Vibrating, Cold Device for Pediatric Intravenous (IV) Cannulation Pain Relief

Intravenous (IV) cannulation is a significant source of pediatric pain and distress.
Accumulating evidence has demonstrated that pain from IV cannulation is a significant source
of pediatric pain and distress with effects far more reaching than the presenting event.
When describing worse pain experiences in hospitalized children, IV cannulation pain was
found to be second only to pain related to the subject's underlying disease. Practitioners
recognize the need to mitigate or decrease pediatric IV cannulation pain and distress in
emergency department patients, yet often do not provide the relief measures that are
available. The use of topical lidocaine cream has some barriers, including the need to
predict the need for the IV, the 30 minute administration time, difficulty in applying and
maintaining the cream, the need for a physician's order and nursing to override in the Pyxis
machine in order to obtain the medication in a timely manner.

Buzzy® provides a potential alternative to treating pediatric IV cannulation pain in the
emergency department (ED), as cold and vibration are quick-acting options for pain relief.
If Buzzy® is demonstrated to be as effective or more effective for reducing the pain of IV
cannulation it would be an inexpensive and rapid way to provide pain control in accordance
to the American Academy of Pediatrics (AAP) and American Pain Society recommendations. The
device's actions are based on the Gate Control Theory, whereby cold and vibratory
stimulation stimulate large fiber and inhibitory neurons to interrupt nociception. The
benefits of Buzzy® include a low cost of $34.99 per reusable device, which could also
provide a significant cost savings over the use of single tubes of topical lidocaine cream
at a cost of $4.62-12.00 per tube with one or more tubes needed for each patient. Buzzy®
does not require a medical order, but must be cleaned according to institution standards and
is supplied with either a reusable cold pack or single use cold packs as desired. The
commonly voiced concern related to the application of cold causing vasoconstriction has not
been borne out in prior studies of Buzzy®.

Self-report of pain is the gold standard in evaluating pediatric pain. For this study we
will use the Faces Pain Scale-Revised (FPS-R) for rating self-reported pain in children ages
4-18 years. The FPS-R has been validated and frequently used in pediatric pain studies. The
FPS-R consists of 6 cartoon faces that range from a neutral expression ("no pain") to one of
very much pain. Using the same faces, children will be asked how much the procedure "hurt"
from "no hurt" to "very much hurt". Self-reporting of pain is the primary source of data and
a secondary measure of data will be an observational pain scale, the face, legs, activity,
cry, consolability (FLACC) scale. Because anxiety has proven to affect pain ratings, we
will also evaluate anxiety using "Child Rating of Anxiety Scale", a visual semantic scale in
the form of a thermometer for rating anxiety.

All subjects in this study will develop and implement a coping plan with a Child Life
Specialist, including preparation, distraction, and deep breathing. This is standard of care
in our ED and applied whenever possible for IV placement procedures. Child Life Specialists
prepare subjects and families prior to medical procedures to decrease anxiety and increase
understanding. Psychological preparation is aimed to increase a subject and family's control
over a situation or procedure. While decreasing anxiety and increasing control, the child
can move past the event with a sense of mastery and a low level of distress. Preparation
close to the event is important for younger subjects, whereas preparation for older subjects
is more beneficial when initiated earlier. The effectiveness of distraction in needle
related procedures is well documented in the literature. Distraction involves a supportive
care giver (if present) as well as a Certified Child Life Specialist; all attempts are made
to focus of child away from the pain of the procedure and when possible the child is
permitted to hold the objects and manipulate them prior to the procedure to enhance the
utilization of a coping plan.

Inclusion Criteria:

- Subject is aged 4 to 18 years of age

- Subjects will be having a peripheral IV line placed at the discretion of the
treating physician for usual care of presenting complaints.

- Physician in charge of the subject is willing to wait the 30 minutes needed for the
study preparation

- Subject/caregiver understands English

- Parent or legal guardian has signed Institutional Review Board (IRB) approved
informed consent and subject (if age 7 years or older) has given assent

Exclusion Criteria:

- Subject is critically ill with a triage category of 1

- Subject has a condition that precludes the use of the self-report pain scale

- Subject has an abrasion, infection or break in skin in the area where Buzzy® would be
placed

- Nerve damage is present in the extremity for planned IV placement