Speed of Injection and Pain During Routine Infant Vaccinations
A Randomized Controlled Trial of Injection Technique for Infant Vaccination
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2015
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 20, 2015
CompletedFirst Posted
Study publicly available on registry
July 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedJuly 23, 2015
July 1, 2015
1.1 years
July 20, 2015
July 22, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Infant Parent-rated Pain Score
up to 2 minutes
Infant Cry duration
up to 2 minutes
Study Arms (2)
Fast injection
EXPERIMENTALVaccine injections will be given at a rate of approximately 2-4 ml/sec by the immunizer
Slow injection
ACTIVE COMPARATORVaccine injections will be given at a rate of approximately 10 ml/sec by the immunizer
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pediatric Consultants
Toronto, Ontario, Canada
Related Publications (1)
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.
PMID: 27527817DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anna Taddio, PhD
University of Toronto
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 20, 2015
First Posted
July 21, 2015
Study Start
July 1, 2015
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
July 23, 2015
Record last verified: 2015-07