Comparison of Different Methods for Reducing Pain From Influenza Vaccine Injections

This study has been completed.
Sponsor:
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01006187
First received: October 29, 2009
Last updated: July 18, 2011
Last verified: July 2011
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Comparison of Different Analgesic Methods for Reducing Pain From Adult Intramuscular Influenza Virus Vaccine Injection

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Pain from adult intramuscular influenza virus injection [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse Events [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
  • Anxiety [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Enrollment: 352
Study Start Date: October 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01006187

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

No publications provided by The Hospital for Sick Children

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Anna Taddio, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01006187     History of Changes
Other Study ID Numbers: 1000014280
Study First Received: October 29, 2009
Last Updated: July 18, 2011
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
Analgesics
Influenza
Vapocoolant
vaccination
pain

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

ClinicalTrials.gov processed this record on August 26, 2014