Comparison of Different Methods for Reducing Pain From Influenza Vaccine Injections

Study Overview
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Brief Summary
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The purpose of this study is to compare four different analgesic strategies in adults undergoing routine influenza immunization

Detailed Description
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In this study, we will compare relative effectiveness of 4 analgesic strategies (i.e., topical local anesthetics, vapocoolant spray, tactile stimulation and distraction) in adults undergoing routine immunization in order to provide further evidence of the effectiveness of each intervention and to determine if one method is superior to another. We are not including a 'no treatment' group because we do not wish to subject participants to unnecessary pain when there are available analgesic treatments. Moreover, in the presence of a 'no treatment' group, we cannot rule out a placebo effect for all treatment groups unless we provide a matched placebo for each intervention, which is not feasible. In future studies, we plan to address the added benefit of combining analgesic interventions (i.e., evaluating the effect of a multimodal approach).

Official Title
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Comparison of Different Analgesic Methods for Reducing Pain From Adult Intramuscular Influenza Virus Vaccine Injection

Conditions
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Pain, Anxiety

Intervention / Treatment
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* Drug: Liposomal lidocaine
* Drug: Vapocoolant spray
* Other: Rubbing adjacent to the injection site
* Other: Distraction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults aged >18 years of age undergoing voluntary immunization with influenza virus vaccine Exclusion Criteria: Pre-medication with any of the analgesic interventions in this study, Chronic pain syndromes/conditions Receiving systemic analgesics and sedatives Abnormal circulation (e.g., Raynaud's phenomenon) Allergy/hypersensitivity to amide local anesthetics Allergy to influenza virus vaccine or constituents Prior participation in the trial Inability to understand the VAS If suspected to be pregnant, pregnant or breastfeeding (due to possible treatment with liposomal lidocaine).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>1 liposomal lidocaine 4% cream . | Drug: Liposomal lidocaine<br>* 4% cream; approximately one gram applied to injection site under an occlusive dressing for 20 minutes prior to injection<br>* Other names: Maxilene™;|
| Active Comparator: Group 2<br>Vapocoolant spray | Drug: Vapocoolant spray<br>* medium stream spray on arm for 4-10 seconds prior to injection<br>* Other names: PainEase™;|
| Active Comparator: Group 3<br>Rubbing adjacent to the injection site | Other: Rubbing adjacent to the injection site<br>* rubbing adjacent to the injection site before and during injection<br>|
| Active Comparator: Group 4<br>Distraction by means of self-selected reading material or internet | Other: Distraction<br>* By means of self-selected reading material or video<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain from adult intramuscular influenza virus injection |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  | 1 day | 
| Anxiety |  | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Analgesics, Influenza, Vapocoolant, vaccination, pain