Speed of Injection and Pain During Routine Infant Vaccinations

University of Toronto

Status and phase: Unknown; Phase 3

Conditions: Routine Infant Immunizations; Pain Management

Treatments: Other: Fast injection speed by immunizer; Other: Slow injection speed by immunizer

Study type: Interventional

Funder types: Other

Identifiers

NCT02504398

31803

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 2 to 7 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

Fast injection

Experimental group

Description:

Vaccine injections will be given at a rate of approximately 2-4 ml/sec by the immunizer

Treatment:

Other: Fast injection speed by immunizer

Slow injection

Active Comparator group

Description:

Vaccine injections will be given at a rate of approximately 10 ml/sec by the immunizer

Treatment:

Other: Slow injection speed by immunizer