Ametop Compared to Ametop With Pain Ease Spray

Not Applicable

• Conditions: Analgesia; Topical Anesthetic
• Interventions: Device: Pain Ease Cold Spray; Drug: Ametop

• Registration Number: NCT03749915
• Lead Sponsor: University of British Columbia

Brief 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.

Study Timeline

• Status Verified: 2018-11
• Study First Submitted: 2018-11-16
• Study First Submitted QC: 2018-11-19
• Last Update Submitted: 2018-11-19
• Study Start: 2018-11-20
• Study First Posted: 2018-11-21
• Last Update Posted: 2018-11-21
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

BC Children's Hospital - Department of Anesthesia; 🇨🇦 Vancouver, British Columbia, Canada