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Ametop Compared to Ametop With Pain Ease Spray

NCT03749915 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2018-11-21

No results posted yet for this study

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.

Conditions

  • Analgesia
  • Topical Anesthetic

Interventions

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.

DRUG

Ametop

Tetracaine Hydrochloride Gel 4%

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Stephan Malherbe, FRCA · BC Children's Hospital, Department of Anesthesia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-20
Primary Completion
2019-12-31
Completion
2019-12-31
FDA Device
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03749915 on ClinicalTrials.gov