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Randomized Controlled Trial Comparative Study
Vaccine-related pain: randomised controlled trial of two injection techniques.
- Moshe Ipp, Anna Taddio, Jonathan Sam, Morton Gladbach, and Patricia C Parkin.
- Division of Pediatric Medicine and Pediatric Outcomes Research Team (PORT), Department of Pediatrics, Faculty of Medicine, University of Toronto, Canada. mm.ipp@utoronto.ca
- Arch. Dis. Child. 2007 Dec 1;92(12):1105-8.
ObjectiveTo compare acute pain response during immunisation in infants using a slow standard of care injection technique versus a rapid pragmatic technique.DesignRandomised controlled trial.SettingSingle-centre, urban paediatric primary care practice.SubjectsHealthy infants 4-6 months of age receiving their routine DPTaP-Hib immunisation.InterventionsStandard of care group: slow aspiration prior to injection, slow injection and slow withdrawal. Pragmatic group: no aspiration, rapid injection and rapid withdrawal.Main Outcome MeasuresImmediate infant pain measured by the Modified Behavior Pain Scale (MBPS), crying and parent/paediatrician visual analogue scale (VAS).Results113 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.ConclusionImmunisation using a pragmatic rapid injection technique is less painful than a slow standard of care technique and should be recommended for routine intramuscular immunisations.
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