Background and aims: The multiplicity of vaccine injections during childhood leads to iterative painful and stressful experiences which may lead in turn to anticipated pain and then possibly to a true needle phobia. We aimed at evaluating a multifactorial strategy of pain management combining pharmacological and non-pharmacological approaches during vaccination, as compared to usual care, in 4- to 12-year-old children.
Methods: In all, 239 children were enrolled by 25 family practitioners in an open-label study. After a pseudo-randomization, usual pain management (n = 132) was compared to a multifactorial strategy (n = 107) associating preliminary application of an anesthesic patch, preferential use of specified vaccines, child education by the parents and the doctor, parental accompaniment and child distraction with soap bubbles during the procedure. The primary outcome (i.e. child pain) was assessed with a self-report scale named visual analog scale (VAS) of pain.
Results: A significant decrease in pain was obtained using the multifactorial strategy, as assessed by self-reported VAS (P < 0.0001). This was confirmed by another self-report scale (the facial pain scale revised: P = 0.005), as well as with hetero-evaluations by GPs and parents [Children's Hospital of Eastern Ontario Pain Scale: P = 0.0007; GPs VAS (P < 0.0001), parents VAS (P < 0.0001)], which were secondary outcome criteria.
Conclusions: This multifactorial method significantly decreases vaccination pain in 4- to 12-year-old children. This strategy could make vaccines more acceptable to children and may improve child-doctor relationships and contribute to a decrease in child fear about health care.