Evaluation of Pain Alleviating Strategies During Allergy Shots (PPAST)

Evaluation of Pain Alleviating Strategies During Allergy Shots (Subcutaneous Immunotherapy): A Randomized Controlled Study (Pain Perception With Allergy Shot Techniques: PPAST)

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.

Study Overview

• Status: Completed
• Conditions: Allergy; Immunotherapy
• Intervention / Treatment: Device: Shot Blocker; Device: Buzzy Bee without Ice pack; Device: Buzzy Bee with Ice pack

Detailed Description

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) Control Group
4. Ethyl Chloride/Pain Ease Spray Number 76-100 (YELLOW)

The three interventional groups are currently marketed distraction devices. The control group is the current clinical standard of care option for pre-allergy injection application.

The study consists of two visits. Both visits will be conducted during the participants routine clinic visit for allergy injections. At the first visit the investigator will assess eligibility. An overview of the study requirements will be provided to parent/child and consent/assent will be obtained.

During the second visit, the child will be randomized to a distraction technique or standard of care group to be utilized with the allergy injection(s) administered at this visit. Adherence with institutional allergy injection guidelines will be maintained. Prior to the application of the distraction method, the investigator will interview the parent to collect data related to demographic information and their child's current allergy health and treatment regime. The child's pain perception will be assessed before and after the allergy injection. The parent's perception of their child's pain will be assessed after the allergy injection. The investigator will provide information on the application of the randomized method and will provide instruction on the completion of the pain scales and questionnaires. The investigator and study staff will not indicate a method preference or guide the child or parent with their pain level responses. After completion of the second visit, the child's study participation is complete.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Nemours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 15 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Shot Blocker; The three interventional groups are currently marketed distraction devices. Arm 1 will be Shot Blocker® Number 1-25 (RED).	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.
No Intervention: Control Group; 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).
Active Comparator: Buzzy I; 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 uses natural pain relief to block needle pain for blood draws and shots. This intervention will be used without an ice pack.
Active Comparator: Buzzy II; 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; Buzzy uses natural pain relief to block needle pain for blood draws and shots. This intervention will be used with an ice pack.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Nemours Children's Clinic

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2019
• Primary Completion (Actual): August 31, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: May 24, 2019
• First Submitted That Met QC Criteria: November 27, 2019
• First Posted (Actual): November 29, 2019

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 9, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: 1353562

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes