Comparison of Different Methods for Reducing Pain From Influenza Vaccine Injections

The Hospital for Sick Children

Status and phase: Completed; Phase 3

Conditions: Anxiety; Pain

Treatments: Other: Distraction; Other: Rubbing adjacent to the injection site; Drug: Vapocoolant spray; Drug: Liposomal lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01006187

1000014280

Details and patient eligibility

About

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

Full description

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).

Enrollment: 352 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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352 participants in 4 patient groups

Group 1

Active Comparator group

Description:

1 liposomal lidocaine 4% cream .

Treatment:

Drug: Liposomal lidocaine

Group 2

Active Comparator group

Description:

Vapocoolant spray

Treatment:

Drug: Vapocoolant spray

Group 3

Active Comparator group

Description:

Rubbing adjacent to the injection site

Treatment:

Other: Rubbing adjacent to the injection site

Group 4

Active Comparator group

Description:

Distraction by means of self-selected reading material or internet

Treatment:

Other: Distraction