Comparison of Different Methods for Reducing Pain From Influenza Vaccine Injections

Phase 3

Completed

• Conditions: Pain; Anxiety
• Interventions: Drug: Liposomal lidocaine; Drug: Vapocoolant spray; Other: Rubbing adjacent to the injection site; Other: Distraction

• Registration Number: NCT01006187
• Lead Sponsor: The Hospital for Sick Children

Brief Summary

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

Detailed 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).

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-29
• Study First Submitted QC: 2009-10-29
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Study First Posted: 2009-11-01
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-18
• Last Update Posted: 2011-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 352

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Liposomal lidocaine	1 liposomal lidocaine 4% cream .
Group 2	Vapocoolant spray	Vapocoolant spray
Group 3	Rubbing adjacent to the injection site	Rubbing adjacent to the injection site
Group 4	Distraction	Distraction by means of self-selected reading material or internet

Primary Outcome Measures

Name	Time	Method
Pain from adult intramuscular influenza virus injection	1 day

Secondary Outcome Measures

Name	Time	Method
Adverse Events	1 day
Anxiety	1 hour

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada