The comparison of effect of applying tetracaine 4% gel and evaporative anesthesia spray on the intensity of pain caused by blood intravenous injection in patients with thalassemia
The aim of this study was to compare the effect of tetracaine 4% gel and evaporative anesthesia spray to reduce the pain of intravenous blood injection.
This study is an interventional study and of a randomized clinical trial type that will be done on patients with thalassemia. The population of the study consists of patients with thalassemia visiting thalassemia center. Inclusion criteria for this study: patients 12 to 40 years that well understand the concept of numbers, and are not affected with contextual disease.
Exclusion criteria: dispensing with participating in the study, being with side effects in venipuncture.
In this study, after determining the sample size based on similar studies 90 patients who have the criteria to participate in the study are selected and we divide treatment between them randomly into three groups of 30 with random block division method. In the first group, Tetracaine 4% gel will be used in 3 grams in an area with the size of 10 cm square with a light dressing for 30 minutes before intravenous injection and then gels are cleaned and injection will take place. In the second group, evaporative spray will be used; in this way that it will be sprayed out at room temperature by a researcher from a distance of 25 cm for 5-10 seconds until being the skin white and pale and then because of a short effect of 30-40 seconds later the injection will be carried out. In the third group, the injection will be done with no interventional agent.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016112219862N3
Registration date:2017-05-13, 1396/02/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-13, 1396/02/23
Registrant information
Name
Sakine Sabzevari
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5219
Email address
s_sabzevari@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental
Expected recruitment start date
2016-12-15, 1395/09/25
Expected recruitment end date
2017-01-14, 1395/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of effect of applying tetracaine 4% gel and evaporative anesthesia spray on the intensity of pain caused by blood intravenous injection in patients with thalassemia
Public title
The effect of tetracaine 4% gel and evaporative spray on reducing the pain of intravenous blood injection in patients with thalassemia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients 12 to 40 years; Have file from the Thalassemia Center; Satisfaction of participate in the study; Insensitivity to use any of the intervention; Full awareness of time; Place and person.
Exclusion criteria: Patients who have suffered physical and psychological problems and drugs that reduce pain and anxiety consume; Do not understand the concept of numbers; An underlying disease such as diabetes and Login more than once catheter.
Age
From 12 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kerman University of Medical Sciences Ethics Commitee
Street address
Razi School of Nursing And Midwiferi, Haftbaq Alavi Street, Kerman
City
Kerman
Postal code
Approval date
2016-09-21, 1395/06/31
Ethics committee reference number
IR.KMU.REC.1395.95
Health conditions studied
1
Description of health condition studied
Thalassemia
ICD-10 code
D56
ICD-10 code description
Thalassaemia
Primary outcomes
1
Description
intensity of pain
Timepoint
Immediately after the intervention
Method of measurement
Numerical scale (NRS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Groups: 1) Gel: tetracaine gel 4%. amount of 3 grams. An area of 10 square centimeters. for 45 minutes.
Category
Treatment - Drugs
2
Description
Intervention Groups: 2) spray: Spray evaporate, at a distance of 25 cm from the site of injection for 5 to 10 seconds