Injection Pain Prevention Clinical Trial
Official title:
A Randomized Controlled Trial Evaluating Three Non-invasive Analgesic Techniques in Pain Prevention During Injections
Injections are associated to a certain level of pain which tolerance can vary between
individuals. As regards non-invasive pain control techniques in subcutaneous injections,
scarce literature exists with adequate levels of evidence and design quality to support any
specific analgesic method.
In this study, the investigators evaluated the effectivity of three non-invasive analgesic
techniques (cold, anesthetic cream and vibration) when performing subcutaneous forehead
injections, in a series of 100 healthy volunteers.
This study is a randomized, controlled, simple-blind clinical trial, and it has been approved
by the Ethics Committee of the Medical Research Institute Hospital La Fe. The study included
100 healthy volunteered, and it was performed in the University and Polytechnic Hospital La
Fe, Valencia.
The procedures of the study consisted in the sequential performance of four injections of
0,1mL of physiologic saline (0,9%NaCl) in the forehead of each subject, 2cm above the
eyebrows, with a 29G needle, after applying any of the non-invasive anesthetic methods
studied in the trial, except for the control zone. The anesthetic method utilized in each
part of the forehead of each patient was randomized through simple randomization. Injections
always started from the right side of the forehead to the left. The non-invasive analgesic
methods utilized were:
- Control zone: None
- Vibration: Application of the vibrating device on the skin below the injection site,
before and during injection.
- Cold: Application of a bag of 50mL of frozen physiologic saline covered with a plastic
glove on the injection site for 50 seconds prior to performing the injection.
- Anesthetic cream: Application of a uniform thickness of 2mm of the anesthetic cream EMLA
covered with an adhesive transparent plastic dressing for 30 minutes, before injection.
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