Effectiveness of External Vibration for Pain Relief During Intravenous Access in Adult Patients
Condition: Pain Management; Anxiety
Study type: Interventional

Summary: 
      A large number of dentoalveolar (tooth extraction) procedures performed by Oral and
      Maxillofacial Surgeons utilize intravenous sedation. Procedures commonly performed may
      include surgical removal of teeth, bone grafting, surgical placement of dental implants, and
      removal of cysts or tumors from the jaws, among others. Obtaining peripheral intravevenous
      (IV) cannulation often proves to be a very stressful and anxious event for the patient. The
      anxiety and stress from the venipuncture alone affects not only the psychological stability
      of the patient, but also the patient's physiology. The Buzzy vibration external stimulation
      device has shown to be an effective tool in pediatric venipunture procedures. The aim of this
      study is to investigate the effects of the Buzzy stimulation device in pain and anxiety
      reduction during peripheral intravenous cannulation in an adult population.

      Enrollees in this study will be patients who will undergo dental surgery with intravenous
      sedation. The patients who are enrolled will receive an IV either with or without the Buzzy.
      The Buzzy is a small vibration device which will be placed next to the IV placement site.
    

Detailed description: 
      The participants will be randomized into two groups, those who use the Buzzy system
      (experimental), and routine IV start (control). Prior to knowing their group, all patients
      will answer the "Before Intravenous Catheterization" portion of the form in order to
      eliminate bias. After this portion is complete, their group (experimental vs control) will be
      determined from opening a blinded envelope.

      A tourniquet will be placed, followed by the Buzzy stimulation device (if in the experimental
      group). An alcohol swab will be used and then a 22 gauge IV catheter will be inserted,
      connected to fluids, and secured with tape. The antecubital fossa or the dorsal hand/wrist
      will be the only sites used in the study. All participants will fill out the post-insertion
      questions on the form and those patients that used the Buzzy system will then fill out the
      several specific questions related to the experimental group. This will conclude the
      patient's involvement in the study. The patient will then continue with treatment as planned.
      We will plan to exclude cases where the IV is not obtained on the first attempt, if a smaller
      or larger gauge IV catheter is required, or if an insertion site not listed above is
      required. The case will be excluded if adjunctive steps are taken to obtain IV access (i.e.
      Oral sedation, nitrous oxide, heat packs).
    

Intervention name(s): Buzzy; Placebo
Intervention type(s): Device; Other
Intervention description(s): The Buzzy is a reusable device that applies vibration to the skin surface to override the body's gate control pain pathway. It has been used effectively to reduce the discomfort of intravenous cannulation (IV placement) in pediatric patients. Also, it has been utilized to reduce the discomfort of injections in pediatric and adult patients. We are preforming this study to evaluate the effectiveness of the Buzzy in reducing the discomfort associated with intravenous cannluation (IV placement) in adults.; No use of the Buzzy (standard IV access techniques)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pain; Anxiety; intravenous access