Status:
UNKNOWN
Ametop Compared to Ametop With Pain Ease Spray
Lead Sponsor:
University of British Columbia
Conditions:
Analgesia
Topical Anesthetic
Eligibility:
All Genders
5-16 years
Phase:
NA
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 adj...
Eligibility Criteria
Inclusion
- ASA I \& II
- Elective day case procedure requiring an IV
Exclusion
- 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
Key Trial Info
Start Date :
November 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2019
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT03749915
Start Date
November 20 2018
End Date
December 31 2019
Last Update
November 21 2018
Active Locations (1)
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1
BC Children's Hospital - Department of Anesthesia
Vancouver, British Columbia, Canada, V5Z 4V4