NCT02504398

Speed of Injection and Pain During Routine Infant Vaccinations

A Randomized Controlled Trial of Injection Technique for Infant Vaccination

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University of Toronto · Academic / Other
• Sex: All
• Age: 2 Months – 7 Months
• Healthy volunteers: Accepted

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.

Conditions

• Routine Infant Immunizations
• Pain Management

Interventions

Type	Name	Description
OTHER	Fast injection speed by immunizer
OTHER	Slow injection speed by immunizer

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2015-07-21
• Last updated: 2015-07-23

Locations

1 site across 1 country: Canada