Ametop Compared to Ametop With Pain Ease Spray

Study Overview
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Brief Summary
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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.

Detailed Description
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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 To determine if using Pain Ease® spray as an adjunct to Ametop Gel™ will increase the number of pain free venipunctures Secondary Objectives To document the side effects of Pain Ease® spray and Ametop Gel™ 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.

Official Title
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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

Conditions
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Analgesia, Topical Anesthetic

Intervention / Treatment
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* Device: Pain Ease Cold Spray
* Drug: Ametop


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I & II Elective day case procedure requiring an IV Exclusion Criteria: Planned IV insertion after inhalation induction Developmental delay or inability to interpret the Revised Faces Pain Scale (FPS-R)10 Ametop Gel™ application < 30 minutes before estimated IV start at time of screening Allergies to any of the components in Ametop Gel™, Pain Ease® spray, or adhesives Patients receiving sedative pre-medication Severe Needle phobia

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Comparator: Ametop only<br>Ametop Gel applied as sole topical anesthetic. | Drug: Ametop<br>* Tetracaine Hydrochloride Gel 4%<br>* Other names: Ametop Gel;|
| Experimental: Intervention: Pain Ease Cold Spray<br>Pain Ease Cold spray applied immediately before IV insertion, as an adjunct to Ametop Gel. | Device: Pain Ease Cold Spray<br>* Pain Ease is a spray containing 1,1,1,3,3-Pentafluoropropane (HFC-245fa) and 1,1,1,2-Tetrafluoroethane (HFC-134a). It is a vapocoolant for use as a topical anesthetic.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain-free IV insertion | The number of pain free IV insertions as measured by participant indicating 0 or 2 on the Faces Pain Scale - Revised. | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insertion attempts | Total number of insertion attempts required for successful placement of IV cannula | intraoperative | 
| FPS-R pain score | Mean Faces Pain Scale - Revised pain score by group. 0-10 pain score of 0 being no pain and 10 being most pain ever experienced. | intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain Ease, Ametop Gel