Actual sample size reached:
200
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Samples are randomly divided into groups A and B using ten-person blocks. Based on time for patients referring to emergency room, the first ten patients will be allocated to group A and the next ten will be allocated to group B.This continues until the end of sampling.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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This is a double blind clinical trial. Patients are unaware of the grouping. Also, the person who is following the patient in terms of response to treatment and pain change (researcher student), does not know the injected drug belongs to intervention or control group.
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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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2019-09-08, 1398/06/17
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Ethics committee reference number
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IR.MUK.REC.1398.120
Health conditions studied
1
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Description of health condition studied
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Renal colic
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ICD-10 code
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N23
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ICD-10 code description
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Unspecified renal colic
Primary outcomes
1
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Description
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Pain
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Timepoint
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One, five, ten, fifteen, thirty and forty-five minutes after drug injection
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Method of measurement
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It will be determined based on the Numeric Rating Scale system
Intervention groups
1
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Description
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Intervention group: For patients in the intervention group, 0.016 mg / kg midazolam and 0.4 mg / kg ketamine based on body weight are injected.
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Category
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Treatment - Drugs
2
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Description
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Control group: For patients in the control group, 30 mg Ketorolac and 15 mg apotel based on body weight are injected.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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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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Sanandaj 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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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Data on the main outcome of the study can be shared.
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When the data will become available and for how long
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One year after the publication the data will be available.
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To whom data/document is available
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Researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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Meta-analysis is allowed on the data of this study.
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From where data/document is obtainable
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Dr. Anvar Bahrami, Pasdaran St., Kurdistan University of Medical Sciences, Sanandaj, Iran , Email: bahramianvar92@gmail.com
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What processes are involved for a request to access data/document
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After one year of publishing the article and publishing the results, those who need the data of this study, could apply via email.
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Comments
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