A Phase 3 interventional study of Liposomal lidocaine and Vapocoolant spray in Pain and Anxiety, sponsored by The Hospital for Sick Children. Completed at 1 site in Canada. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-07-19.
Sponsored by The Hospital for Sick Children · Phase 3, Interventional, and Prevention
The purpose of this study is to compare four different analgesic strategies in adults undergoing routine influenza immunization
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).
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 352 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →The Hospital for Sick Children is the lead sponsor of 568 studies on the registry; 81 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1 liposomal lidocaine 4% cream .
Drug: Liposomal lidocaine
Vapocoolant spray
Drug: Vapocoolant spray
Rubbing adjacent to the injection site
Other: Rubbing adjacent to the injection site
Distraction by means of self-selected reading material or internet
Other: Distraction
4% cream; approximately one gram applied to injection site under an occlusive dressing for 20 minutes prior to injection
Also known as: Maxilene™
medium stream spray on arm for 4-10 seconds prior to injection
Also known as: PainEase™
rubbing adjacent to the injection site before and during injection
By means of self-selected reading material or video
Pain from adult intramuscular influenza virus injection
Time frame: 1 day
Adverse Events
Time frame: 1 day
Anxiety
Time frame: 1 hour
This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.
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The Hospital for Sick Children