Evaluation of Pain Alleviating Strategies During Allergy Shots

NCT04181632 | Completed Results FDA Device

• 1 other identifier: 1353562
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Patient Pain Perception Utilizing Three Non-pharmacological Pain Control / Distraction Devices and Ethyl Chloride Spray

  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.

  Assessment of pain perception before and within 1 minute after the application of the distraction method and administration of the allergy injection within their 30-minute allergy shot appointment.

Study Arms (4)

Shot Blocker

ACTIVE COMPARATOR

The three interventional groups are currently marketed distraction devices. Arm 1 will be Shot Blocker® Number 1-25 (RED).

Device: Shot Blocker

Control Group

NO INTERVENTION

The control group is the current clinical standard of care option for pre-allergy injection application. Ethyl Chloride/Pain Ease Spray Number 76-100 (YELLOW).

Buzzy I

ACTIVE COMPARATOR

The three interventional groups are currently marketed distraction devices. Arm 2 will be Buzzy® I (vibrating only) Number 26-50 (GREEN).

Device: Buzzy Bee without Ice pack

Buzzy II

ACTIVE COMPARATOR

The three interventional groups are currently marketed distraction devices. Arm 3 will be Buzzy® II (vibrating and ice wings) Number 51-75 (BLUE).

Device: Buzzy Bee with Ice pack

Interventions

Buzzy Bee with Ice pack DEVICE

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

Buzzy II

Buzzy Bee without Ice pack DEVICE

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

Buzzy I

Shot Blocker DEVICE

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.

Shot Blocker

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nemours Children's Clinic: lead

Study Sites (1)

Nemours

Jacksonville, Florida, 32207, United States

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Limitations and Caveats

COVID, decreased enrollment, clinic closed, etc.

Results Point of Contact

• Title: Jennifer Pfieffer
• Organization: Nemours Children's Health System (North Florida/JAX)

jennifer.pfieffer@nemours.org

904 383 0414

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Clinical Nurse Specialist, APRN, and Nurse Manager

Model Details: Study Design and Duration This is a randomized controlled study. Approximately 100 children, age 4 - 17 years, who are currently receiving subcutaneous immunotherapy, will randomly select a blinded envelope which assigns the distraction technique to be utilized during their study participation. There will be 25 envelopes assigned to each study group for a total of 100 envelopes. Each envelope will contain a paper with a colored sticker for the associated group assignment and number sequence. The distribution of group assignment by number sequence and color is as follows: Interventional Groups 1. Shot Blocker® Number 1-25 (RED) 2. Buzzy I® (vibrating only) Number 26-50 (GREEN) 3. Buzzy II® (vibrating and ice wings) Number 51-75 (BLUE) 4. Control Group Ethyl Chloride/Pain Ease Spray Number 76-100 (YELLOW)

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: November 29, 2019
• Study Start: May 20, 2019
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: June 29, 2023
• Results First Posted: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)