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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | 1 liposomal lidocaine 4% cream . |
|
| Group 2 | Active Comparator | Vapocoolant spray |
|
| Group 3 | Active Comparator | Rubbing adjacent to the injection site |
|
| Group 4 | Active Comparator | Distraction by means of self-selected reading material or internet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal lidocaine | Drug | 4% cream; approximately one gram applied to injection site under an occlusive dressing for 20 minutes prior to injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain from adult intramuscular influenza virus injection | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | 1 day | |
| Anxiety | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Taddio, PhD | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20483194 | Derived | 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. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C114888 | Maxilene |
| D019857 | Osteogenesis, Distraction |
| ID | Term |
|---|---|
| D001852 | Bone Lengthening |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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| Vapocoolant spray | Drug | medium stream spray on arm for 4-10 seconds prior to injection |
|
|
| Rubbing adjacent to the injection site | Other | rubbing adjacent to the injection site before and during injection |
|
| Distraction | Other | By means of self-selected reading material or video |
|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |