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Vaccine injections are a significant source of pain for infants. Altering the injection speed when administering vaccines may be an effective intervention and is feasible (cost neutral). At present, there are no data regarding impact of injection speed on vaccine injection pain in infants. The aim of this study is to address this knowledge gap and to compare the impact of slow and fast vaccine injection speeds on pain during routine infant vaccinations.
To date, there has been no evidence-based guidance regarding the rate at which vaccines should be injected to minimize pain. This has led to a disparity in practice. Some vaccinators favour a slow rate of injection (around 8-10 sec/mL) while others prefer a more rapid rate of injection (around 2-4 sec/mL).The slow injection method leads to a longer needle dwelling time with the increased possibility of the needle moving around and causing pain by damaging muscle tissue. Rapid injection, on the other hand, may lead to a sudden distension of muscle tissue, which itself could be painful. Allowing the muscle sufficient time to distend in order to accommodate the vaccine might minimize pain. This study will address the identified knowledge gap by comparing pain in infants undergoing routine vaccinations with a fast vs. slow injection speed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fast injection | Experimental | Vaccine injections will be given at a rate of approximately 2-4 ml/sec by the immunizer |
|
| Slow injection | Active Comparator | Vaccine injections will be given at a rate of approximately 10 ml/sec by the immunizer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fast injection speed by immunizer | Other |
| ||
| Slow injection speed by immunizer |
| Measure | Description | Time Frame |
|---|---|---|
| Infant Behavioural Pain Score | Assessed using the Modified Behavioural Pain Scale (0-10) from videotapes of the procedure | up to 1 minute post-vaccinations |
| Measure | Description | Time Frame |
|---|---|---|
| Infant Parent-rated Pain Score | Assessed using a Numerical Rating Scale (0-10) by parent in real time | up to 2 minutes |
| Infant Cry duration | Assessed in 1 minute intervals for 2 minutes following vaccinations from videotapes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Taddio, PhD | Contact | 416-813-6235 | anna.taddio@utoronto.ca | |
| Moshe Ipp, MD | Contact | 416-416-924-1661 | mm.ipp@utoronto.ca |
| Name | Affiliation | Role |
|---|---|---|
| Anna Taddio, PhD | University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Consultants | Recruiting | Toronto | Ontario | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27527817 | Derived | Taddio A, Wong H, Welkovics B, Ilersich AL, Cole M, Goldbach M, Ipp M. A randomized trial of the effect of vaccine injection speed on acute pain in infants. Vaccine. 2016 Sep 7;34(39):4672-4677. doi: 10.1016/j.vaccine.2016.08.023. Epub 2016 Aug 12. |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Other |
|
| up to 2 minutes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |