Skip to main content
OpenTrials
Completed

NCT Number: NCT01006187

Comparison of Different Methods for Reducing Pain From Influenza Vaccine Injections

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Hospital for Sick Children

Toronto, Ontario, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Liposomal Lidocaine

Drug

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

Other names: Maxilene™

Vapocoolant spray

Drug

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

Other names: PainEase™

Rubbing adjacent to the injection site

Other

rubbing adjacent to the injection site before and during injection

Distraction

Other

By means of self-selected reading material or video

Primary outcomes

  1. Pain from adult intramuscular influenza virus injection

    Time frame: 1 day

Secondary outcomes

  1. Adverse Events

    Time frame: 1 day

  2. Anxiety

    Time frame: 1 hour

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Nov 2, 2009
Registry last updated
Jul 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.