Ametop Compared to Ametop With Pain Ease Spray

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03749915
• Other study ID #: H18-02364
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 20, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: November 2018
• Source: University of British Columbia
• Contact: Andrew Poznikoff, BSc
• Phone: 604-875-2000
• Email: andrew.poznikoff[@]cw.bc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Topical Anesthetic

Intervention

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%

Locations

Country	Name	City	State
Canada	BC Children's Hospital - Department of Anesthesia	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Insertion attempts	Total number of insertion attempts required for successful placement of IV cannula	intraoperative
Secondary	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

External Links

•   Pediatric Anesthesia Research Team website