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N/A N=100 Randomized Treatment

Effectiveness of External Vibration for Pain Relief During Intravenous Access in Adult Patients

Pain Management · Anxiety

Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Change in Pain — 1.55; 1.76 score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Buzzy (Device); Placebo (Other)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Kyle Stein
Primary completion
Aug 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Pain
1.55; 1.76
PRIMARY
Change in Anxiety
1.70; 1.84

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.

Eligibility Criteria

Inclusion Criteria

  • Ages 18 and 40.
  • Eligible for third molar removal with sedation.

Exclusion Criteria

  • Not eligible for surgery.
  • Not eligible for sedation.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03619135). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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