Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
240 participants
INTERVENTIONAL
2018-11-20
2019-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Comparator: Ametop only
Ametop Gel applied as sole topical anesthetic.
Ametop
Tetracaine Hydrochloride Gel 4%
Intervention: Pain Ease Cold Spray
Pain Ease Cold spray applied immediately before IV insertion, as an adjunct to Ametop Gel.
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.
Interventions
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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.
Ametop
Tetracaine Hydrochloride Gel 4%
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Elective day case procedure requiring an IV
Exclusion Criteria
* 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
5 Years
16 Years
ALL
No
Sponsors
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University of British Columbia
OTHER
Responsible Party
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Stephan Malherbe
Associate Professor
Principal Investigators
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Stephan Malherbe, FRCA
Role: PRINCIPAL_INVESTIGATOR
BC Children's Hospital, Department of Anesthesia
Locations
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BC Children's Hospital - Department of Anesthesia
Vancouver, British Columbia, Canada
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Pediatric Anesthesia Research Team website
Other Identifiers
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H18-02364
Identifier Type: -
Identifier Source: org_study_id
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