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NCT04181632 · ClinicalTrials.gov registry record · NA
Evaluation of Pain Alleviating Strategies During Allergy Shots
A NA study, sponsored by Nemours Children's Clinic.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT04181632: Completed NA study, sponsored by Nemours Children's Clinic.
NCT04181632 is a NA study that has completed, run by Nemours Children's Clinic. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04181632, a NA study, has completed, sponsored by Nemours Children's Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study 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.
Primary Outcome
The change in patient pain perception will be captured utilizing the Wong-Baker FACES (actual faces of happiness or sadness etc. on the scale) Pain Rating Scale (0 no pain - 10 most pain) with each distraction method. The lower score is the better outcome.
Interventions
- DEVICE Buzzy Bee with Ice pack
- DEVICE Buzzy Bee without Ice pack
- DEVICE Shot Blocker
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2019-05-20 |
| Est. Completion | 2020-08-31 |
| Phase | NA |
What the finished NCT04181632 record still lists
NCT04181632 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 3 interventions - of which Buzzy Bee with Ice pack is the first listed.
NCT04181632 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04181632 about?
NCT04181632 is a clinical study titled "Evaluation of Pain Alleviating Strategies During Allergy Shots". 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 pa...
What is the current status of trial NCT04181632?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2019-05-20. Estimated completion is 2020-08-31.
What interventions are being tested in trial NCT04181632?
The interventions under investigation include: Buzzy Bee with Ice pack (DEVICE), Buzzy Bee without Ice pack (DEVICE), Shot Blocker (DEVICE).
Who is sponsoring clinical trial NCT04181632?
This trial is sponsored by Nemours Children's Clinic, which has 108 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04181632's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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