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Vaccine related pain: Randomized controlled trial of two injection techniques
  1. Moshe Ipp (mm.ipp{at}utoronto.ca)
  1. Hospital for Sick Children, Toronto, Canada
    1. Anna Taddio, Phd (anna.taddio{at}sickkids.ca)
    1. Hospital for Sick Children, Toronto, Canada
      1. Jonathan Sam, Bsc (jonathan.sam{at}utoronto.ca)
      1. University of Toronto, Canada
        1. Morton Goldbach (morty.goldbach{at}utoronto.ca)
        1. Hospital for Sick Children, Toronto, Canada
          1. Patricia C Parkin (patricia.parkin{at}sickkids.ca)
          1. Hospital for Sick Children, Toronto, Canada

            Abstract

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

            Design: Randomized controlled trial.

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

            Subjects: Healthy infants 4 – 6 months of age receiving their routine DPTaP-Hib immunization. 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 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, 6.3) vs. 3.3 (2.6, 3.9). The Standard group was more likely to cry, 47/57 [82%] vs. 24/56 [43%], to cry longer, median [Interquartile Range (IQ)] 14.7 sec (8.7, 35.6) vs. 0 sec (0, 11.30), and to take longer to have the vaccine injected, median (IQ) 8.8 sec (7.9, 10.3) vs. 0.9 sec (0.8, 1.1), p<0.001 for all comparisons. The median (IQ) 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: Immunization using a Pragmatic rapid injection technique is less painful than a slow Standard of care technique and should be recommended for routine intramuscular immunizations.

            • immunization
            • injection speed
            • intramuscular
            • needle aspiration
            • pain

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            • Legends:

              35: Injection without aspiration. Parental/guardian informed consent was obtained for the publication of this video.

              44 Injection with aspiration. Parental/guardian informed consent was obtained for the publication of this video.

              49 Injection without aspiration. Parental/guardian informed consent was obtained for the publication of this video.

              52 Injection with aspiration. Parental/guardian informed consent was obtained for the publication of this video.

              54 Injection without aspiration. Parental/guardian informed consent was obtained for the publication of this video.

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