N/A
N=40
Evaluation of Pain Alleviating Strategies During Allergy Shots
Immunotherapy · Allergy
Bottom Line
View on ClinicalTrials.gov: NCT04181632 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: Change in Patient Pain Perception Utilizing Three Non-pharmacological Pain Control / Distraction Devices and Ethyl Chloride Spray — 1.33; 2.22; 2.25; 1.45 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Buzzy Bee with Ice pack (Device); Buzzy Bee without Ice pack (Device); Shot Blocker (Device)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Nemours Children's Clinic
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Patient Pain Perception Utilizing Three Non-pharmacological Pain Control / Distraction Devices and Ethyl Chloride Spray |
1.33; 2.22; 2.25; 1.45 | — |
Summary
Subcutaneous Immunotherapy (allergy injections) is a potentially disease-modifying therapy that is effective for the treatment of allergic rhinitis/conjunctivitis, allergic asthma and stinging insect hypersensitivity. Pain, which results from the irritation of nearby nerves is a common concern of patients, particularly in children, during or after the injections. This can be a stressful and negative experience for the children. There are various techniques available to minimize pain in general. However, there is a lack of published research on how to use these techniques in children receiving allergy injections. The purpose of this study is to evaluate and compare the efficacy of the standard of care method (Ethyl Chloride/Pain Ease Spray) and three non-pharmacological pain control devices (Buzzy Bee® I, Buzzy Bee II and Shot Blocke®r) in decreasing the perception of pain during subcutaneous allergy injection in a pediatric allergy/immunology clinic setting.
Eligibility Criteria
Inclusion Criteria
- Children aged 4-17 years on injection immunotherapy
- A minimum of three allergy injection injections prior to enrollment at Visit 1
- Child accompanied by parent or legal guardian
Exclusion Criteria
- Children with a known pain or sensory disorders
- Developmental delays lacking necessary cognitive ability
- Administration of any form of pain analgesic within eight hours of randomization at Visit 2
Data sourced from ClinicalTrials.gov (NCT04181632). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.