Ametop Compared to Ametop With Pain Ease Spray | NCT03749915

Studies
Ametop Compared to Ametop With Pain Ease Spray

NCT03749915

Sponsor

University of British Columbia

Status

Unknown status

Last Update Posted

Nov 21, 2018Actual

Enrollment

240Estimated

Phase

Not Applicable

Conditions

Analgesia
Topical Anesthetic

Interventions

Pain Ease Cold Spray
Ametop

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 20, 2018Estimated

Primary Completion Date

Dec 31, 2019Estimated

Completion Date

Dec 31, 2019Estimated

First Submitted Date

Nov 16, 2018

First Submission Date that Met QC Criteria

Nov 19, 2018

First Posted Date

Nov 21, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 19, 2018

Last Update Posted Date

Nov 21, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Stephan Malherbe, Associate Professor, University of British ColumbiaPrincipal Investigator

Lead Sponsor

University of British ColumbiaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

240Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Comparator: Ametop only	Active Comparator	Ametop Gel applied as sole topical anesthetic.	Drug: Ametop
Intervention: Pain Ease Cold Spray	Experimental	Pain Ease Cold spray applied immediately before IV insertion, as an adjunct to Ametop Gel.	Device: Pain Ease Cold Spray

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pain Ease Cold Spray	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	intraoperative

Secondary Outcomes

Measure	Description	Time Frame
Insertion attempts	Total number of insertion attempts required for successful placement of IV cannula	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.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andrew Poznikoff, BSc	Contact	604-875-2000	1989	andrew.poznikoff@cw.bc.ca
Stephan Malherbe, FRCA	Contact	604-875-2711		smalherbe@cw.bc.ca

Overall Officials

Name	Affiliation	Role
Stephan Malherbe, FRCA	BC Children's Hospital, Department of Anesthesia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
BC Children's Hospital - Department of Anesthesia		Vancouver	British Columbia	V5Z 4V4	Canada

References Module

Citations

Not provided

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

ID	Term
D062366	para-Aminobenzoates
D062365	Aminobenzoates
D001565	Benzoates
D000146	Acids, Carbocyclic