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Study aim
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Evaluation and comparison of analgesic effect of intravenous apotel, promethazine syrup and local anesthesia with intravenous pethidine injection and local anesthesia in bone marrow biopsy
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Design
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Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 44 patients. Random allocation software was used for randomization
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Settings and conduct
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The lidocaine injection and BMA / B process is performed by a hematologist-oncologist for all subjects. The nurse and physician who perform the procedure, as well as the patient, are unaware of the code assignment.
In this study, physician, patient and nurse are blind to the study
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Participants/Inclusion and exclusion criteria
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Inclusion criteria
Age 18 -55 years
Conscious consent to enter the study
Exclusion criteria
Mental inability to express pain
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Intervention groups
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Case group:
1. Infusion of 1 gram apotel in 100 cc of normal saline half an hour before the procedure
2. Promethazine syrup (25 mg) 30 minutes before the procedure
3. Intravenous injection of 1 cc normal saline fifteen minutes before the procedure
4.Topical injection of 10 cc of 1% lidocaine, 3 minutes before the procedure
Control group:
1.Infusion of 100 cc of normal saline serum half an hour before the procedure
2.Five cc of colored syrup without medication 30 minutes before the procedure
3.Intravenous injection of pethidine (25 mg) 15 minutes before the procedure
4.Topical injection of 10 cc of 1% lidocaine, 3 minutes before the procedure
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Main outcome variables
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A questionnaire is prepared for each patient in advance and is given to the patient after the procedure. This questionnaire includes the following two questions:
1. After the procedure and 30 minutes later, the patient's pain is estimated
2. Anxiety: After the procedure and 30 minutes after that, the patient's level of anxiety is ranked from 1 to 10, depending on the severity.