Comparison of Different Analgesic Methods for Reducing Pain From Adult Intramuscular Influenza Virus Vaccine Injection
Overview
- Phase
- Phase 3
- Intervention
- Liposomal lidocaine
- Conditions
- Pain
- Sponsor
- The Hospital for Sick Children
- Enrollment
- 352
- Locations
- 1
- Primary Endpoint
- Pain from adult intramuscular influenza virus injection
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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).
Investigators
Eligibility Criteria
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).
Arms & Interventions
Group 1
1 liposomal lidocaine 4% cream .
Intervention: Liposomal lidocaine
Group 2
Vapocoolant spray
Intervention: Vapocoolant spray
Group 3
Rubbing adjacent to the injection site
Intervention: Rubbing adjacent to the injection site
Group 4
Distraction by means of self-selected reading material or internet
Intervention: Distraction
Outcomes
Primary Outcomes
Pain from adult intramuscular influenza virus injection
Time Frame: 1 day
Secondary Outcomes
- Adverse Events(1 day)
- Anxiety(1 hour)