The Hospital for Sick Children
Toronto, Ontario, Canada
NCT Number: NCT01006187
The purpose of this study is to compare four different analgesic strategies in adults undergoing routine influenza immunization
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Notify Me18 year–80 year
All sexes
Interventional
Phase 3
Toronto, Ontario, Canada
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
4% cream; approximately one gram applied to injection site under an occlusive dressing for 20 minutes prior to injection
Other names: Maxilene™
medium stream spray on arm for 4-10 seconds prior to injection
Other names: PainEase™
rubbing adjacent to the injection site before and during injection
By means of self-selected reading material or video
Time frame: 1 day
Time frame: 1 day
Time frame: 1 hour
The Hospital for Sick Children
Other
Comparison of Different Analgesic Methods for Reducing Pain From Adult Intramuscular Influenza Virus Vaccine Injection
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