Vibrating, Cold Device for Pediatric Intravenous (IV) Cannulation Pain Relief
Condition: Pain; Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test the effectiveness of Buzzy®, a battery-powered reusable
      device that provides cold and vibration, in reducing the pain associated with intravenous
      (IV) cannulation. The investigators will investigate if Buzzy® is as effective as topical
      lidocaine cream in reducing the pain associated with IV cannulation.
    

Detailed description: 
      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.
    

Intervention name(s): Buzzy; Topical Lidocaine 4% Cream
Intervention type(s): Device; Drug
Intervention description(s): Cold, Vibrational Device; Applied to anticipated IV site at least 30 minutes prior to cannulation.
Other intervention name(s): AneCream™; Anestacon®; Dalcaine®; L-M-X™4; Xylocaine®
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pain; Anxiety; IV Cannulation; Topical Lidocaine; Buzzy; Face, Legs, Activity, Crying, Consolability (FLACC) scale; Faces Pain Scale Revised (FPS-R); Child Rating of Anxiety Scale