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Comparison of Different Methods for Reducing Pain From Influenza Vaccine Injections

Primary Purpose

Pain, Anxiety

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Liposomal lidocaine
Vapocoolant spray
Rubbing adjacent to the injection site
Distraction
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain focused on measuring Analgesics, Influenza, Vapocoolant, vaccination, pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

1 liposomal lidocaine 4% cream .

Vapocoolant spray

Rubbing adjacent to the injection site

Distraction by means of self-selected reading material or internet

Outcomes

Primary Outcome Measures

Pain from adult intramuscular influenza virus injection

Secondary Outcome Measures

Adverse Events
Anxiety

Full Information

First Posted
October 29, 2009
Last Updated
July 18, 2011
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT01006187
Brief Title
Comparison of Different Methods for Reducing Pain From Influenza Vaccine Injections
Official Title
Comparison of Different Analgesic Methods for Reducing Pain From Adult Intramuscular Influenza Virus Vaccine Injection
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Anxiety
Keywords
Analgesics, Influenza, Vapocoolant, vaccination, pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
352 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
1 liposomal lidocaine 4% cream .
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Vapocoolant spray
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
Rubbing adjacent to the injection site
Arm Title
Group 4
Arm Type
Active Comparator
Arm Description
Distraction by means of self-selected reading material or internet
Intervention Type
Drug
Intervention Name(s)
Liposomal lidocaine
Other Intervention Name(s)
Maxilene™
Intervention Description
4% cream; approximately one gram applied to injection site under an occlusive dressing for 20 minutes prior to injection
Intervention Type
Drug
Intervention Name(s)
Vapocoolant spray
Other Intervention Name(s)
PainEase™
Intervention Description
medium stream spray on arm for 4-10 seconds prior to injection
Intervention Type
Other
Intervention Name(s)
Rubbing adjacent to the injection site
Intervention Description
rubbing adjacent to the injection site before and during injection
Intervention Type
Other
Intervention Name(s)
Distraction
Intervention Description
By means of self-selected reading material or video
Primary Outcome Measure Information:
Title
Pain from adult intramuscular influenza virus injection
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Adverse Events
Time Frame
1 day
Title
Anxiety
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Taddio, PhD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
20483194
Citation
Taddio A, Lord A, Hogan ME, Kikuta A, Yiu A, Darra E, Bruinse B, Keogh T, Stephens D. A randomized controlled trial of analgesia during vaccination in adults. Vaccine. 2010 Jul 19;28(32):5365-9. doi: 10.1016/j.vaccine.2010.05.015. Epub 2010 May 16.
Results Reference
derived

Learn more about this trial

Comparison of Different Methods for Reducing Pain From Influenza Vaccine Injections

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