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
Evaluation of the effect of Oxycodone plus Lidocaine plus Lorazepam in combination versus Lidocaine alone in pain induced by Bone marrow Aspiration and Biopsy
Design
Randomized two parallel group clinical trial with blinded outcome assessment
Settings and conduct
The study will be done in Imam Khomeini hospital of Sari.
Forty patients will be included in each arm of the study. Patients, physicians and assessor will be blinded regarding grouping of the patients. Assignment to two arms of the study will be done using random digit table.
Participants/Inclusion and exclusion criteria
]nclusion criteria:
1- Patients older than 18 years (inpatient or outpatient)
2- Patients who are candidate for Bone Marrow Aspiration and Biopsy (BMAB)
Exclusion criteria:
1- Mental disorder
2- Language problems
3- Unwillingness to participate in the study
Intervention groups
In one group, patients will receive only subcutaneous injection of lidocaine hydrochloride 1%, and in the other group, patients will be given tablet lorazepam (2 mg) and tablet oxycodone (10 mg) half an hour before BMAB and lidocaine as subcutaneous injection before BMAB.
Main outcome variables
1- Pain score based on visual analogue score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090613002027N13
Registration date:2018-08-04, 1397/05/13
Registration timing:prospective
Last update:2018-08-04, 1397/05/13
Update count:0
Registration date
2018-08-04, 1397/05/13
Registrant information
Name
Ebrahim Salehifar
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1311 6546
Email address
esalehifar@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research and Technology deputy of Mazandaran University of Medical Sciences
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Effect of Oxycodone plus Lorazepam in pain induced by Bone marrow Aspiration and Biopsy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients older than 18 years (inpatient or outpatient)
Patients who are candidate for Bone Marrow Aspiration and Biopsy (BMAB) in Mazandaran Cancer Center
Exclusion criteria:
Mental disorder
Language problems
Unwillingness to participate in the study
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will enter the trial randomly based on the random number table.
Blinding (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Scienses, kilometer 18 of Farah Abad road, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4816633131
Approval date
2018-06-25, 1397/04/04
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1397.1703
Health conditions studied
1
Description of health condition studied
bone marrow and aspiration biopsy related pain
ICD-10 code
T81.9
ICD-10 code description
Unspecified complication of procedure
Primary outcomes
1
Description
Pain Score following bone marrow aspiration/biopsy
Timepoint
10 minutes following Bone marrow Aspiration and Biopsy
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
5ml lidocaine hydrochloride 1% during bone marrow aspiration and biopsy
Category
Treatment - Drugs
2
Description
2mg lorazepam tablet 30 minutes before bone marrow aspiration and biopsy
Category
Treatment - Drugs
3
Description
10mg oxycodone tablet 30 minutes before bone marrow aspiration and biopsy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital of Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Salehifar
Street address
Amir Mazandarani Boulevard
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
esalehifar@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Majid Saeedi
Street address
Research Deputy, Mazandaran university of medical Sciences, Moallem Square, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
861-48175
Phone
+98 11 3354 3241
Email
Esalehifar@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of Pharmacy, Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Salehifar
Position
Professor of Clinical Pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Clinical Pharmacist
Street address
School of Pharmacy of Mazandaran University of Medical Sciences, Payambar azam University Complex, Farah Abad road, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
861-48175
Phone
+98 11 3354 3241
Fax
Email
salehifare@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Salehifar
Position
Professor of Clinical Pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
clinical pharmacy
Street address
Faculty of Pharmacy, Payambar Azam Complex, 18 Km Farah Abad Blvd, Khazar squar
City
sari
Province
Mazandaran
Postal code
861-48175
Phone
+98 11 3354 3241
Fax
Email
salehifare@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Salehifar
Position
Professor of Clinical Pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
clinical pharmacy
Street address
School of Pharmacy of Mazandaran University of Medical Sciences, Payambar azam University Complex, Farah Abad road, Khazar Square
City
Sari
Province
Mazandaran
Postal code
861-48175
Phone
+98 11 3354 3241
Fax
Email
salehifare@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available