Evaluation of Three Non-invasive Analgesic Techniques in Pain Prevention During Injections

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Controlled Trial Evaluating Three Non-invasive Analgesic Techniques in Pain Prevention During Injections

Conditions
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Injection Pain Prevention

Intervention / Treatment
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* Combination Product: Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Every subject who did not meet any of the exclusion criteria, and signed the informed consent, was included in the study Exclusion Criteria: Subjects younger than 18 Subjects that suffered from any local or systemic sensitivity alteration Subjects that suffered from any cognitive deficit Individuals allergic to any of the components of the anesthetic ointment EMLA (eutectic mixture of lidocaine 2,5% and prilocaine 2,5%).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: All subjects received four injections of 0,1mL of physiologic saline (0,9%NaCl) in the forehead, 2cm above the eyebrows, with a 29G needle, after applying each one of the 4 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>A subcutaneous injection of 0,1mL saline (0,9%NaCl) was administered in a part of the forehead, without administering any type of non-invasive analgesic | Combination Product: Injection<br>* All information is included in the Arm/group descriptions<br>|
| Experimental: Vibration<br>A subcutaneous injection of 0,1mL saline (0,9%NaCl) was administered in a part of the forehead, while applicating a vibrating device on the skin below the injection site, before and during injection. | Combination Product: Injection<br>* All information is included in the Arm/group descriptions<br>|
| Experimental: Cold<br>A subcutaneous injection of 0,1mL saline (0,9%NaCl) was administered in a part of the forehead, after applicating a bag of 50mL of frozen physiologic saline covered with a plastic glove on the injection site for 50 seconds | Combination Product: Injection<br>* All information is included in the Arm/group descriptions<br>|
| Experimental: Anesthetic cream<br>subcutaneous injection of 0,1mL saline (0,9%NaCl) was administered in a part of the forehead, after applicating a uniform thickness of 2mm of the anesthetic cream EMLA covered with an adhesive transparent plastic dressing for 30 minutes | Combination Product: Injection<br>* All information is included in the Arm/group descriptions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain referred per each zone injected: VAS | Pain measured through a Visual Analogic Scale with values from 0 to 10; being 0 complete absence of pain, and 10 the worst pain ever experienced. | 1 hour max | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discomfort associated to non-invasive analgesic techniques | Discomfort associated to non-invasive analgesic techniques. Direct question in the survey in which answer options were each one of the non-invasive analgesic techniques (Cold, VIbration, Anesthetic cream) | 1 hour max | 
| Preference of non-invasive analgesic technique | Preference of non-invasive analgesic technique. Direct question in the survey in which possible answer options were each one of the non-invasive analgesic techniques (Cold, VIbration, Anesthetic cream) | 1 hour max | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Analgesia, Cryoanalgesia, Vibration analgesia, Local anesthetic