Ametop Compared to Ametop With Pain Ease Spray
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|ClinicalTrials.gov Identifier: NCT03749915|
Recruitment Status : Not yet recruiting
First Posted : November 21, 2018
Last Update Posted : November 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Analgesia Topical Anesthetic||Device: Pain Ease Cold Spray Drug: Ametop||Not Applicable|
The aim of this study is to assess the effectiveness of Pain Ease® spray, used as an adjunct to Ametop Gel™.
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.
- To determine if using Pain Ease® spray as an adjunct to Ametop Gel™ will increase the number of pain free venipunctures Secondary Objectives
- To document the side effects of Pain Ease® spray and Ametop Gel™
- To document the number of attempts for a successful IV insertion
The investigators propose a patient-blinded randomized control trial of Ametop Gel™ with and without Pain Ease® spray as an adjunct.
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 (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Estimated Study Start Date :||November 20, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Active Comparator: Comparator: Ametop only
Ametop Gel applied as sole topical anesthetic.
Tetracaine Hydrochloride Gel 4%
Other Name: 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.
- 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.
- Insertion attempts [ Time Frame: intraoperative ]Total number of insertion attempts required for successful placement of IV cannula
- FPS-R pain score [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03749915
|Contact: Andrew Poznikoff, BSc||604-875-2000 ext firstname.lastname@example.org|
|Contact: Stephan Malherbe, FRCAemail@example.com|
|Canada, British Columbia|
|BC Children's Hospital - Department of Anesthesia|
|Vancouver, British Columbia, Canada, V5Z 4V4|
|Contact: Andrew Poznikoff, BSc 604-875-2000 ext 1989 firstname.lastname@example.org|
|Contact: Stephan Malherbe, MBBS, FRCA 604-875-2711 email@example.com|
|Principal Investigator: Stephan Malherbe, FRCA|
|Sub-Investigator: Louis Scheepers, FRCA|
|Sub-Investigator: Zoe Brown, FRCA|
|Sub-Investigator: Andrew Poznikoff, BSc|
|Sub-Investigator: Robert Purdy, FRCA|
|Sub-Investigator: Eleanor Reimer, FRCA|
|Sub-Investigator: Rachelle Scheepers|
|Principal Investigator:||Stephan Malherbe, FRCA||BC Children's Hospital, Department of Anesthesia|