Speed of Injection and Pain During Routine Infant Vaccinations

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Controlled Trial of Injection Technique for Infant Vaccination

Conditions
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Routine Infant Immunizations, Pain Management

Intervention / Treatment
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* Other: Fast injection speed by immunizer
* Other: Slow injection speed by immunizer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy 2 and 4 month old infants receiving their primary vaccine injections, PediacelTM (0.5mL) and PrevnarTM (0.5mL) (in conjunction with and preceded by oral RotarixTM vaccine) and healthy 6 month old infants receiving their routine vaccine injection, PediacelTM (0.5mL) Exclusion Criteria: Infants with impaired neurological development; history of seizures; administration of sedatives or narcotics in the preceding 24 hours; parental inability to use study tools; parent vaccine refusal; prior participation in the trial; and refusal to be video recorded

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 7 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fast injection<br>Vaccine injections will be given at a rate of approximately 2-4 ml/sec by the immunizer | Other: Fast injection speed by immunizer<br> <br> |
| Active Comparator: Slow injection<br>Vaccine injections will be given at a rate of approximately 10 ml/sec by the immunizer | Other: Slow injection speed by immunizer<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | up to 2 minutes |