Ametop Compared to Ametop With Pain Ease Spray

University of British Columbia

Status: Unknown

Conditions: Analgesia; Topical Anesthetic

Treatments: Device: Pain Ease Cold Spray; Drug: Ametop

Study type: Interventional

Funder types: Other

Identifiers

NCT03749915

H18-02364

Details and patient eligibility

About

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 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 5 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 2 patient groups

Comparator: Ametop only

Active Comparator group

Description:

Ametop Gel applied as sole topical anesthetic.

Treatment:

Drug: Ametop

Intervention: Pain Ease Cold Spray

Experimental group

Description:

Pain Ease Cold spray applied immediately before IV insertion, as an adjunct to Ametop Gel.

Treatment:

Device: Pain Ease Cold Spray