- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03749915
Ametop Compared to Ametop With Pain Ease Spray
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Stephan Malherbe, FRCA
- Phone Number: 604-875-2711
- Email: smalherbe@cw.bc.ca
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z 4V4
- BC Children's Hospital - Department of Anesthesia
-
Contact:
- Stephan Malherbe, MBBS, FRCA
- Phone Number: 604-875-2711
- Email: smalherbe@cw.bc.ca
-
Principal Investigator:
- Stephan Malherbe, FRCA
-
Sub-Investigator:
- Louis Scheepers, FRCA
-
Sub-Investigator:
- Zoe Brown, FRCA
-
Sub-Investigator:
- Robert Purdy, FRCA
-
Sub-Investigator:
- Eleanor Reimer, FRCA
-
Sub-Investigator:
- Rachelle Scheepers
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Comparator: Ametop only
Ametop Gel applied as sole topical anesthetic.
|
Tetracaine Hydrochloride Gel 4%
Other Names:
|
EXPERIMENTAL: Intervention: Pain Ease Cold Spray
Pain Ease Cold spray applied immediately before IV insertion, as an adjunct to Ametop Gel.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
intraoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insertion attempts
Time Frame: intraoperative
|
Total number of insertion attempts required for successful placement of IV cannula
|
intraoperative
|
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.
|
intraoperative
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stephan Malherbe, FRCA, BC Children's Hospital, Department of Anesthesia
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H18-02364
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Analgesia
-
Tanta UniversityRecruiting
-
Damanhour Teaching HospitalRecruiting
-
SSM Health Bone and Joint Hospital at St AnthonyRecruitingAnalgesiaUnited States
-
Mansoura UniversityRecruiting
-
Makassed General HospitalRecruiting
-
Centre Hospitalier Universitaire de NīmesRecruiting
-
Ataturk UniversityCompleted
-
Abd-Elazeem Abd-Elhameed ElbakryActive, not recruiting
Clinical Trials on Ametop
-
KK Women's and Children's HospitalCompleted
-
University of British ColumbiaCompleted
-
Nottingham University Hospitals NHS TrustCompleted
-
Mount Sinai Hospital, CanadaStriving for Excellence Fund, Mount Sinai HospitalCompleted
-
Fraser HealthCompleted
-
University of WashingtonUpsher-Smith LaboratoriesCompleted
-
Lawson Health Research InstituteWithdrawn
-
University of CalgaryCompletedCognitive Change | BehaviorCanada