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Vaccine-related pain: randomised controlled trial of two injection techniques
  1. Moshe Ipp1,
  2. Anna Taddio2,
  3. Jonathan Sam3,
  4. Morton Gladbach4,
  5. Patricia C Parkin1
  1. 1
    Division of Pediatric Medicine and Pediatric Outcomes Research Team (PORT), Department of Pediatrics, Faculty of Medicine, University of Toronto, Canada
  2. 2
    Leslie Dean Faculty of Pharmacy, University of Toronto, Toronto, Canada
  3. 3
    Faculty of Medicine, University of Toronto, Toronto, Canada
  4. 4
    Department of Pediatrics, Division of Pediatric Medicine, The Hospital for Sick Children, Toronto, Canada
  1. Moshe Ipp, Department of Paediatrics, Division of Paediatric Medicine, The Hospital for Sick Children, 555 University Avenue, Toronto, Ontario, Canada M5G 1X8; mm.ipp{at}utoronto.ca

Abstract

Objective: To compare acute pain response during immunisation in infants using a slow standard of care injection technique versus a rapid pragmatic technique.

Design: Randomised controlled trial.

Setting: Single-centre, urban paediatric primary care practice.

Subjects: Healthy infants 4–6 months of age receiving their routine DPTaP-Hib immunisation.

Interventions: Standard of care group: slow aspiration prior to injection, slow injection and slow withdrawal. Pragmatic group: no aspiration, rapid injection and rapid withdrawal.

Main outcome measures: Immediate infant pain measured by the Modified Behavior Pain Scale (MBPS), crying and parent/paediatrician visual analogue scale (VAS).

Results: 113 infants participated; there were no observed differences in age, birth order or prior analgesic use. Mean MBPS scores (95% confidence interval (CI)) were higher (p<0.001) for the standard group compared to the pragmatic group, 5.6 (5 to 6.3) vs 3.3 (2.6 to 3.9). The standard group was more likely to cry, 47/57 (82%) vs 24/56 (43%), to cry longer, median (interquartile range (IQR)) 14.7 s (8.7–35.6) vs 0 s (0–11.30), and to take longer to have the vaccine injected, median (IQR) 8.8 s (7.9–10.3) vs 0.9 s (0.8–1.1), p<0.001 for all comparisons. The median (IQR) VAS scores by parents and paediatricians were higher for the standard group: VAS parent, 3.5 (1.6–5.5) vs 1.9 (0.1–3.1) and VAS paediatrician, 2.8 (2.0–5.1) vs 1.4 (0.2–2.4). There were no adverse events.

Conclusion: Immunisation using a pragmatic rapid injection technique is less painful than a slow standard of care technique and should be recommended for routine intramuscular immunisations.

  • needle aspiration
  • injection speed
  • immunisation
  • pain

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Footnotes

  • Contributions: MI is the guarantor for the paper. MI, AT and PP designed the study protocol. MI and MG enrolled subjects. JS, a student, entered data. AT and PP were responsible for data analysis. All authors contributed to the writing and editing of the manuscript.

  • Competing interests: This study was funded by an unrestricted grant from Sanofi Pasteur, Toronto, Canada. The principal investigator (MI) has received unrestricted grant funding and honoraria in the past from Sanofi Pasteur.

  • Abbreviations:
    DPTaP-Hib
    diphtheria-polio-tetanus-acellular pertussis-Haemophilus influenzae group b
    IQR
    interquartile range
    MBPS
    Modified Behavioral Pain Scale
    VAS
    visual analogue scale

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