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Speed of Injection and Pain During Routine Infant Vaccinations

A Randomized Controlled Trial of Injection Technique for Infant Vaccination

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02504398
Enrollment
120
Registered
2015-07-21
Start date
2015-07-31
Completion date
2016-08-31
Last updated
2015-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Management, Routine Infant Immunizations

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.

Interventions

OTHERFast injection speed by immunizer
OTHERSlow injection speed by immunizer

Sponsors

University of Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
2 Months to 7 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Infant Behavioural Pain Scoreup to 1 minute post-vaccinationsAssessed using the Modified Behavioural Pain Scale (0-10) from videotapes of the procedure

Secondary

MeasureTime frameDescription
Infant Parent-rated Pain Scoreup to 2 minutesAssessed using a Numerical Rating Scale (0-10) by parent in real time
Infant Cry durationup to 2 minutesAssessed in 1 minute intervals for 2 minutes following vaccinations from videotapes

Countries

Canada

Contacts

Primary ContactAnna Taddio, PhD
anna.taddio@utoronto.ca416-813-6235
Backup ContactMoshe Ipp, MD
mm.ipp@utoronto.ca416-416-924-1661

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026