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
1 other identifier
interventional
352
1 country
1
Brief Summary
The purpose of this study is to compare four different analgesic strategies in adults undergoing routine influenza immunization
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 pain
Started Oct 2009
Shorter than P25 for phase_3 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 29, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedFirst Posted
Study publicly available on registry
November 2, 2009
CompletedJuly 19, 2011
July 1, 2011
1 month
October 29, 2009
July 18, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain from adult intramuscular influenza virus injection
1 day
Secondary Outcomes (2)
Adverse Events
1 day
Anxiety
1 hour
Study Arms (4)
Group 1
ACTIVE COMPARATOR1 liposomal lidocaine 4% cream .
Group 2
ACTIVE COMPARATORVapocoolant spray
Group 3
ACTIVE COMPARATORRubbing adjacent to the injection site
Group 4
ACTIVE COMPARATORDistraction by means of self-selected reading material or internet
Interventions
4% cream; approximately one gram applied to injection site under an occlusive dressing for 20 minutes prior to injection
medium stream spray on arm for 4-10 seconds prior to injection
rubbing adjacent to the injection site before and during injection
Eligibility Criteria
You may qualify if:
- Healthy adults aged \>18 years of age undergoing voluntary immunization with influenza virus vaccine
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Hospital for Sick Children
Toronto, Ontario, Canada
Related Publications (1)
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.
PMID: 20483194DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anna Taddio, PhD
The Hospital for Sick Children
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 29, 2009
First Posted
November 2, 2009
Study Start
October 1, 2009
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
July 19, 2011
Record last verified: 2011-07