NCT01006187

Comparison of Different Methods for Reducing Pain From Influenza Vaccine Injections

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 352 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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).

Conditions

• Pain
• Anxiety

Interventions

Type	Name	Description
DRUG	Liposomal lidocaine	4% cream; approximately one gram applied to injection site under an occlusive dressing for 20 minutes prior to injection
DRUG	Vapocoolant spray	medium stream spray on arm for 4-10 seconds prior to injection
OTHER	Rubbing adjacent to the injection site	rubbing adjacent to the injection site before and during injection
OTHER	Distraction	By means of self-selected reading material or video

Timeline

• Start date: 2009-10-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2009-11-02
• Last updated: 2011-07-19

Locations

1 site across 1 country: Canada