Analgesia, Topical Anesthetic
Conditions
Keywords
Pain Ease, Ametop Gel
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.
Interventions
DEVICEPain 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.
DRUGAmetop
Tetracaine Hydrochloride Gel 4%
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
5 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada
Contacts
Primary ContactAndrew Poznikoff, BSc
Backup ContactStephan Malherbe, FRCA
Outcome results
None listed