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Evaluation of pain-alleviating strategies during allergy shots (subcutaneous immunotherapy): a randomized controlled
J Pfieffer1, K Wehmeier1, K Gee1
1Division of Allergy and Clinical Immunology, Nemours Children's Health, Jacksonville (FL), U.S.A.
Insights
This study found no significant difference in pain reduction between distraction devices (ShotBlocker, Buzzy I, Buzzy II) and ethyl chloride spray during subcutaneous immunotherapy (SCIT) in children. A small sample size limits definitive conclusions about these needle pain interventions.
Area of Science:
- Pediatric Allergy and Immunology
- Pain Management in Children
- Medical Device Evaluation
Background:
- Subcutaneous immunotherapy (SCIT) is a disease-modifying treatment for allergic disorders.
- Children often experience pain and fear during SCIT, leading to stress and negative experiences.
- Effective pain management strategies are crucial for adherence and positive patient outcomes.
Purpose of the Study:
- To compare the effectiveness of three distraction devices against ethyl chloride spray for reducing needle pain during SCIT in children.
- To evaluate the potential of marketed distraction devices as alternatives to standard topical anesthetic care.
- To assess the impact of different pain-reducing interventions on children's perception of pain during SCIT.
Main Methods:
- A randomized study involving 40 children (aged 4-17 years) undergoing SCIT.
- Participants were assigned to receive pain management via ShotBlocker, Buzzy I (vibration), Buzzy II (vibration with ice), or ethyl chloride spray (control).
- Pain perception was assessed during two SCIT administration visits.
Main Results:
- 12 children used ShotBlocker, 8 used Buzzy I, 11 used Buzzy II, and 9 received ethyl chloride spray.
- No statistically significant differences in pain reduction were observed between any of the distraction devices and the control group.
- The study was limited by a small sample size, potentially leading to a false negative finding (Type II error).
Conclusions:
- Current evidence does not support a significant difference in needle pain reduction among the tested distraction devices and ethyl chloride spray for SCIT in children.
- The non-significant findings may be due to insufficient statistical power from the small sample size.
- Further research with larger cohorts is needed to definitively determine the efficacy of these pain-reducing interventions in pediatric SCIT.
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.
