Speed of Injection and Pain During Routine Infant Vaccinations

A Randomized Controlled Trial of Injection Technique for Infant Vaccination

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.

Study Overview

• Status: Unknown
• Conditions: Pain Management; Routine Infant Immunizations
• Intervention / Treatment: Other: Fast injection speed by immunizer; Other: Slow injection speed by immunizer

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • Recruiting
      • Pediatric Consultants
      • Contact: Anna Taddio, PhD; Phone Number: 416-813-6235; Email: anna.taddio@utoronto.ca
      • Contact: Moshe M Ipp, MD; Phone Number: 416-924-1661; Email: mm.ipp@utoronto.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 7 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fast injection; Vaccine injections will be given at a rate of approximately 2-4 ml/sec by the immunizer	Other: Fast injection speed by immunizer
Active Comparator: Slow injection; Vaccine injections will be given at a rate of approximately 10 ml/sec by the immunizer	Other: Slow injection speed by immunizer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant Parent-rated Pain Score	Assessed using a Numerical Rating Scale (0-10) by parent in real time	up to 2 minutes
Infant Cry duration	Assessed in 1 minute intervals for 2 minutes following vaccinations from videotapes	up to 2 minutes

Collaborators and Investigators

• Sponsor: University of Toronto
• Investigators: Principal Investigator: Anna Taddio, PhD, University of Toronto

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Anticipated): August 1, 2016
• Study Completion (Anticipated): August 1, 2016

Study Registration Dates

• First Submitted: July 20, 2015
• First Submitted That Met QC Criteria: July 20, 2015
• First Posted (Estimate): July 21, 2015

Study Record Updates

• Last Update Posted (Estimate): July 23, 2015
• Last Update Submitted That Met QC Criteria: July 22, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Sympathomimetics; Adrenergic Uptake Inhibitors; Methamphetamine
• Other Study ID Numbers: 31803