1. Home
  2. Approved trials
  3. » فارسی

Comparing the effect of fentanyl in addition to oxygen therapy on pain in patients undergoing bone marrow aspiration and biopsy

Protocol summary

Study aim
The aim of this study was to compare the effect of fentanyl with and without oxygen therapy and placebo on pain in patients undergoing aspiration and bone marrow biopsy.
Design
In randomized, double-blinded, controlled clinical trial, phase 3, 60 patients, who are referred for bone marrow aspiration and biopsy, are randomly divided into three groups including: intervention groups A and B, and control group.
Settings and conduct
This study is conducted at Kowsar Hospital, an academic hospital affiliated with the Semnan University of Medical Sciences and Health Services. In this clinical trial, patients are randomly assigned to three groups and interventions are conducted. Intervention group A receive 2 mL fentanyl intravenously, intervention group B receive 2 mL fentanyl intravenously in addition to oxygen, before and during the procedure. The control group (C) receive oxygen for 30 minutes before and during the procedure. Person who evaluated outcomes and patients are not aware from the type of intervention.
Participants/Inclusion and exclusion criteria
Study population include patients who are referred for bone marrow aspiration and biopsy. All patients older than 18 years old and who have complete awareness enrolled in study. Patients who use narcotics and analgesic, need to oxygen therapy, those who have pacemaker and pregnant women are excluded from study.
Intervention groups
Intervention group A receive 2 mL fentanyl intravenously after local anesthesia. Intervention group B receive 2 mL fentanyl intravenously after local anesthesia in addition to oxygen, 8 liters per minute through face mask for 30 minutes before and during the diagnostic procedure. The control group (C) receive oxygen through face mask for 30 minutes before and during the procedure.
Main outcome variables
The main outcome is pain in the site of biopsy.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151020024625N9
Registration date: 2018-09-14, 1397/06/23
Registration timing: registered_while_recruiting

Last update: 2018-09-14, 1397/06/23
Update count: 0
Registration date
2018-09-14, 1397/06/23
Registrant information
Name
Mehrdad Zahmatkesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3343 7844
Email address
mehrdadzahmatkesh@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2019-02-03, 1397/11/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of fentanyl in addition to oxygen therapy on pain in patients undergoing bone marrow aspiration and biopsy
Public title
Effect of fentanyl in addition to oxygen therapy in relieving pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age older 18 years Complete consciousness
Exclusion criteria:
Pregnancy Pacemaker Any diseases that need to oxygen therapy
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly allocated in two groups by using of random number block. Random numbers can be generated by computer. The first block is allocated to intervention group A, second block is allocated to intervention group B and third block is allocated to control group and this process continues until the last block.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patient and care provider don't aware from intervention.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Semnan University of Medical Sciences
Street address
Basidj Boulevard
City
Semnan
Province
Semnan
Postal code
3519899951
Approval date
2018-02-06, 1396/11/17
Ethics committee reference number
IR.SEMUMS.REC.1396.226

Health conditions studied

1

Description of health condition studied
Pain
ICD-10 code
R52.9
ICD-10 code description
Pain, unspecified

Primary outcomes

1

Description
Pain Relief
Timepoint
After Intervention
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group A receive 2 mL fentanyl intravenously after local anesthesia
Category
Treatment - Drugs

2

Description
Intervention Group B receives 8 liters per minute of oxygen through face mask for 30 minutes before and during the procedure, in addition to fentanyl 2 mL intravenously.
Category
Treatment - Drugs

3

Description
Control group only receive oxygen through face mask for 30 minutes before and during the procedure:
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Kowsar Hospital, Semnan
Full name of responsible person
Farahnaz ghahremanfard
Street address
Basidj Boulevard
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2120
Email
f_ghahremanfard@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaei PhD
Street address
Basidj Boulevard
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3345 1336
Email
p_kokha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Mehrdad Zahmatkesh
Position
Research Expert
Latest degree
Bachelor
Other areas of specialty/work
Biostatistics
Street address
Basidj Boulevard
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2252
Email
mehrdadzahmatkesh@semums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Farahnaz Ghahremanfard MD
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Basidj Boulevard
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2120
Email
f_ghahremanfard@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mehrdad Zahmatkesh
Position
Research Expert
Latest degree
Bachelor
Other areas of specialty/work
Biostatistics
Street address
Basidj Boulevard
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2252
Email
mehrdadzahmatkesh@semums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Final report will published after completing of study.
When the data will become available and for how long
After publishing of results.
To whom data/document is available
Researcher and others for similar studies.
Under which criteria data/document could be used
Researchers and specialists
From where data/document is obtainable
by email.
What processes are involved for a request to access data/document
Providing of scientific ID.
Comments
Loading...