NCT03749915

Ametop Compared to Ametop With Pain Ease Spray

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 5 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Analgesia
• Topical Anesthetic

Interventions

Type	Name	Description
DEVICE	Pain Ease Cold Spray	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.
DRUG	Ametop	Tetracaine Hydrochloride Gel 4%

Timeline

• Start date: 2018-11-20
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2018-11-21
• Last updated: 2018-11-21

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study