Comparison of Different Methods for Reducing Pain From Influenza Vaccine Injections

Sponsor

The Hospital for Sick Children (Other)

Overall Status

Completed

CT.gov ID

NCT01006187

Collaborator

(none)

352

Enrollment

Location

Arms

Duration (Months)

345.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pain Anxiety	Drug: Liposomal lidocaine Drug: Vapocoolant spray Other: Rubbing adjacent to the injection site Other: Distraction	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

352 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Oct 1, 2009

Actual Primary Completion Date :

Nov 1, 2009

Actual Study Completion Date :

Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1 1 liposomal lidocaine 4% cream .	Drug: Liposomal lidocaine 4% cream; approximately one gram applied to injection site under an occlusive dressing for 20 minutes prior to injection Other Names: Maxilene™
Active Comparator: Group 2 Vapocoolant spray	Drug: Vapocoolant spray medium stream spray on arm for 4-10 seconds prior to injection Other Names: PainEase™
Active Comparator: Group 3 Rubbing adjacent to the injection site	Other: Rubbing adjacent to the injection site rubbing adjacent to the injection site before and during injection
Active Comparator: Group 4 Distraction by means of self-selected reading material or internet	Other: Distraction By means of self-selected reading material or video

Outcome Measures

Primary Outcome Measures

Pain from adult intramuscular influenza virus injection [1 day]

Secondary Outcome Measures

Adverse Events [1 day]
Anxiety [1 hour]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).