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

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.

Study Overview

• Status: Unknown
• Conditions: Analgesia; Topical Anesthetic
• Intervention / Treatment: Drug: Ametop; Device: Pain Ease Cold Spray

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 Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4V4
      • BC Children's Hospital - Department of Anesthesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 16 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Comparator: Ametop only; Ametop Gel applied as sole topical anesthetic.	Drug: Ametop; Tetracaine Hydrochloride Gel 4%; Other Names: Ametop Gel
EXPERIMENTAL: Intervention: Pain Ease Cold Spray; Pain Ease Cold spray applied immediately before IV insertion, as an adjunct to Ametop Gel.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insertion attempts	Total number of insertion attempts required for successful placement of IV cannula	intraoperative
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

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Stephan Malherbe, FRCA, BC Children's Hospital, Department of Anesthesia

Publications and helpful links

Helpful Links

• Pediatric Anesthesia Research Team website

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 20, 2018
• Primary Completion (ANTICIPATED): December 31, 2019
• Study Completion (ANTICIPATED): December 31, 2019

Study Registration Dates

• First Submitted: November 16, 2018
• First Submitted That Met QC Criteria: November 19, 2018
• First Posted (ACTUAL): November 21, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 21, 2018
• Last Update Submitted That Met QC Criteria: November 19, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Pain Ease; Ametop Gel
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Tetracaine
• Other Study ID Numbers: H18-02364

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes