Comparison of Different Methods for Reducing Pain From Influenza Vaccine Injections

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01006187
• Other study ID #: 1000014280
• Status: Completed
• Phase: Phase 3
• First received: October 29, 2009
• Last updated: July 18, 2011
• Start date: October 2009
• Est. completion date: November 2009

Study information

• Verified date: July 2011
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 352
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anxiety
• Pain

Intervention

Drug:
• Liposomal lidocaine
4% cream; approximately one gram applied to injection site under an occlusive dressing for 20 minutes prior to injection
• 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
• Distraction
By means of self-selected reading material or video

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain from adult intramuscular influenza virus injection		1 day	No
Secondary	Adverse Events		1 day	Yes
Secondary	Anxiety		1 hour	No