Trial Outcomes & Findings for Evaluation of Pain Alleviating Strategies During Allergy Shots (NCT NCT04181632)

Last Updated: 2023-06-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

40 participants

Primary outcome timeframe

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.

Results posted on

2023-06-29

Participant Flow

Goal was to recruit 100 for sample size; however with COVID - only 40 were enrolled.

Participant milestones

Participant milestones
Measure	Shot Blocker The three interventional groups are currently marketed distraction devices. Arm 1 will be Shot Blocker® Number 1-25 (RED). 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.	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).	Buzzy I The three interventional groups are currently marketed distraction devices. Arm 2 will be Buzzy® I (vibrating only) Number 26-50 (GREEN). 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.	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). 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.
Overall Study STARTED	12	9	8	11
Overall Study COMPLETED	12	9	8	11
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Pain Alleviating Strategies During Allergy Shots

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Shot Blocker n=12 Participants The three interventional groups are currently marketed distraction devices. Arm 1 will be Shot Blocker® Number 1-25 (RED). 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.	Control Group n=9 Participants 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 n=8 Participants The three interventional groups are currently marketed distraction devices. Arm 2 will be Buzzy® I (vibrating only) Number 26-50 (GREEN). 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.	Buzzy II n=11 Participants The three interventional groups are currently marketed distraction devices. Arm 3 will be Buzzy® II (vibrating and ice wings) Number 51-75 (BLUE). 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.	Total n=40 Participants Total of all reporting groups
Age, Customized Age Range	14 years n=5 Participants	14 years n=7 Participants	12 years n=5 Participants	13 years n=4 Participants	13 years n=21 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	8 Participants n=4 Participants	22 Participants n=21 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	18 Participants n=21 Participants
Race/Ethnicity, Customized White	6 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	7 Participants n=4 Participants	22 Participants n=21 Participants
Race/Ethnicity, Customized Black	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	7 Participants n=21 Participants
Race/Ethnicity, Customized Hispanic	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants
Race/Ethnicity, Customized Mixed/Other	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	5 Participants n=21 Participants
Region of Enrollment United States	12 participants n=5 Participants	9 participants n=7 Participants	8 participants n=5 Participants	11 participants n=4 Participants	40 participants n=21 Participants
Pain Perception Before Allergy Shot	0 units on a scale STANDARD_DEVIATION 0 • n=5 Participants	0.22 units on a scale STANDARD_DEVIATION 0.67 • n=7 Participants	0.0 units on a scale STANDARD_DEVIATION 0.0 • n=5 Participants	0 units on a scale STANDARD_DEVIATION 0 • n=4 Participants	0.05 units on a scale STANDARD_DEVIATION 0.32 • n=21 Participants

PRIMARY outcome

Timeframe: 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.

Population: Results A total of 40 children who received SCIT were included in this randomized controlled pilot study. Of these 40 children, 12 received the ShotBlocker, 8 received the Buzzy I, 11 received the Buzzy II, and 9 received ethyl chloride spray (control group). Both the overall needle pain rating by the children after their allergy injection and the overall parental perception of needle pain are displayed by each of the four interventions.

Outcome measures

Outcome measures
Measure	Shot Blocker n=12 Participants The three interventional groups are currently marketed distraction devices. Arm 1 will be Shot Blocker® Number 1-25 (RED). 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.	Control Group n=9 Participants 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 n=8 Participants The three interventional groups are currently marketed distraction devices. Arm 2 will be Buzzy® I (vibrating only) Number 26-50 (GREEN). 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.	Buzzy II n=11 Participants The three interventional groups are currently marketed distraction devices. Arm 3 will be Buzzy® II (vibrating and ice wings) Number 51-75 (BLUE). 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.
Change in Patient Pain Perception Utilizing Three Non-pharmacological Pain Control / Distraction Devices and Ethyl Chloride Spray	1.33 score on a scale Standard Deviation 1.3	2.22 score on a scale Standard Deviation 2.11	2.25 score on a scale Standard Deviation 1.28	1.45 score on a scale Standard Deviation 1.57

Adverse Events

Shot Blocker

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Buzzy I

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Buzzy II

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jennifer Pfieffer

Nemours Children's Health System (North Florida/JAX)

Phone: 904 383 0414

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place