Analgesia Clinical Trial
Official title:
A Single Blinded Observational Study of the Effectiveness of a Pain Ease Local Anesthetic Spray, Combined With Ametop Gel, to Reduce the Discomfort of Intravenous Insertion
The investigators propose to examine if Pain Ease spray, used as an adjunct to the topical anesthetic Ametop Gel, can improve the percentage of pain-free IV starts.
Purpose:
The aim of this study is to assess the effectiveness of Pain Ease® spray, used as an adjunct
to Ametop Gel™.
Hypothesis:
The investigators hypothesize that using Pain Ease® spray as an adjunct to the standard use
of Ametop Gel™ will increase the number of pain free venipunctures from 30% to 50% or more.
Objectives:
Primary Objective
1. To determine if using Pain Ease® spray as an adjunct to Ametop Gel™ will increase the
number of pain free venipunctures Secondary Objectives
2. To document the side effects of Pain Ease® spray and Ametop Gel™
3. To document the number of attempts for a successful IV insertion
Research Design:
The investigators propose a patient-blinded randomized control trial of Ametop Gel™ with and
without Pain Ease® spray as an adjunct.
Statistical Analysis:
An interim analysis will be performed at the study's halfway point after recruitment of 120
participants. A score on the Faces Pain Scale - Revised (FPS-R) of either 0 or 2 will be
considered a pain-free IV start, while a score of 4-10 will be considered a painful IV
cannula insertion. Fischer's Exact test will be used to determine statistical significance; a
critical alpha of 0.05 will be considered for significance.
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