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
Overview
- Phase
- Not Applicable
- Intervention
- Ametop
- Conditions
- Analgesia
- Sponsor
- University of British Columbia
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Pain-free IV insertion
- Last Updated
- 7 years ago
Overview
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.
Investigators
Stephan Malherbe
Associate Professor
University of British Columbia
Eligibility Criteria
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
Arms & Interventions
Comparator: Ametop only
Ametop Gel applied as sole topical anesthetic.
Intervention: Ametop
Intervention: Pain Ease Cold Spray
Pain Ease Cold spray applied immediately before IV insertion, as an adjunct to Ametop Gel.
Intervention: Pain Ease Cold Spray
Outcomes
Primary Outcomes
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 Outcomes
- Insertion attempts(intraoperative)
- FPS-R pain score(intraoperative)