Protocol summary

Study aim
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
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 44 patients. Random allocation software was used for randomization
Settings and conduct
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
Participants/Inclusion and exclusion criteria
Inclusion criteria Age 18 -55 years Conscious consent to enter the study Exclusion criteria Mental inability to express pain
Intervention groups
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
Main outcome variables
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.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200427047215N2
Registration date: 2021-01-16, 1399/10/27
Registration timing: prospective

Last update: 2021-01-16, 1399/10/27
Update count: 0
Registration date
2021-01-16, 1399/10/27
Registrant information
Name
Ali Darakhshandeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3777 2640
Email address
alidarakhshandeh@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-19, 1399/10/30
Expected recruitment end date
2021-11-21, 1400/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining and comparing the effectiveness of intravenous injection of apotel, promethazine syrup and local anesthesia with intravenous injection of pethidine and local anesthesia in controlling pain in patients candidate for bone marrow aspiration and biopsy.
Public title
Pain control in bone marrow aspiration and biopsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-55 years Conscious consent to enter the study BMI 18-25
Exclusion criteria:
Mental retardation Generalized anxiety disorder Major Depressive Disorder Pregnancy Lactation Drug addiction Take analgesic less than 4 hours before admission Hypersensitivity to apotel, promethazine and lidocaine GFR < 30 Cirrhosis Child B & C
Age
From 18 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with confirmed inclusion criteria are selected through easy sampling and are placed in case or control group with random allocation software
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients, the main researcher, the physician and the nursing staff are kept blind to the allocation of study groups. The lidocaine injection and BMA / B process is performed by a hematologist-oncologist for all subjects. The nurse and physician who perform the injection and the procedure, as well as the patient, are unaware of the patient group.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
No 566,Saadat Ave, Molana Blvd, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174797677
Approval date
2020-12-12, 1399/09/22
Ethics committee reference number
IR.MUI.MED.REC.1399.817

Health conditions studied

1

Description of health condition studied
Bone marrow disease
ICD-10 code
C90
ICD-10 code description
Multiple myeloma and malignant plasma cell neoplasms

Primary outcomes

1

Description
Reduction of pain during bone marrow biopsy and aspiration
Timepoint
Immediately after completing the procedure and 30 minutes later in the intervention and control groups
Method of measurement
To estimate the severity of pain and the effect of the drug in relieving the patient's pain from the quantitative scale VAS(Visual Analog Scale) is used.

2

Description
Anxiety after completing the procedure
Timepoint
After the procedure and 30 minutes later, the patient's anxiety is rated from 1 to 10, depending on the severity.
Method of measurement
Anxiety severity is divided from zero to ten using a questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 1. Infusion of one gram ampoule in 100 cc of normal saline serum half an hour before the procedure 2. 5 cc of promethazine syrup (25 mg) 30 minutes before the procedure 3. Intravenous injection of 1 cc ampoule containing normal saline fifteen minutes before the procedure 4. Topical injection of 10 cc of 1% lidocaine, 3 minutes before the procedure
Category
Treatment - Drugs

2

Description
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 25 mg of pethidine 15 minutes before the procedure 4. Topical injection of 10 cc of 1% lidocaine, 3 minutes before the procedure
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Omid Hospital.Isfahan
Full name of responsible person
Ali Darakhshandeh
Street address
No 566, 13 Alley, Saadat streat, Janbazan Blvd, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174797677
Phone
+98 31 3777 1870
Email
alidarakhshandeh@med.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Hezar Jarib Ave,Isfahan univercity of medical sciences
City
Isfahan
Province
Isfehan
Postal code
73461- 81746
Phone
+98 31 3668 0048
Email
isfahan.med@mui.ac.ir
Web page address
http://med.mui.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Ali Darakhshandeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology and Medical Oncology
Street address
No 566A. 13 Alley, Saadat Ave, molana Ave, Janbazan Ave
City
Isfahan
Province
Isfehan
Postal code
8174797677
Phone
+98 31 3777 2640
Fax
Email
alidarakhshandeh@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Darakhshandeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
No 566A. 13 Alley, Saadat Ave, molana Ave, Janbazan Ave.
City
Isfahan
Province
Isfehan
Postal code
8174797677
Phone
+98 31 3777 2640
Fax
Email
alidarakhshandeh@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Darakhshandeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
No 566A. 13 Alley, Saadat Ave, molana Ave, Janbazan Ave.
City
Isfahan
Province
Isfehan
Postal code
8174797677
Phone
+98 31 3777 2640
Fax
Email
alidarakhshandeh@med.mui.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
Start of access period of the year 1400
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Information will be shared if applicants make their request clear and explicit
From where data/document is obtainable
Request by email with the designer of the study
What processes are involved for a request to access data/document
If we receive an email to receive information; The application will be reviewed by the study planners and emailed to them if there is no prohibition.
Comments
Loading...