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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01006187

Enrollment

352

Registered

2009-11-02

Start date

2009-10-31

Completion date

2009-11-30

Last updated

2011-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Anxiety

Keywords

Analgesics, Influenza, Vapocoolant, vaccination, pain

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).

Interventions

DRUGLiposomal lidocaine

4% cream; approximately one gram applied to injection site under an occlusive dressing for 20 minutes prior to injection

DRUGVapocoolant spray

medium stream spray on arm for 4-10 seconds prior to injection

OTHERRubbing adjacent to the injection site

rubbing adjacent to the injection site before and during injection

OTHERDistraction

By means of self-selected reading material or video

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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).

Design outcomes

Primary

Measure	Time frame
Pain from adult intramuscular influenza virus injection	1 day

Secondary

Measure	Time frame
Adverse Events	1 day
Anxiety	1 hour

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026