Evaluation of pain-alleviating strategies during allergy shots (subcutaneous immunotherapy): a randomized controlled pilot study.

Summary: Background. Subcutaneous immunotherapy (SCIT) is a potential disease-modifying therapy effective for treatment of various allergic disorders. Pain and fear are common concerns of children, which can pose stress and result in negative experiences. The purpose of this study was to evaluate and compare the effectiveness of three marketed distraction devices and ethyl chloride spray (a routinely used topical anesthetic agent for painful procedures), the current clinical standard of care in reducing the perception of needle pain during SCIT administration in children. Methods. 40 children, aged 4-17 years, receiving SCIT with use of one of three alternative pain therapies or with standard practice were enrolled. Participants were randomly assigned to one of the pain-modifying interventions. The three interventional groups were ShotBlocker^® (Bionix, Toledo, OH, USA), Buzzy^® I (Pain Care Labs, Atlanta, GA, USA) (vibration only), and Buzzy^® II (vibration with ice). Control group was ethyl chloride spray. The study consisted of two visits during SCIT administration process. Results. Of these 40 children, 12 received the ShotBlocker, 8 received the Buzzy I, 11 received the Buzzy II, and 9 received ethyl chloride spray (control group). Conclusions. There were no significant differences found between each of the distraction devices and between the control group. Type II error/false negative finding cannot be ruled out because of a small sample. Therefore, we cannot conclude that no true difference exists between each distraction device and the control group simply because of occurrence of a non-significant P-value in our study.