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Efficacy of Ametop Cream in Reducing Pain of Local Anesthetic Infiltration

NCT ID: NCT01864213

Last Updated: 2013-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-10-31

Brief Summary

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Ametop is a numbing cream used to ease the pain of having blood drawn or an IV inserted. It is safe and virtually none enters the blood stream. It's effectiveness at reducing the pain of the freezing injection prior to epidural/ spinal anesthesia in pregnant women has not been studied.

Detailed Description

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We propose to randomize 70 women to have either the numbing cream or a similar looking moisturizing cream placed on their lower back before their anesthetic. They will rate the discomfort of the freezing injection allowing us to compare the two groups and determine if the numbing cream is effective.

Conditions

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Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ametop cream

Group Type EXPERIMENTAL

Ametop cream

Intervention Type DRUG

Interventions

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Ametop cream

Intervention Type DRUG

Other Intervention Names

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amethocaine

Eligibility Criteria

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Inclusion Criteria

* Any pregnant subject undergoing an elective procedure under neuraxial anesthesia.

Exclusion Criteria

* Any contraindication to neuraxial anesthesia
* Subjects in labour
Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vit Gunka, MD FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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BC Women's Hospital

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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H13-00771

Identifier Type: -

Identifier Source: org_study_id