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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
240
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.
Tetracaine Hydrochloride Gel 4%
BC Children's Hospital - Department of Anesthesia
Vancouver, British Columbia, Canada
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.
Time frame: intraoperative
Insertion attempts
Total number of insertion attempts required for successful placement of IV cannula
Time frame: 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.
Time frame: intraoperative
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