Comparison of the efficacy of intravenous Labetalol and the usual method (local anesthesia) on pain controlling and anxiety during bone marrow aspiration and biopsy
Evaluation of the efficacy of intravenous labetalol in comparison with the conventional method (local anesthesia) on pain control during bone marrow aspiration and biopsy
Design
A randomized, double blind, sham controlled clinical trial.
40 patients who are candidates for bone marrow aspiration and biopsy will be randomly divided into two intervention (intravenous Labetalol) and control groups.
Settings and conduct
Participants are patients who are candidates for bone marrow aspiration and biopsy who referred to the oncology ward of Semnan Kowsar Hospital.Patients will be randomly assigned to either the labaletol and control groups.The researcher and patient will be unaware of the grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria: over 18 years of age, definitive indication for bone marrow aspiration and biopsy.
Exclusion criteria: unwillingness to participate in study, cardiovascular disease (heart block, arrhythmia), uncontrolled chronic obstructive pulmonary disease, uncontrolled asthma, hypotension, consciousness disorder, bradycardia, pregnancy and lactation, using analgesics for the past 24 hours, elderly people with advanced systemic disease
Intervention groups
Patients in the intervention group will receive IV labetalol (5mg) in addition to Fentanyl and anesthesia. Patients in the control group will receive local anesthesia, Fentanyl and placebo.
Main outcome variables
Pain intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191201045563N1
Registration date:2020-01-05, 1398/10/15
Registration timing:registered_while_recruiting
Last update:2020-01-05, 1398/10/15
Update count:0
Registration date
2020-01-05, 1398/10/15
Registrant information
Name
Masoudeh Darzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3325 9150
Email address
masoudehdarzi@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-06, 1398/09/15
Expected recruitment end date
2020-02-04, 1398/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of intravenous Labetalol and the usual method (local anesthesia) on pain controlling and anxiety during bone marrow aspiration and biopsy
Public title
The efficacy of intravenous Labetalol on pain controlling and anxiety during bone marrow aspiration and biopsy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age more than 18 years old
Definitive indication of bone marrow aspiration and biopsy
Exclusion criteria:
Unwillingness to participate in the study
Cardiovascular disease (Heart block, Arrhythmia)
Uncontrolled chronic obstructive pulmonary disease
Uncontrolled Asthma
Unstable hemodynamics especially hypotension, bradycardia
Consciousness disorder
Pregnancy and lactation
Bad physical conditions
Using analgesic agents for the past 24 hours
Elderly people with advanced systemic disease
Vertigo, headache, dyspnea, nausea before the procedure
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
A simple random method using random numbers table;
with the help of someone other than the researcher, the sealed packets are prepared, on which the numbers are placed behind each other, in which the intervention or control group is determined according to the random number table.
َAnd the numbers are used for patients in the study, respectively.Thus, each patient is accidentally in the intervention or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Study participants, principal investigator and Statistical analyzer;The drug used in the control and intervention groups is administered by a person other than the principal investigator, the clinical caregiver.
the results of the data are presented in the form of groups called 1 and 2 to statistical classifiers.Although patients are given the necessary knowledge of the study and informed consent is obtained, they will not be informed about the group in which they are participating.
Placebo
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
Headquarters building of Semnan University of Medical Sciences, Basij blvd., Moallem Square
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2019-11-23, 1398/09/02
Ethics committee reference number
IR.SEMUMS.REC.1398.203
Health conditions studied
1
Description of health condition studied
Bone Marrow Aspiration and Biopsy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain intensity based on 10cm visual analogue scale(VAS)
Timepoint
During the procedure, 5 minutes and one hour after the procedure
Method of measurement
10cm visual analogue scale (VAS)
Secondary outcomes
1
Description
Anxiety score
Timepoint
30 minutes before starting the procedure and during the procedure