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Annotated Value Analysis
Annotated Literature Review

References, most recent first

McGinnis K, Murray E, Cherven B, McCracken C, Travers C. Effect of Vibration on Pain Response to Heel Lance: A Pilot Randomized Control Trial. Adv Neonatal Care. 2016 Aug 16.

Joseph D. Rundell BS, Joshua A. Sebag, BA, Tracey C. Vlahovic DPM, Robert W. Herpen DPM Carl Kihm, DPM. Use of an External Vibratory Device as a Pain Management Adjunct for Injections of the Foot and Ankle Temple University, Philadelphia PA Click here to view the PDF

The use of vibratory stimulation via the Buzzy® unit significantly decreased pain compared to cold spray alone, decreasing pain 1.3 points on the NPRS and 1.76 on the WBPFS (p=.022, .030). The authors conclude Buzzy "provided a worthwhile decrease associated with foot and ankle injections... cost effective, user friendly, and well tolerated pain management adjunct."

Joshua A. Sebag, BA, Joseph D. Rundell BS, Tracey C. Vlahovic, DPM, and Robert W. Herpen DPM. The Effect of Vibratory Stimulation on Protective Sensation within the Foot. Temple University, Philadelphia PA Click here to view the PDF

"This study has demonstrated external vibratory sensation is capable of producing a transient diminished sensation (p<.00001).... The ability to reduce sensation and perhaps act on the continuum of pain, while remaining cost effective, makes this a reasonable adjunct in podiatric clinical practice."

Potts, D.,  Davis KF, Fein J.  Reducing Venipuncture Pain using a vibrating cold device.  ENA 2015 Orlando Florida A  http://9442a504ec46d0af13f4-ae956c0e16549e94aa8c7d2fa79aca99.r65.cf1.rackcdn.com//204058-4000px.png

In 224 children undergoing venipuncture who were randomized to Buzzy or LMX4, there was no difference in pain, staff or family acceptance, or phlebotomy success.  IVs with Buzzy took 3.5 minutes, IVs with LMX took 40.5m (P<.0001).

Effect of Buzzy® application on pain and injection satisfaction in adult patients who received intramuscular injection. Melek Şahin et al., J Nurs Care 2015, 4:4 presented at 3rd Euro Nursing Conference July 27-29, 2015 Valencia, Spain n=65. Conclusion: "Buzzy® device was an effective method in decreasing injection pain and in improving post injection satisfaction in adult patients received [sic] IM injection."

Schreiber S, Cozzi G, Rutigliano R, Assandro P, Tubaro M, Cortellazzo Wiel L, Ronfani L, Barbi E.  Analgesia by cooling vibration during venipuncture in children with Cognitive Difficulties.  Acta Paediatr. 2015 Sept 24. http://www.ncbi.nlm.nih.gov/pubmed/26401633
70 children without verbal skills were rated using the Non-Communicating Children’s Pain Checklist – 91.4% had no or mild procedural pain using Buzzy, compared to 61.1% in the no intervention group. (p=0.003)

Moadad N, Kozman K, et al. Distraction Using the BUZZY for Children During an IV Insertion.  J Pediatr Nurs. 2015 Sep 22.
In this randomized control trial (RCT), children between the ages of 4 to 12years were assigned to either an intervention or a control group. The intervention group (n=25) had the "BUZZY" applied during IV insertion while the control group (n=23) did not have the "BUZZY". Pain scores were significantly lower in the "BUZZY" group for children and the nurses. Time to a successful IV insertion did not differ between groups. Gender, age, previous hospitalization, diagnoses and analgesics were all factors associated with the children's pain scores. However, a multiple regression analysis found that only the "BUZZY" remained a significant predictor of pain scores in children.

Kearl YL, Yanger S, Montero S, Morelos-Howard E, Claudius I.  Does Combined Use of the J-tip and Buzzy Device Decrease the Pain of Venipuncture in a Pediatric Population? J Pediatr Nurs.  2015 July 27
In patients 1 month to 21 years, with the J-tip® alone (phase 1), 21% had a pain scale score >3 with venipuncture and 22.3% had a pain scale score >3 with application of the J-tip® itself. With Buzzy + Jtip, (phase 2), 14.2% of patients had a pain scale score >3 with venipuncture and 16.1% had a pain scale score >3 with application of the J-tip® itself. However, the pain reductions with Buzzy did not reach statistical significance.

Bahorski J, Hauber RP et al.  Mitigating procedural pain during venipuncture in a pediatric population. Int J Nurs Stud. 2015 Jun 10. (15)00191-1
Children 18 months to 17 years requiring veni-puncture were randomized to Buzzy vibration only, LMX4, or both.  A 3x4 factorial design was used, evaluating age, ethnicity, sex, and intervention.  For the 173 children participating, CHEOPS and WBFPS ratings of pain relief did not significantly differ between Buzzy and LMX.  For Caucasian children, the combination of Buzzy AND LMX provided improved pain relief compared to either group (p=.006) No difference by age or gender was noted. Per the authors, “mechanical vibration [Buzzy] appears to be as effective as a topical anesthetic in children regardless of age, ethnic group, or sex. It has the advantage of being a fast-acting, cost effective, non-pharmacological preparatory intervention for venipuncture in children.”

Sahiner N, Inal S. The effect of combined stimulation of external cold and vibration during immunization on pain and anxiety levels in children.  J Perianesth Nurs. 2015 Jun;30(3):228-35. 
104 7-year olds receiving the Tdap vaccine received either Buzzy or standard care during the vaccination.  Pain was rated by parents, nurses, and by self-report, with all showing significant pain reduction of 71-75%.  In addition, despite slightly greater initial anxiety in the Buzzy group (often associated with greater reported pain), researchers found anxiety was also reduced by 70% on average during the immunization in the group using Buzzy.

Canbulat N, Ayhan F, Inal S.  Effectiveness of External Cold and Vibration for Procedural Pain Relief During Peripheral Intravenous Cannulation in Pediatric Patients.  Pain Management Nursing, 2015 Feb;16(1):33-9.
The authors describe 176 patients aged 7 to 12 years who were randomized to either a control group that received no cannulation intervention and the experimental group that received external cold and vibration via Buzzy.  The same nurse conducted the peripheral IV cannulation in all children.  Cold and vibration were applied 1 minute before the peripheral IV and continued until the end of the procedure.  Pre-procedural anxiety did not differ.  Comparison of the two groups showed 52-60% pain reduction (p<.001) and significantly lower anxiety levels in the experimental group than in the control group during the peripheral IV cannulation.  “Buzzy can be considered to provide an effective combination of cold and vibration that can be used during pediatric peripheral IV cannulation by pediatric nurses.”

Whelan HM, Kunselman AR et al.  The Impact of a Locally Applied Vibrating Device on Outpatient Venipuncture in Children.  Clin Pediatr 2014 Oct;53(12):1189-95.
As part of a quality improvement project, patients and phlebotomists were surveyed prior to initiation of implementation of the vibrating device Buzzy.  Prior to the device, 17 of 29 children (59%) indicated they wished something had been used to decrease venipuncture pain.  80% of those using the vibrating device (n=35) indicated that they would like it used for future procedures.  Children with previous venipuncture experiences appeared to benefit most.  81% of phlebotomists reported the vibration made the procedure easier; none reported it complicated the procedure.  The study concluded that locally applied vibration appears to be a well-accepted technique to minimize discomfort that may facilitate the procedure.

Russell R. Nicholson, L. Legge, E. Leauanae, A. Olsen, S. Marsh. R. Naidu. Reducing the pain of Bicillin injections in the Rheumatic Fever population of CMDHB. Counties Manukau District Health Board.  J Pediatr Child Health October 18 2013. Pain from 5.36 ->2.44, 54% reduction in injection pain. N=199 p<.001 pain, p=.007 fear reduction.

Inal S, Kelleci M. Buzzy relieves pediatric venipuncture pain during blood specimen collection. MCN Am J Matern Child Nurs 2012 Sep;37(5):339-45.Buzzy alone no distraction: 6.56 -> 2.78, 58% reduction in pain. Fear 52% reduction. N=120 p<.001

Baxter AL, Cohen LL, Von Baeyer C. An Integration of Vibration and Cold Relieves Venipuncture Pain in a Pediatric Emergency Department. Pediatr Emerg Care, 2011 Dec;27(12): 1151-6. Pain reduced by child, parent, and nurse reports median 4 to median 2 = 50%. N=87 p=.005 – p=.036 Improved IV success OR 3.05 (1.03-9.02)

Baxter AL, Leong T, Mathew B. External thermomechanical stimulation versus vapocoolant for adult venipuncture pain : Pilot data on a novel device. Clin J Pain, 2009 October ;25(8):705-10. This was a crossover pilot study of 16 adult patients using Buzzy or nothing and 14 patients using vapocoolant spray or nothing. The Buzzy device prototype significantly reduced pain (p=.035) while vapocoolant spray did not. Those with greater needle anxiety were more likely to experience pain relief with Buzzy: each 20 mm of prior anxiety increased the likelihood of intervention pain relief (odds ratio 2, P=0.043).


Abstract Presentations and Posters

 

Potts D, Davis KF, Fein JA. Venipuncture Pain Reduction Using a Vibrating, Cold Device. ENA Orlando Florida October 2 2015 http://9442a504ec46d0af13f4-ae956c0e16549e94aa8c7d2fa79aca99.r65.cf1.rackcdn.com//204058-4000px.png

Troger, A. Robinson H et al. Helping Children Cope with Discomfort Associated with Skin Prick Testing in a Pediatric Setting: A Quality Improvement Report. J Allergy Clin Immunol 133 (2) 2014:A

Cox J, Salama, et al. Effect of Vibration Cold on Behavior of Children Receiving Local Anesthesia. University of Nebraska College of Dentistry.

Inal S, Kelleci M. External thermomechanical stimulation and distraction are effective on pain relief of children during blood draw. International Nursing Research Conference, Burgos, Spain November 2010. (Abstract) Results: On a 0 to 10 scale, the mean of pain levels during the procedure in the control group was 4.46+/-2.9. It was 1.38+/- 1.3 in the Buzzy group. It was 2.43+/-1.3 in the distraction cards group and 0.53+/-0.9 in the buzzy + cards group. There was a significant difference between all groups’ mean of pain levels during the procedure (F=0.46, P<.05) Summary: Buzzy and DistrACTION® Cards together: 88% decrease of phlebotomy pain adding distraction to Buzzy n=120 Buzzy alone no distraction, 4.46 -> 1.38, 69% reduction in pain N=120

Literature Review – Abstracts and Summaries

Canbulat N, Ayhan F, Inal S. Effectiveness of External Cold and Vibration for Procedural Pain Relief During Peripheral Intravenous Cannulation in Pediatric Patients. Pain Management Nursing, 2014 Jun 6 S1524-9042.
The authors describe 176 patients aged 7 to 12 years who were randomized to either a control group that received no cannulation intervention and the experimental group that received external cold and vibration via Buzzy. The same nurse conducted the peripheral IV cannulation in all children. Cold and vibration were applied 1 minute before the peripheral IV and continued until the end of the procedure. Preprocedural anxiety did not differ. Comparison of the two groups showed significantly lower pain and anxiety levels in the experimental group than in the control group during the peripheral IV cannulation. Buzzy can be considered to provide an effective combination of cold and vibration that can be used during pediatric peripheral IV cannulation by pediatric nurses.
Whelan HM, Kunselman AR et al. The Impact of a Locally Applied Vibrating Device on Outpatient Venipuncture in Children. Clin Pediatr 2014 Jun 12.
As part of a quality improvement project, patients and phlebotomists were surveyed prior to initiation of implementation of the vibrating device Buzzy. Prior to the device, 17 of 29 children (59%) indicated they wished something had been used to decrease venipuncture pain. 80% of those using the vibrating device (n=35) indicated that they would like it used for future procedures. Children with previous venipuncture experiences appeared to benefit most. Phlebotomists reported the vibration made the procedure easier in 81% of the cases; none reported it complicated the procedure. The study concluded that locally applied vibration appears to be a well-accepted technique to minimize discomfort that may facilitate completion of the procedure.
Inal S, Kelleci M. Relief of pain during blood specimen collection in pediatric patients. MCN Am J Matern Child Nursing. 2012 Sep;37(5)339-45.
In this randomized controlled trial, 120 children aged 6 to 12 years underwent phlebotomy, either with no intervention for pain management or using the Buzzy device with cold and vibration throughout the procedure. The experimental group showed significantly lower pain (p< .001) and anxiety levels (p<.001) throughout the blood specimen collection. Authors concluded that Buzzy decreased perceived pain and reduced anxiety throughout blood collection, without decreasing the effectiveness of the procedure.
Baxter AL, Cohen LL et al. An integration of vibration and cold relieves venipuncture pain in a pediatric emergency department. Pediatric Emerg Care 2011 Dec;27(12):1151-6
In this first study of pediatric patients undergoing phlebotomy or IV cannulation in a pediatric emergency department, patients were block randomized by use of LMX or no intervention in triage. When the 4 to 18 year olds were cannulated, they were randomized to Buzzy or cold spray (a proven fast acting pain reliever). In the 81 children, median age 10 years, Buzzy was associated with both lower pain scores than cold spray by self report on the Faces Pain Scale Revised (-2 on 10 point scale), by observer report, and by parent report. Venipuncture success was more likely with Buzzy, OR 3.05; 95%CI 1.03-9.02). Authors concluded that the cold and vibration device significantly decreased pain while improving procedural success over the use of cold spray.
Baxter AL, Leong T, Mathew B. External Thermomechanical stimulation versus vapocoolant for adult venipuncture pain: pilot data on a novel device. Clin J Pain 2009 Oct;25(8):705-10.
This was a crossover pilot study of 16 adult patients using Buzzy or nothing and 14 patients using vapocoolant spray or nothing. Those with greater needle anxiety were more likely to experience pain relief with Buzzy. The Buzzy device prototype significantly reduced pain (p=.035) while vapocoolant spray did not.
Russell K, Nicholson R, Naidu R. Reducing the Pain of Intramuscular Benzathine Penicillin Injections in the Rheumatic Fever (RF) Population of Counties Manukau District Health Board J Paediatri Child Health. 2014 Feb;50(2):112-7.
Benzthine penicillin injection into the gluteal area is painful, and can lead to decreased adherence with rheumatic fever prevention. In this study, 405 RF patients receiving 4 weekly injections were offered lidocaine and/or Buzzy for pain management. Pre and post surveys of pain and fear were included. Overall pain scores were significantly reduced over all four time points. 71% chose an analgesic intervention. After 5 months, 43% continued to use Buzzy. The authors concluded that the pain reduction strategies were popular in this population, decreasing pain and increasing adherence.
PRESENTATION:
Nahai FR. CME Demonstration of Fillers; Lasers and New Technology. State-of-the-Art in Facial Aesthetics, 2014, Atlanta GA.
In these independent sessions, the presenter demonstrated techniques to decrease pain with injections of BTX-A and Fillers. Placement of Buzzy cold wings for 10 seconds, then vibration only in the VI distribution for brow injections and adjacent to mouth and nasolabial fold placement for fillers was demonstrated. 80-90% preference for Buzzy was reported in the presenter’s filler population. Laser use with Buzzy® was reported on one neck port-wine stain treatment of an adolescent with good results.

Lab results using Buzzy the same as results using standard tourniquet.
Data comparing free-flow blood collection to evaluated prolonged off-label application of Buzzy (2 minute) and prolonged 2 minute application standard tourniquet. No significant differences were found in lab results between Buzzy and standard tourniquet. Note: Prolonged application prior to initiating blood draw is off-label.

Comparison numbers between free-flow transilluminator collection (trans) and Buzzy® left 90 – 180 seconds,(1) and free-flow transilluminator and tourniquet left 90 seconds,(6) with Mean Difference between paired results. Items in bold are statistically significant when compared to free flow, but not with tourniquet use v. Buzzy.

 

Units

Trans

Buzzy®

%Diff

Trans

Tourniquet

%Diff

RBC

(1012/L)

4.80±0.55

4.90±0.55

2.0

4.68(0.45

4.81(0.46)

2.8

Hb

(g/L)

137.9±12.7

141.4±13.2

2.5

14.1(1.4)

14.6(1.4)

2.6

Hct

(%)

40.6±4.0

41.5±4.0

2.2

41.7(4)

42.9(4)

2.9

MCV

(fL)

84.4 (81.8-88.3)

84.6 (81.9-88.1)

0.2

88(5)

89(5)

1.1

RDW

(%)

12.7±0.5

12.7±0.6

0

 

 

 

WBC

(109/L)

7.35±1.94

7.10±1.89

-3.5

6.59(1.87)

6.9(2.02)

4.8

Neu

(106/L)

4.27±1.57

4.15±1.49

-2.9

3.72(1.31)

3.87 (1.4)

4.2

Lymp

(106/L)

2.41±0.80

2.32±0.80

-3.9

2.23(0.73)

2.29(0.75)

2.6

Mono

(106/L)

0.29±0.08

0.28±0.05

-3.6

0.33(0.11)

0.34(0.13)

3.9

Eos

(106/L)

0.16±008

0.16±0.07

0

0.30(.34)

0.37(0.36)

24.1

Baso

(106/L)

0.046±0.02

0.041±0.02

-12.2

0.026(0.02)

0.021(0.02)

23.8

Plt

(109/L)

274±66

272±66

-0.7

200(46)

208(46)

3.6

MPV

(fL)

9.12±0.81

9.09±0.71

-0.3

 

 

 

Legend RBC: red blood cell count; Hct: haematocrit; Hb: haemoglobin concentration, MCV: mean corpuscular volume; MCHC: mean corpuscular haemoglobin content; RDW: red blood cell distribution width; WBC: white blood cell count; NEU: neutrophil count; LYMP: lymphocyte count;MONO: monocyte count; EOS: eosinophil count; BASO: basophil count; PLT: platelet count; MPV: mean platelet volume.

1. Baxter AL, Lawson ML Concerns with the methodology, analysis and discussion of the Buzzy® and transillumination comparison article. Blood Transfus. 2014 Jan;12 Suppl 1:s3-5
2. Baxter AL, Lawson ML. Methodological concerns comparing buzzy to transilluminator device.
Indian J Clin Biochem. 2014 Jan;29(1):114-5.

Ongoing Independent Research
MMJ Labs has never funded research. All research is independent or grant funded. These are independent clinical trials. If your research is not available on ClinicalTrials.gov, please let us know in order to support investigators and avoid duplication of research efforts.
1) Vibrating Cold Device v. LMX4 for IV access NCT01394250 (COMPLETED)
2) Pain Perception of Children and Youth Receiving Non-sedated Botulinum Toxin-A Injections Using the Buzzy® NCT02273284 (Recruiting)
3) Buzzy to decrease the pain of propofol (Recruiting)
4) Buzzy v. Shotblocker for diabetes injections (Recruiting)
5) Buzzy v. Cold Spray for cortisone injections in feet (Recruiting)
6) Buzzy v. Standard Care for Plantar Fasciitis pain and disability (Pre-enrollment)


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