Ametop Compared to Ametop With Pain Ease Spray

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 31, 2019

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.

Interventions

  • 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%

Arms, Groups and Cohorts

  • Active Comparator: Comparator: Ametop only
    • Ametop Gel applied as sole topical anesthetic.
  • Experimental: Intervention: Pain Ease Cold Spray
    • Pain Ease Cold spray applied immediately before IV insertion, as an adjunct to Ametop Gel.

Clinical Trial Outcome Measures

Primary Measures

  • Pain-free IV insertion
    • Time Frame: intraoperative
    • The number of pain free IV insertions as measured by participant indicating 0 or 2 on the Faces Pain Scale – Revised.

Secondary Measures

  • Insertion attempts
    • Time Frame: intraoperative
    • Total number of insertion attempts required for successful placement of IV cannula
  • FPS-R pain score
    • Time Frame: intraoperative
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 5 Years

Maximum Age: 16 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of British Columbia
  • Provider of Information About this Clinical Study
    • Principal Investigator: Stephan Malherbe, Associate Professor – University of British Columbia
  • Overall Official(s)
    • Stephan Malherbe, FRCA, Principal Investigator, BC Children’s Hospital, Department of Anesthesia
  • Overall Contact(s)
    • Andrew Poznikoff, BSc, 604-875-2000, andrew.poznikoff@cw.bc.ca

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