Speed of Injection and Pain During Routine Infant Vaccinations

Pain Management Clinical Trial

Official title:

A Randomized Controlled Trial of Injection Technique for Infant Vaccination

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02504398
• Other study ID #: 31803
• Status: Recruiting
• Phase: Phase 3
• First received: July 20, 2015
• Last updated: July 22, 2015
• Start date: July 2015
• Est. completion date: August 2016

Study information

• Verified date: July 2015
• Source: University of Toronto
• Contact: Anna Taddio, PhD
• Phone: 416-813-6235
• Email: anna.taddio[@]utoronto.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Months to 7 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain Management
• Routine Infant Immunizations

Intervention

Other:
• Fast injection speed by immunizer

• Slow injection speed by immunizer

Locations

Country	Name	City	State
Canada	Pediatric Consultants	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infant Behavioural Pain Score	Assessed using the Modified Behavioural Pain Scale (0-10) from videotapes of the procedure	up to 1 minute post-vaccinations	No
Secondary	Infant Parent-rated Pain Score	Assessed using a Numerical Rating Scale (0-10) by parent in real time	up to 2 minutes	No
Secondary	Infant Cry duration	Assessed in 1 minute intervals for 2 minutes following vaccinations from videotapes	up to 2 minutes	No