A Randomised Controlled Trial of Ice to Reduce the Pain of Immunisation—The ICE Trial

Abstract

Background and objectives: vaccine injections are a common cause of iatrogenic pain and anxiety, contributing to non-compliance with scheduled vaccinations. With injection-related pain being recognised as a barrier to vaccination uptake in both adults and children, it is important to investigate strategies to effectively reduce immunisation pain. This prospective randomised controlled trial investigated the effects of applying an ice pack on vaccine-related pain in adults. Methods: medical students receiving the flu vaccination were randomised to receive an ice pack (intervention) or placebo cold pack (control) at the injection site for 30 s prior to needle insertion. Immediate post-vaccination pain (VAS) and adverse reactions in the proceeding 24 h were recorded. Results: pain scores between the intervention (n = 19) and control groups (n = 16) were not statistically significant (intervention: median pain VAS = 7.00, IQR = 18; control: median pain VAS = 11, IQR = 14 (p = 0.26). There were no significant differences in the number of adverse events between the two groups (site pain p = 0.18; localised swelling (p = 0.67); bruising p = 0.09; erythema p = 0.46). Discussion: ice did not reduce vaccination-related pain compared to cold packs. COVID-19 related restrictions impacted participant recruitment, rendering the study insufficiently powered to draw conclusions about the results.