Food-Allergic Adolescents at Risk for Anaphylaxis: A Randomized Controlled Study of Supervised Injection to Improve Comfort with Epinephrine Self-Injection.

BACKGROUND: Epinephrine self-injection is a key element in the management of food allergy, yet many adolescents report that they may not be able to use the autoinjector when needed. We hypothesized that supervised self-injection with an empty syringe would increase adolescents' comfort with self-injection. OBJECTIVE: The objective of this study was to examine the effect of supervised self-injection on self- and parent-reported comfort and anxiety during and after clinic visits in a food allergy center. METHODS: Sixty adolescent/parent pairs were randomized to self-injection versus control (education only). The predefined primary outcome was a self-reported comfort level with the injection before versus after the intervention on a Likert scale with scores of 1 (Not at all comfortable) to 10 (Extremely comfortable). The primary outcome was evaluated via within-group and between-group analyses. Secondary outcomes included adolescent and parent reports before versus after the injection, and changes in quality of life (QoL) and anxiety a month later. RESULTS: Self-injection was associated with a significant immediate increase in comfort levels (primary outcome; within-group comparison: mean scores: 6.93 preintervention vs 8.37 postintervention, P < .01; between-group ANOVA: 8.37 vs 6.69, P < .01) and with significant improvements in all other predefined (secondary) measures. On follow-up, QoL improved in 52% of intervention patients as compared with 25% of controls; similar differences were observed for anxiety. Those differences were not statistically significant. CONCLUSIONS: A self-injection (with an empty syringe) procedure in a clinic setting improves adolescents' and parents' comfort level with self-injecting. It may translate into substantial clinical benefits should self-injection be needed.