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General information
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200
200
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2020-05-04, 1399/02/15
2020-05-04 00:00:00
empty
2020-11-20, 1399/08/30
2020-11-20 00:00:00
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2020-11-20, 1399/08/30
2020-11-20 00:00:00
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Add a definite start and end date for sampling
Add a definite start and end date for sampling
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اضافه کردن تاریخ قطعی شروع و خاتمه ی نمونه گیری
اضافه کردن تاریخ قطعی شروع و خاتمه ی نمونه گیری
Protocol summary
Study aim
Comparison of analgesic effects of ketamine-midazolam and apotel-ketorolac in renal colic patients
Design
Randomized clinical trial with 200 samples which randomly divided into groups A and B using ten-person blocks.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
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
Reason for update
Add a definite start and end date for sampling
Acronym
IRCT registration information
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
Registration date
2020-05-01, 1399/02/12
Registrant information
Name
Anvar Bahrami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3366 4674
Email address
bahramianvar92@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
2020-05-04, 1399/02/15
Actual recruitment end date
2020-11-20, 1399/08/30
Trial completion date
2020-11-20, 1399/08/30
Scientific title
Comparison of analgesic effects of ketamine-midazolam and apotel-ketorolac in renal colic patients
Public title
Analgesic effects of ketamine-midazolam and apotel-ketorolac in renal colic patients
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
200
Actual sample size reached:
200
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Pasdaran St., Kurdistan University of Medical Sciences, Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Approval date
2019-09-08, 1398/06/17
Ethics committee reference number
IR.MUK.REC.1398.120
Health conditions studied
1
Description of health condition studied
Renal colic
ICD-10 code
N23
ICD-10 code description
Unspecified renal colic
Primary outcomes
1
Description
Pain
Timepoint
One, five, ten, fifteen, thirty and forty-five minutes after drug injection
Method of measurement
It will be determined based on the Numeric Rating Scale system
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
Control group: For patients in the control group, 30 mg Ketorolac and 15 mg apotel based on body weight are injected.