Speed of Injection and Pain During Routine Infant Vaccinations
Information source: University of Toronto
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Routine Infant Immunizations; Pain Management
Intervention: Fast injection speed by immunizer (Other); Slow injection speed by immunizer (Other)
Phase: Phase 3
Status: Recruiting
Sponsored by: University of Toronto Official(s) and/or principal investigator(s): Anna Taddio, PhD, Principal Investigator, Affiliation: University of Toronto
Overall contact: Anna Taddio, PhD, Phone: 416-813-6235, Email: anna.taddio@utoronto.ca
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.
Clinical Details
Official title: A Randomized Controlled Trial of Injection Technique for Infant Vaccination
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Infant Behavioural Pain Score
Secondary outcome: Infant Parent-rated Pain ScoreInfant Cry duration
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
Minimum age: 2 Months.
Maximum age: 7 Months.
Gender(s): Both.
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
Locations and Contacts
Anna Taddio, PhD, Phone: 416-813-6235, Email: anna.taddio@utoronto.ca
Pediatric Consultants, Toronto, Ontario, Canada; Recruiting Moshe M Ipp, MD, Phone: 416-924-1661, Email: mm.ipp@utoronto.ca Anna Taddio, PhD, Phone: 416-813-6235, Email: anna.taddio@utoronto.ca
Additional Information
Starting date: July 2015
Last updated: July 22, 2015
|