Comparison of Different Methods for Reducing Pain From Influenza Vaccine Injections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01006187
Recruitment Status : Completed
First Posted : November 2, 2009
Last Update Posted : July 19, 2011
Information provided by:
The Hospital for Sick Children

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

Condition or disease Intervention/treatment Phase
Pain Anxiety Drug: Liposomal lidocaine Drug: Vapocoolant spray Other: Rubbing adjacent to the injection site Other: Distraction Phase 3

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  (Clinical Trial)
Actual Enrollment : 352 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparison of Different Analgesic Methods for Reducing Pain From Adult Intramuscular Influenza Virus Vaccine Injection
Study Start Date : October 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Flu Flu Shot
Drug Information available for: Lidocaine
U.S. FDA Resources

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 Name: Maxilene™
Active Comparator: Group 2
Vapocoolant spray
Drug: Vapocoolant spray
medium stream spray on arm for 4-10 seconds prior to injection
Other Name: 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

Primary Outcome Measures :
  1. Pain from adult intramuscular influenza virus injection [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 1 day ]
  2. Anxiety [ Time Frame: 1 hour ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01006187

Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada
Sponsors and Collaborators
The Hospital for Sick Children
Principal Investigator: Anna Taddio, PhD The Hospital for Sick Children

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Anna Taddio, The Hospital for Sick Children Identifier: NCT01006187     History of Changes
Other Study ID Numbers: 1000014280
First Posted: November 2, 2009    Key Record Dates
Last Update Posted: July 19, 2011
Last Verified: July 2011

Keywords provided by The Hospital for Sick Children:

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action