Comparison of Different Methods for Reducing Pain From Influenza Vaccine Injections

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

352 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2009-11-30

Brief Summary

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

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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).

Conditions

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Pain Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group 1

1 liposomal lidocaine 4% cream .

Group Type ACTIVE_COMPARATOR

Liposomal lidocaine

Intervention Type DRUG

4% cream; approximately one gram applied to injection site under an occlusive dressing for 20 minutes prior to injection

Group 2

Vapocoolant spray

Group Type ACTIVE_COMPARATOR

Vapocoolant spray

Intervention Type DRUG

medium stream spray on arm for 4-10 seconds prior to injection

Group 3

Rubbing adjacent to the injection site

Group Type ACTIVE_COMPARATOR

Rubbing adjacent to the injection site

Intervention Type OTHER

rubbing adjacent to the injection site before and during injection

Group 4

Distraction by means of self-selected reading material or internet

Group Type ACTIVE_COMPARATOR

Distraction

Intervention Type OTHER

By means of self-selected reading material or video

Interventions

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Liposomal lidocaine

4% cream; approximately one gram applied to injection site under an occlusive dressing for 20 minutes prior to injection

Intervention Type DRUG

Vapocoolant spray

medium stream spray on arm for 4-10 seconds prior to injection

Intervention Type DRUG

Rubbing adjacent to the injection site

rubbing adjacent to the injection site before and during injection

Intervention Type OTHER

Distraction

By means of self-selected reading material or video

Intervention Type OTHER

Other Intervention Names

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Maxilene™ PainEase™

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes