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IRCT20090613002027N13 IRCT 2018-08-04 Mazandaran University of Medical Sciences Effect of Oxycodone plus Lorazepam in pain induced by Bone marrow Aspiration and Biopsy Evaluation of the effect of Oxycodone plus Lidocaine plus Lorazepam in combination versus Lidocaine alone in pain induced by Bone marrow Aspiration and Biopsy (BMAB) in Mazandaran Cancer Center 2018-08-23 anticipated 80 Complete https://irct.ir/trial/1655 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients will enter the trial randomly based on the random number table, Blinding description: Assignment of patients to different groups of the study will be determined based on digit random table. Placebo of Oxycodone and Lorazepam will be prepared in the Faculty of Pharmacy of Sari. A unique Five-digit number will be assigned for each patient. The intervention (drug or placebo) will be put in the envelopes and the nurse of oncology division will give the intervention to the patients according to predetermined codes before Bone marrow aspiration/biopsy. The patient, physician and the assessor will be blinded regarding the type of intervention. 2 bone marrow and aspiration biopsy related pain. Intervention 1: 5ml lidocaine hydrochloride 1% during bone marrow aspiration and biopsy. Intervention 2: 2mg lorazepam tablet 30 minutes before bone marrow aspiration and biopsy. Intervention 3: 10mg oxycodone tablet 30 minutes before bone marrow aspiration and biopsy. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Ebrahim Salehifar
School of Pharmacy of Mazandaran University of Medical Sciences, Payambar azam University Complex, Farah Abad road, Sari, Iran
Sari Iran (Islamic Republic of) 861-48175 +98 11 3354 3241 salehifare@yahoo.com Faculty of Pharmacy, Mazandaran University of Medical Sciences scientific Ebrahim Salehifar
Faculty of Pharmacy, Payambar Azam Complex, 18 Km Farah Abad Blvd, Khazar squar
sari Iran (Islamic Republic of) 861-48175 +98 11 3354 3241 salehifare@yahoo.com Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients older than 18 years (inpatient or outpatient) Patients who are candidate for Bone Marrow Aspiration and Biopsy (BMAB) in Mazandaran Cancer Center 18 years no limit Both Mental disorder Language problems Unwillingness to participate in the study T81.9 Unspecified complication of procedure Treatment - Drugs Treatment - Drugs Treatment - Drugs 5ml lidocaine hydrochloride 1% during bone marrow aspiration and biopsy 2mg lorazepam tablet 30 minutes before bone marrow aspiration and biopsy 10mg oxycodone tablet 30 minutes before bone marrow aspiration and biopsy Pain Score following bone marrow aspiration/biopsy. Timepoint: 10 minutes following Bone marrow Aspiration and Biopsy. Method of measurement: Visual Analogue Scale. Mazandaran University of Medical Sciences Approved 2018-06-25 Ethics Committee of mazandaran University of Medical Sciences Mazandaran University of Medical Scienses, kilometer 18 of Farah Abad road, Sari, Iran Sari Mazandaran Iran (Islamic Republic of)