Clinical trial NCT02504398: Speed of Injection and Pain During Routine Infant Vaccinations
Official title: A Randomized Controlled Trial of Injection Technique for Infant Vaccination
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Routine Infant Immunizations
Pain Management
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2015-07-21
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Infant Behavioural Pain Score
timeFrame: up to 1 minute post-vaccinations
Secondary outcomes:
measure: Infant Parent-rated Pain Score
timeFrame: up to 2 minutes
measure: Infant Cry duration
timeFrame: up to 2 minutes
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Pediatric Consultants
state: Ontario
Study officials:
affiliation: University of Toronto
name: Anna Taddio, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.