Comparison of Different Methods for Reducing Pain From Influenza Vaccine Injections

July 18, 2011 updated by: The Hospital for Sick Children

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

352

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • The Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain from adult intramuscular influenza virus injection
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse Events
Time Frame: 1 day
1 day
Anxiety
Time Frame: 1 hour
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Investigators

  • Principal Investigator: Anna Taddio, PhD, The Hospital for Sick Children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

October 29, 2009

First Submitted That Met QC Criteria

October 29, 2009

First Posted (Estimate)

November 1, 2009

Study Record Updates

Last Update Posted (Estimate)

July 19, 2011

Last Update Submitted That Met QC Criteria

July 18, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000014280

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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