ORIGINAL ARTICLE

An Integration of Vibration and Cold Relieves Venipuncture

Pain in a Pediatric Emergency Department
Amy L. Baxter, MD,* Lindsey L. Cohen, PhD, Heather L. McElvery, RN,
Mona Louise Lawson, PhD,|| and Carl L. von Baeyer, PhD

Objective: A randomized controlled trial compared a reusable device combining cold and vibration to standard care for pediatric venous
access pain relief.
Methods: Pediatric emergency department patients received either the
cold vibration device placed 5 to 10 cm proximally throughout venipuncture or standard care control (primarily vapocoolant spray). Block
randomization of patients with or without lidocaine cream already in
place ensured equal allocation in both intervention groups. Pain was
measured via self- and parent-report using the 0- to 10-point Faces Pain
ScaleYRevised and with coded videotaped observed behaviors. Venipuncture success, use of distraction, and access times were also assessed.
Results: Eighty-one 4- to 18-year-olds were randomized to the device
(n = 41) or standard care (n = 40) (median age, 10.09 years; 95% confidence interval [95% CI], 8.91Y10.89). Median patient-reported pain
scores with the device were lower than with standard care (j2; 95%
CI, j4 to 0), as were parent-assessed pain scores (j2; 95% CI, j4
to j2). Observed distress behaviors were more common with standard care (2; 95% CI, 1Y3) than with the device (1; 95% CI, 0Y2).
Venipuncture success was more likely with the device (odds ratio, 3.05;
95% CI, 1.03Y9.02). There were no device refusals.
Conclusions: The combination of cold and vibration decreased venipuncture pain significantly more than standard care without compromising procedural success. A device incorporating these elements could
overcome the common barriers to needle procedure pain control.

bing, or vibration near the site10; or parent coaching and distraction.2,11,12 Although there are data to support each of these
individual treatments, there is no single integrated intervention to optimize pain relief. Furthermore, most current options
require excessive time, cost, or staff training, which are formidable barriers to practice change,2,13 especially in busy medical
settings such as the emergency department (ED).14 An easy-touse, inexpensive, rapidly effective intervention could enhance
procedural pain control in EDs and other fast-paced medical
environments.
The purpose of this study was to compare standard pediatric ED venipuncture pain control practices to a prototype of a
novel battery-powered device, Buzzy (MMJ Labs, Atlanta, Ga),
combining cold, vibration, and distraction. A prior study with
adult volunteers receiving venipuncture provides initial support
for the effectiveness of the combination of cold and vibration,15
but a pediatric device has not been evaluated. We hypothesized
that the device would provide greater pain relief than standard
fast-acting interventions by childrens self-report. Our secondary
aims were to evaluate parent-report and observational measures
of pain for additional evidence of the effectiveness of the device
and to evaluate venipuncture success.

METHODS

Key Words: venipuncture, needle pain, vibration, vapocoolant, pain

Study Design

(Pediatr Emer Care 2011;27: 1151Y1156)

This single-center, prospective randomized clinical trial

was approved by the appropriate institutional review board. The
trial was designed in accord with, and adheres to, the guidelines
detailed in the CONSORT (Consolidated Standards of Reporting
Trials) statement. Informed written consent including the primary investigators conflict of interest was obtained from parents;
written assent was obtained for patients older than 7 years.

enipuncture is a frequent and significant source of childrens medical pain,1,2 reflected in consistent recommendations to provide pain relief whenever possible.3 Current
methods to decrease childrens needle pain include topical
anesthetic creams4Y7; vapocoolant cold spray8,9; pinching, rub-

From the *Pediatric Emergency Medicine Associates; Medical College

of Georgia; Department of Psychology, Georgia State University; and
Childrens Healthcare of Atlanta, Atlanta; ||Department of Mathematics
and Statistics, Kennesaw State University, Kennesaw, GA; and University
of Saskatchewan, Saskatoon, Saskatchewan, Canada.
Disclosure: Dr Baxter invented the device and started MMJ Labs to develop
and manufacture the device. This conflict of interest was disclosed to
participants in the informed consent. After orientation of enrollers
employed by the hospital, Dr Baxter was not present for data collection.
Dr Cohen, who has no financial conflict of interest to disclose,
recruited trained coders for videotape review and performed the data
analysis for the study.
Reprints: Amy L. Baxter, MD, Pediatric Emergency Medicine Associates
LLC, PO Box 422002, Atlanta, GA 30342 (e-mail: Amy_Baxter@
PEMA-LLC.com).
Funding for this study was provided to Georgia State University by the
Mayday Fund, a private foundation dedicated to alleviating the
incidence, degree, and consequence of human physical pain.
Clinical Trials No. NCT00919100.
Copyright * 2011 by Lippincott Williams & Wilkins
ISSN: 0749-5161

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Setting and Participants

The study was conducted at a freestanding urban/suburban
ED with an annual census of 80,000 between April 1 and August
15, 2008. A convenience sample of pediatric patients requiring
venous access was referred by the treating physician during
hours when an ED study enroller was scheduled.
Inclusion criteria were 4- to 18-year-old patients requiring blood tests or venous access. Potential participants were
excluded if they did not speak English and a translator was
unavailable, if there was an abrasion or break in skin where
the device would be placed, if there was previous nerve damage
in the affected extremity, if they were critically ill, or if they
had Raynaud or sickle cell disease involving sensitivity to cold.
Standing orders in the institution allow for triage nurses
to place a topical anesthetic cream of 4% liposomal lidocaine (LMX4; Ferndale Labs, Ferndale, Mich) when a patient is
assessed to have a 50% likelihood of requiring venipuncture. As
the topical anesthetic cream can come off, can be placed by the
triage nurse on an area not chosen for access by the procedure
nurse, or can be placed for an inadequate or excessive amount
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of time, vapocoolant spray (PainEase; Gebauer, Cleveland,

Ohio) is available at the discretion of the cannulating nurse.
Vapocoolant is a compressed gas administered by caregivers
for 4 to 10 seconds at a distance of approximately 12 cm that
numbs by lowering skin temperatures on contact. Vapocoolant
spray has been demonstrated to provide effective venipuncture
pain relief for patients 6 years or older,9 although standard care
at this institution is optional use for all ages.
Because topical anesthetic placement occurred in triage
before the clinical decision for venipuncture was made by a
physician and randomization to standard care, or the device was
stratified for liposomal lidocaine placement. A random-number
table was used in blocks of 10 for patients with and without
anesthetic cream to ensure equal representation across intervention groups. Enrollers unaware of topical anesthetic status
brought cream and no-cream participant packets with group
assignment concealed in opaque envelopes to the room, and
sequential patient number assignment was made on the appropriate packet after informed consent.
Before randomization, the enroller used a standard script
to explain the pain and anxiety measures. After verbal understanding was expressed, the enroller obtained background information and assessed child and parent anxiety. At this point,
subjects opened the envelope to be randomized to the device
or standard care. The device is a reusable 8  5  2.5-cm
handheld plastic bee containing a battery-operated vibrating
motor and a mechanism to attach an ice pack underneath. It can
be pressed in place or secured to a limb via a Velcro strap or
tourniquet (Fig. 1). If randomized to the device, the study
enroller offered the parent and child the opportunity to hold the
device, turn on vibration, and practice application, with total
training time limited to 3 minutes. Immediately before the first
venous access attempt, the nurse or enroller attached the ice pack
under the device, applied the device with a strap at the location
of the tourniquet, and switched on the vibration. Nurses were
then allowed to cannulate as they normally would, provided the
device remained in place and vibrating throughout the attempt.
Removal or turning off the device constituted an adverse event.
For the standard care group, nurses were given no direction other
than to use their normal practice, which might include vapocoolant or distraction at their discretion.

FIGURE 1. Location of device in relation to venipuncture. Arrow

indicates site of venipuncture. Silver ice pack can be seen under
the device; the motor is in the pedestal closest to the venipuncture
site, the switch on the opposite end under antennae. The
device may be attached with tourniquet directly or with Velcro
strap placement above the tourniquet (as was used for this trial).

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The enroller videotaped the venipuncture while attempting to exclude the procedure site, assessed the success of the
venous access attempt (defined as blood retrieval or cannulation achieved on the first needlestick), recorded the time required for the first venous access attempt, noted whether
vapocoolant was used, and documented any distraction attempts
in both groups (eg, adult telling stories or singing or the child
watching television).

Measures
Demographics (ie, race and mothers age and highest
grade completed) were collected via a self-report form. Triage
acuity, age, weight, and chief complaint were obtained from
information recorded at ED triage.
Preprocedural anxiety was assessed using the anxiety scale
from the Childrens Anxiety and Pain Scale (CAPS).16 The
CAPS contains 2 sets of 5 drawings of childrens faces exhibiting increasing levels of anxiety and pain. The 1- to 5-point scale
has been used in pediatric pain research and practice and has
good psychometrics.17
The primary outcome was the childs self-report of pain
with the first venipuncture attempt using the Faces Pain ScaleY
Revised (FPS-R).18 The FPS-R is a 0- to 10-point scale consisting of 6 cartoon faces that range from a neutral expression
(0, no pain) to a screaming face (10, severe pain). The
FPS-R has been validated down to age 4 years, is cited in
more than 140 studies, and is deemed by reviewers as a wellestablished measure.19 Parents blinded to the childs response
also rated their childs pain using the FPS-R after the first venipuncture attempt.
A secondary outcome was a count of distress behaviors
observed on videotapes using codes from the Observational
Scale of Behavioral Distress (OSBD).20 The OSBD is a validated
and commonly used scale and has been described as a wellestablished measure of pediatric pain.17 Typically, the 11
OSBD distress responses (information seeking, cry, scream,
physical restraint, verbal resistance, seeking emotional support,
verbal pain, flail, verbal fear, muscular rigidity, and nervous
behavior) are coded in 15-second intervals before, during,
and after longer procedures to control for baseline anxiety and
habituation. Other studies evaluating brief procedures such as
needle pain distress have assigned a composite 1- to 11-point
score.21 As baseline anxiety in our study was assessed using
the CAPS and only the first attempt was evaluated, a composite OSBD score of 1 to 11 was assigned from the time of
placement of tourniquet to placement of the bandage or securing the intravenous line (IV) after the first attempt. Two students
not associated with the hospital or the device had been previously trained in this methodology and coded all tapes. A
supervisor assessed interrater reliability on each coded behavior. After each group of 10 subjects, interrater agreements that
fell below the level of excellent agreement (J = 0.80) were reviewed and discussed by both coders, with the consensus score
recorded and definitions of observed behaviors refined. Both
coders were blinded to study aims and hypotheses; the coders
and the supervisor were not involved in other aspects of the study
and had no conflict of interest. As coders could hear the sound
of the device on the tapes, blinding attempts by obscuring the
procedure site were not effective, and the observational ratings
should not be considered blinded.

Data Analysis
A previous immunization pain study in children aged 4 to
6 years found FPS-R ratings of 4.21 (SD, 1.14) versus 3.08 (SD,
1.35) when using cold spray and distraction versus EMLA21;
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Volume 27, Number 12, December 2011

thus, we calculated that 33 patients in each group would detect

a difference with a power of 0.95 and > of 0.05 (G*Power 3.11;
Faul, Universitat Kiel, Kiel, Germany).22 Anticipating possible
videotape problems and given our wider age range, we planned
to enroll 40 patients in each group. Group assignment was analyzed by intention-to-treat.
Categorical values are presented as the percentage of frequency with W2 comparisons or Fisher exact test when appropriate. Tests of normality indicated that both pain and anxiety
were nonYnormally distributed; thus, group comparisons were
conducted using the Mann-Whitney-Wilcoxon test for these
results. Student t tests were used to compare normally distributed
means for the demographic information.

RESULTS
Preliminary Analyses
Ninety-four patients were evaluated, one was ineligible
because of sickle cell disease status, and 12 declined participation (Fig. 2). The final sample consisted of 81 patients aged 4 to
18 years (mean, 9.97 [SD, 3.83] years) receiving venous access.
Additional demographic data are presented in Table 1.
Treatment groups did not differ by sex, age, child or parent
preprocedure anxiety, IV time for successful attempts or overall mean time, type of procedure, or number of patients who

Vibration and Cold Relieve Venipuncture Pain

received lidocaine cream (Table 1). Blood draws were slightly

more common in the Buzzy group (6/41 vs 2/40, P = 0.26);
however, there were no differences in pain or distress between
cannulation and blood draw on self-report (median difference, 1;
P = 0.286), parent proxy report (median difference, 0; P =
0.608), or OSBD (median difference, 0; P = 0.774).
There were no adverse events (refusals of the study device)
after enrollment. LMX was used for 20 (50%) of 40 standard
care patients and 19 (46%) of 41 Buzzy patients. Nine of the
22 patients in the device group who did not have anesthetic
cream also received vapocoolant. Of the 20 patients in the
standard care group without lidocaine, all received vapocoolant
except for 2 who refused the cold spray.

Primary Analyses
Consistent with hypotheses, children in the device group
had significantly lower pain or distress based on self-report
(Table 2). As younger children often report greater pain with
procedures,23 separate regression models were used to test the
interaction of intervention and age on self-reported pain. Age
and treatment group were entered in the first step of the regression model. At the second level, the age  condition interaction term was entered. Age and condition accounted for 14%
of the variance in childrens venipuncture pain (P = 0.004).
Age was a significant predictor of self-reported pain, A = j0.26,

FIGURE 2. CONSORT diagram showing the flow of participants.

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TABLE 1. Continuous and Categorical Demographic and

Cannulation-Related Variables by Treatment Group
Treatment Group
Standard Care
(n = 40)

Device
(n = 41)

Child age, median (95% CI) 9.91 (6.68Y11.08) 10.10 (8.91Y11.99)

Child sex, % male
45
58.5
Race, %
White
67.5
58.5
Black
12.5
12.2
Asian
0
2.4
Hispanic or Latino
10
22
Other
10
4.9
Mothers age, mean (SD) 39.6 (4.85)
39.15 (6.38)
Mothers highest
4.62 (1.18)
4.28 (1.38)
education, mean (SD)
Child preprocedure
3 (2Y4)
2 (2Y3)
anxiety, median (95% CI)
Parent preprocedure
3 (3Y4)
3 (2Y4)
anxiety, median (95% CI)
LMX4, % used
50
46.3
Site of venous access, %
Hand
60
63.4
Antecubital fossa
35
31.7
Forearm
5
2.4
Other
0
2.4
Type of venous access,
(n/n) %
Cannulation
(38/40) 95
(35/41) 85.4
Blood draw
(2/40) 5
(6/41) 14.6
CI indicates confidence interval.

P = 0.018, with younger children reporting more pain. Treatment condition predicted self-reported pain, A = 0.23, P = 0.034,
but age  condition interaction did not account for a significant amount of unique variance in pain (G1%), suggesting that
age does not moderate the effects of Buzzy on pain. The effects
of age and condition are illustrated in Figure 3.

FIGURE 3. Mean self-report of pain intensity as a function

of condition (standard care control vs Buzzy) and age (4Y9 vs
10Y17 years), showing 95% confidence intervals and cell n.
One control patient (aged 6 years; caregiver pain rating, 8)
did not record a pain rating.

Secondary Analyses
Children in the device group had significantly lower pain
by parent report and the observational scale than children in
the standard care group (Table 2). The odds of success with
blood retrieval or cannulation on the first attempt were 3 times
more likely in the device group than in the standard care group
(Table 2).
In the standard care group, 21 of 40 patients had attempted
distraction by parents, watching TV, and/or by a health care
worker; 2 wanted to watch the IV being placed. In the device
group, 29 of 41 patients had attempted distraction. There was
no difference in self-reported pain for the device group or the
overall sample between those who had distraction offered and
those who did not.

DISCUSSION
The purpose of this study was to evaluate a multifaceted
intervention incorporating cold, vibration, and distraction for
childrens procedural pain. Results suggested that the vibration

TABLE 2. Median Pain and Distress Differences and 95% Confidence Intervals of Dependent Variables by Treatment Group
Treatment Group
More than 1 venous access attempt, %
Minutes to IV access, mean (SD)
In successful attempts
Overall time

Standard Care (n = 40)

Device (n = 41)

Odds Ratio (95% CI)

35

15

3.05 (1.03Y9.02)

0.040

3.57 (2.45)
7.33 (11.42)

3.12 (2.17)
5.43 (6.93)

0.44
0.37
Difference of Medians (95% CI)

Self-reported pain (FPS-R)

Parent-reported child pain (FPS-R)
OSBD

4 (2Y6)*
4 (2Y6)
2 (1Y3)

2 (2Y2)
2 (0Y4)
1 (0Y2)

j2 (j4 to 0)
j2 (j4 to j2)
j1 (j2 to 0)

0.029
0.005
0.036

Faces Pain ScaleYRevised was scored from 0 to 10; the OSBD for our study was scored from 1 to 11.
*Missing 1: parent reported 8; enroller documented child was too lethargic and would not circle or indicate face.

Missing 2: one parent stepped out of room for procedure; one was asleep.

Missing 2: one parent stepped out of room for procedure; one was on cell phone.
CI indicates confidence interval.

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Volume 27, Number 12, December 2011

and cold aspects of the device effectively decreased pain compared with standard care and did not impact IV success.
Potential negative repercussions of untreated pediatric
needle pain include heightened distress at subsequent procedures,2 avoidance of medical care,24,25 missed vaccinations,6,26,27 and not engaging in blood donation as an adult.28Y30
Needle pain relief might address the issues of needle anxiety,
facilitate the medical procedure,31 and heighten patient satisfaction.32 It is critical, however, that pain relief treatment be
not only effective, but also sufficiently practical to be used in
busy medical settings.2
The best studied interventions for venipuncture pain are
topical anesthetics.33,34 Although relief from creams such as
EMLA, LMX-4, and Ametop is well established,35 the extra step
of applying the cream and the 30 to 60 minutes required for
efficacy may slow ED flow. In addition, if the cream comes off
or is inappropriately placed, the US $4 to $8 hospital cost per
application is wasted.
Cold and vibration are quick-acting options for pain relief.
The Gate Control Theory36 suggests that pain is transmitted
from the peripheral nervous system to the central nervous system where it is modulated by a gating system in the dorsal horn
of the spinal cord. More specifically, the afferent pain-receptive
nerves (A-delta fibers carrying acute pain and unmyelinated
slower C fibers carrying chronic pain messages) are blocked
by fast nonnoxious motion nerves (A-beta).37 Prolonged cold
stimulates the C fibers and, if preceding the pain, may further
block the A-delta pain signal. Another mechanism by which the
cold sensation is effective is by triggering descending (or diffuse)
noxious inhibitory controls, activating a supraspinal modulation
raising the bodys overall pain threshold.38 Although cold spray
likely functions via these mechanisms, the brevity of the cold
sensation may not maximize C fiber summation blockade effects.
The 15- to 30-second duration of contact for the device during
cleaning and preparation for venipuncture may enhance C fiber
summation and descending (or diffuse) noxious inhibitory control
pain relief.
The only widely used product that addresses venipuncture
pain relief in seconds is vapocoolant spray. Vapocoolant spray
is inexpensive at approximately US $0.50 per use, with greater
efficacy in older populations more similar to the age distribution in our study. Farion et al9 found a 19-mm/100-mm reduction in pain on a colored visual analog scale for subjects with a
mean age of 9.4 years, whereas Davies and Molloy39 reported
similar pain relief using ethyl chloride or topical anesthetics
for venipuncture in children 5 to 13 years old. In contrast,
however, Costello et al40 found no improvement in pain between
ethyl chloride spray, placebo, and nothing for children between
9 and 18 years. Ramsook et al8 found no difference in younger
children and equivalent efficacy to placebo for children aged
6 to 12 years, with a nonsignificant improvement in children
older than 12 years. Despite the modest pain relief, the combination of speed and low cost make this a popular option in ED
pain relief.
The device costs US $39.95 and comes with replaceable
batteries and a reusable ice pack. One unit will vibrate strongly for
at least 20 hours, yielding approximately 380 needle attempts
per unit, or $0.09 per attempt. Subsequent costs depend on the
variable price of batteries, and whether reusable or disposable ice
wings (US $0.30) are used. The added step of obtaining a frozen
pack may be a barrier to use; this study did not assess the effectiveness of the device by the nursing staff, or its ease of use.
There were 3 significant limitations in the current investigation. First, as the device could be seen and heard on the
videotapes and by the patients, subjects and coders could not be
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Vibration and Cold Relieve Venipuncture Pain

blinded to intervention groups. Although coders were not

privy to hypotheses, they might have developed biases that influenced coding. Likewise, placebo effects of the device were
not controlled using a sham device and may have contributed to
the results for both patient and parent self-report. Second, despite randomization, the groups may have had small differences
in type of procedure (blood draw or IV start), sex, and initial
anxiety, which cumulatively could have biased results in favor
of the device. As randomization occurred after subject enrollment and rating of preprocedural anxiety, systematic selection
bias should have been prevented, but with small sample sizes,
minor random differences can be important. A third limitation
was the lack of consistency in intervention. The primary investigators were not present for data collection and instructed the
enrollers only to record while nurses cannulated as they normally do. For this reason, although the intent of the design
assumed nurses would use Buzzy only in the study condition,
it was not clear until data collection was complete that some
nurses also introduced vapocoolant in the device arm. Although
vapocoolant was used in 9 of 41 device patients, this should have
biased results toward the null hypothesis.
In summary, a vibrating cold device containing many of
the optimal components to overcome barriers to pain treatment6
proved to be an effective pediatric pain management intervention. The technology of vibration and cold is inexpensive
and reusable, requires little extra time, can be implemented by
the patient rather than medical staff, and may be beneficial for
patients across a range of ages. Venous access is a shallow procedure, and additional research is necessary to determine whether
the device might be provide pain relief for intramuscular injection, fingersticks, port access, or other more invasive procedures. Additional studies are warranted to replicate these findings,
evaluate the extent of its efficacy, and explore use with other
painful procedures, but these findings are promising for this new
pediatric pain management tool.
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