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Ametop Compared to Ametop With Pain Ease Spray

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03749915
Recruitment Status : Not yet recruiting
First Posted : November 21, 2018
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
Stephan Malherbe, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Analgesia Topical Anesthetic Device: Pain Ease Cold Spray Drug: Ametop Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Comparator: Ametop only
Ametop Gel applied as sole topical anesthetic.
Drug: Ametop
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Insertion attempts [ Time Frame: intraoperative ]
    Total number of insertion attempts required for successful placement of IV cannula

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03749915


Contacts
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Contact: Andrew Poznikoff, BSc 604-875-2000 ext 1989 andrew.poznikoff@cw.bc.ca
Contact: Stephan Malherbe, FRCA 604-875-2711 smalherbe@cw.bc.ca

Locations
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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    andrew.poznikoff@cw.bc.ca   
Contact: Stephan Malherbe, MBBS, FRCA    604-875-2711    smalherbe@cw.bc.ca   
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         
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Stephan Malherbe, FRCA BC Children's Hospital, Department of Anesthesia
Additional Information:
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Responsible Party: Stephan Malherbe, Associate Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT03749915    
Other Study ID Numbers: H18-02364
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Stephan Malherbe, University of British Columbia:
Pain Ease
Ametop Gel
Additional relevant MeSH terms:
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Tetracaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents