Evaluation of Pain Alleviating Strategies During Allergy Shots (Subcutaneous Immunotherapy): A Randomized Controlled Study (Pain Perception With Allergy Shot Techniques: PPAST)
Phase: NA
Conditions: Immunotherapy, Allergy
Sponsor: Nemours Children's Clinic

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Title: Evaluation of pain alleviating strategies during allergy shots (Subcutaneous 
immunotherapy): A randomized controlled study (Pain Perception with Allergy Shot Techniques:  
PPAST) 
 
Principal Investigator   
• 
Jennifer Pfieffer MSN, APRN, PCNS-BC, CPEN 
 
Co-Investigators 
• 
Karen Gee BSN, RN, CPN 
• 
Kristine Wehmeier BSN, RN, AE-C 
• 
Emily Hoehn BSN, RN, CPN 
• 
Monarie Lacanilao BSN, RN 
• 
Tracy DeSanto BSN, RN, CPN 
• 
Tara Spruill MSN, RN, CPN 
• 
Jamie Thibodeaux BSN, RN, CPN 
• 
Amanda Davis BSN, RN 
Ejaz Yousef MD 
• 
 
Research Coordinators 
• 
Isabel Delgado, BSH 
• 
Elizabeth DeLuca, BSN, RN, CCRC 
• 
Mary Warde, BSN, RN, CCRC 
 
Project Consultant / Data Analyst 
• 
Keith Fishlock MSN,ARNP,PCNS-BC, FNP-BC 
 
Rationale and Purpose 
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 Blocker)  in 
decreasing the perception of pain during subcutaneous allergy injection in a pediatric 
allergy/immunology clinic setting. 
   
Objective 
• 
Evaluate and compare the effectiveness of utilizing various techniques to reduce the 
perception of pain during subcutaneous allergy injections in children 
 
Possible Risks and Benefits  
Risk Assessment 
• 
The risks associated with study participation are consistent with standard of care risks. 
Potential risk for the study participants may be possible allergic reaction/skin irritation 
from the cold spray or ice pack or an increased level of anxiety. 
 

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Benefits Assessment 
• 
The potential benefit associated with this research study includes a better understanding 
of study participant’s response to their assigned distraction technique. This study may 
help identify which technique is more beneficial to use in children receiving 
subcutaneous immunotherapy to decrease the perception of pain and reduce anxiety 
related to immunotherapy treatment. 
 
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®  # 1-25 (RED) 
2. Buzzy I  (vibrating only)  # 26-50  (GREEN) 
3. Buzzy II (vibrating and ice wings)  # 51-75  (BLUE) 
➢ Control Group 
4. Ethyl Chloride/Pain Ease Spray # 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. 
  
Inclusion & Exclusion Criteria 
Inclusion Criteria 
 
• 
Children aged 4-17 years on injection immunotherapy 
• 
A minimum of three allergy injection injections prior to enrollment at Visit 1 

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• 
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 Procedures 
Visit 1:  
Children aged 4-17 years who present to receive their injection(s) in the allergy clinic will be 
screened by the Principal Investigator or Co-Investigator for study inclusion and exclusion 
criteria.  During their routine post-allergy injection 30-minute wait time, the investigator and the 
research coordinator will provide the parent and child with an overview of the study design, the 
risk and benefits assessment and study requirements. The investigator will advise the 
parent/child of the pain analgesic administration exclusion for the randomization visit.  After 
obtaining parental permission and child assent, the child will be considered enrolled in the 
study. A subject ID will be assigned. A visible mark placed on the child’s allergy injection chart 
will indicate the child is ready to be randomized at their next routine allergy injection visit. 
 
Visit 2:  
At a future allergy injection clinic visit the parent and the child will be asked if the child took any 
pain-relieving medicines, like Tylenol or Advil, within eight hours before coming to the clinic. If 
the participant needed this kind of medicine, the allergy shot appointment will be the same as 
before the study. 
 
Study visit 2 will be completed at another routine allergy shot appointment. Preferably the next 
scheduled allergy injection visit. 
 
If the participant did not take any pain relieving medicine within the previous eight hours, visit 2 
will continue. The participants study group assignment will be determined. The envelopes 
identifying the four group assignments will be coded by number and color. The child will be 
presented with a basket containing all the envelopes. The investigator will instruct the child to 
select one envelope from the basket.  The envelope selected at random by the child will 
determine the distraction method to be utilized prior to the allergy injection(s).  The possible 
group assignments, one of three currently marketed distraction devices or the control group 
utilizing the current standard of care option, are listed below and are further detailed in 
Attachments I – III.   
 
The four study groups are:   
➢ Interventional Groups 
1. Shot Blocker®  
2. Buzzy I  (with ice pack-wings) 
3. Buzzy II (without ice pack-wings) 
➢ Control Group 
4. Ethyl Chloride/Pain Ease Spray 
 
 

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Before applying the assigned distraction method: 
- 
Prior to randomization, the investigator will interview the parent to obtain the information 
needed to complete the Parent Demographic-Health-Treatment Questionnaire 
(Attachment V).  The investigator will review the responses for any indicator of study 
ineligibility, ie, analgesic medication window.   
- 
The investigator or study staff will review the Wong-Baker FACES Pain Rating Scale 
with the child. The child will be given a Wong-Baker FACES Pain Rating Scale form and 
asked to circle the face which most closely matches their current level of pain awareness 
prior to any intervention. (Attachment IV-a) 
- 
The investigator or study staff will review the Numeric Pain Rating Scale (Attachment IV-
b) with the parent. The parent will be instructed to circle the number on the scale which 
most closely matches their perception of their child’s pain level immediately after 
receiving the allergy injection.  
Application of the distraction method and administration of the allergy injection: 
- 
The investigator will apply the assigned distraction method per method specifications to 
the injection site area (subcutaneous region of the back of the upper arm).  
- 
The investigator will administer the subcutaneous allergy injection(s) within the time 
frame specified for the assigned distraction device utilized or per the standard of care 
guidelines for the Pain Ease Spray, as appropriate.   If the child’s treatment plan 
includes more than one injection, the assigned group technique will be utilized for all 
injections at the visit.   
Post allergy injection procedures: 
- 
Immediately following the allergy injection, the child will be provided with a second 
Wong-Baker FACES Pain Rating Scale form and be asked to circle the face which most 
closely matches their post-injection level of pain awareness. 
- 
Immediately following the allergy injection, the parent will be reminded to circle the 
number on the Numeric Pain Rating Scale which most closely matches their perception 
of the child’s post-injection pain level.   
- 
The participant and parent will then complete the routine 30 minute wait time for post 
allergy injections.  
 
Study participation is complete at the end of Visit 2.  
 
Prohibited Medications 
Analgesic medications administered within eight hours of Visit 2 are prohibited.  
 
Adverse Event (AE) 
An AE is any unfavorable and unintended sign, symptom temporally associated with the use of 
the study technique and does not imply judgment about causality.  
 
AE’s associated with the randomized intervention will be collected at Visit 2. The AE’s 
relationship to the distraction technique will be assessed using the following guidelines for 
causality and grading severity. AE’s related to the allergy injection will not be captured in this 
study. 
 
 
 

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 AE Relationship to Study Distraction Technique Guide 
Relationship to Study 
Distraction Technique 
Comment 
Definitely 
An event that follows a reasonable temporal sequence from 
administration of the study distraction technique; that follows 
a known or expected response pattern to the suspected 
study distraction technique; that is confirmed by stopping the 
use of the study distraction technique; and this is not 
explained by any other reasonable hypothesis. 
Probably 
An event that follows a reasonable temporal sequence from 
administration of the study distraction technique; that follows 
a known or expected response pattern to the suspected 
study technique; that is confirmed by stopping the use of the 
study distraction technique; and that is unlikely to be 
explained by the known characteristics of the subject’s 
clinical state or by other interventions. 
Possibly 
An event that follows a reasonable temporal sequence from 
administration of the study distraction technique; that follows 
a known or expected response pattern to that suspected 
study distraction technique.; but that could readily have 
been produced by a number of other factors. 
Unrelated 
An event that can be determined with certainty to have no 
relationship to the study distraction technique. 
 
AE Severity Grading 
Severity (Toxicity Grade) 
Description  
Mild (1) 
Mild; asymptomatic or mild symptoms; clinical or diagnostic 
observations only; intervention not indicated 
Moderate (2) 
Moderate; minimal, local or noninvasive intervention 
indicated; limiting age-appropriate Instrumental activities of 
daily living (e.g., preparing meals, using the telephone, 
managing money) 
Severe (3) 
Severe or medically significant but not immediately life 
threatening; hospitalization or prolongation of hospitalization 
indicated; disabling; limiting self-care activities of daily living 
(e.g., bathing, dressing, feeding self, using toilet, taking 
medications) 
 
Discontinuation and Replacement of study participants 
A child has the right to withdraw from study participation prior to the completion of Visit 2.  Early 
withdrawal participants will be replaced one to one.   
 
Participant ID assignment 
The study participants will receive a Participant ID at Visit 1 which will be used for all data 
collection. The Participant ID used will range from 001 to 100.  If a study participant withdraws 
before the completion of Visit 2, the Participant and associated group assignment will be 
replaced. Replacement Participant ID’s will be sequential beginning with the number 101.  
 
 

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Data Collection 
Medication administration data collected will be limited to the participant’s current 
immunotherapy vial and dosing, distraction method utilized, site of the application method and, if 
applicable, antihistamine use and pain medication use. Demographic data collected will be age, 
race and gender. Symptom and health data point collection will target allergy injection reactions 
and the presence of allergic rhinitis, asthma and atopic dermatitis. (Refer to Attachment V).   
Pain perception data will be collected from both the child and parent using facial and numeric 
pain scales (Refer to Attachment IV).   
All data collected will be entered into an EXCEL data collection tool and stored on password 
protected, secure computers.  The data will accessible only to the investigators and research 
coordinators in the study. 
 
Data Analysis 
Quantitative component data collected and evaluated for this study will include the number of 
patient participants within the allergy department, randomized interventions used, diagnoses 
including allergic rhinitis, asthma and atopic dermatitis, immunotherapy medication and dose, 
antihistamine and pain medication utilization, patient and parental pain scores, adverse 
reactions, age, race, and gender.  
Quantitative component data collected for this study will be extracted into Microsoft Excel 
spreadsheets and analyzed using Excel functions. Target population demographic 
characteristics will be analyzed using descriptive statistics by the principal investigator with the 
level of significance set at <0.05.  
 All information collected as part of evaluating the impact of this study will be aggregated data 
from the project participants and will not include any potential patient identifiers.  Participant 
confidentiality will be assured by coding the participants using individual identification numbers 
for any analysis activities occurring outside of the electronic health record. This information will 
be stored in accordance with Nemours IRB policies and procedures.  The Excel files containing 
codified data without protected health information (PHI) will be stored in password protected 
files at Nemours, on a password protected desktop computer in a locked office space 
accessible only by the principal investigator and study designees. The risk to patients 
participating in this project will be no different from the risks of patients receiving standard care. 
 
Informed Consent Process 
• 
Children who meet study criteria will be identified by Principal Investigator or Co-
Investigator in the allergy clinic.   
• 
Parents/guardians and child will be given an overview of the study, participation 
requirements, and complete information on being a voluntary participant in a 
research study.  They will be given an opportunity to read the consent form, have 
questions answered and decide if they want their child to participate.   
• 
If both the parent and child are interested in participating in the study, one 
parent/legal guardian will be asked to sign a Parental Permission and Consent Form.  
• 
Children between the ages of 7 and 17 who verbalize understanding and are 
agreeable to the Assent information and study expectations will be asked to sign a 
Child Assent or Adolescent Assent Form. 
• 
The Principal Investigator, Co-Investigator or Research Coordinator obtaining 
consent will witness the parent and child signatures, will sign both documents and 
provide copies of the signed consent/assent to the parent and child. 

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Participating Sites 
The study will be conducted at Nemours Children’s Specialty Care in the pediatric allergy clinics 
locations: 
• 
Jacksonville Downtown  
• 
Jacksonville South  
• 
Fleming Island  
 
Literature Cited  
Angela Li, Zorash Montaño, Vincent J Chen, and Jeffrey I Gold :Virtual reality and pain 
management: current trends and future Directions:; Pain Manag. 2011 March ; 1(2): 147–157 
Rasha Srouji, Savithiri Ratnapalan, and Suzan Schneeweiss:Pain in Children: Assessment and 
Nonpharmacological Management.. International Journal of Pediatrics; Volume 2010 
Psychological interventions for needle‐related procedural pain and distress in children and 
adolescents:Cochrane Systematic Review - Intervention Version published: 04 October 2018 
Ariane Ballard,2 Christelle Khadra, Samara Adler, Evelyne Doyon-Trottier, and Sylvie Le 
May:Efficacy of the Buzzy® device for pain management of children during needle-related 
procedures: a systematic review protocol:;Syst Rev. 2018; 7: 78.  
Shomaker K, Dutton S, Mark M. Pain prevalence and treatment patterns in a US children's 
hospital. Hosp Pediatr 2015;5:363–7. 
Stevens BJ, Yamada J, Estabrooks CA, Stinson J, Campbell F, Scott SD, Cummings G; CIHR 
Team in Children's Pain. Pain in hospitalized children: effect of a multidimensional knowledge 
translation strategy on pain process and clinical outcomes. PAIN 2014;155:60–8. 
 
Vessey JA, Carlson KL, McGill J. Use of distraction with children during an acute pain 
experience. Nursing Research. 1994;43(6):369–372 
Cohen LL, Blount RL, Cohen RJ, Schaen ER, Zaff JF. Comparative study of distraction versus 
topical anesthesia for pediatric pain management during immunizations. Health Psychology. 
1999;18(6):591–598. 
 
 
 
 
 
 
 
 
Attachments: 

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I – Shot Blocker
 

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II – Buzzy Bee I (with ice pack-wings) and Buzzy Bee II (without ice pack-wings) 
    
 

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III – Ethyl chloride spray 
 
 

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IV – Data Collection Instruments for pain rating scales – (a) facial (b) numeric 
 
  

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V – Parent Questionnaire: Demographic – Health – Treatment Questionnaire