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Evaluation of Pain Alleviating Strategies During Allergy Shots

NCT04181632 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-06-29

Study results available
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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.

Conditions

  • Immunotherapy
  • Allergy

Interventions

DEVICE

Buzzy Bee with Ice pack

Buzzy uses natural pain relief to block needle pain for blood draws and shots. This intervention will be used with an ice pack.

DEVICE

Buzzy Bee without Ice pack

Buzzy uses natural pain relief to block needle pain for blood draws and shots. This intervention will be used without an ice pack.

DEVICE

Shot Blocker

Shot Blocker is a device that instantly alleviates the pain and anxiety of needle injections when pressed firmly against the skin at the injection site.

Sponsors & Collaborators

  • Nemours Children's Clinic

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-20
Primary Completion
2020-08-31
Completion
2020-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04181632 on ClinicalTrials.gov