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NCT01864213 Clinical Trial

Efficacy of Ametop Cream in Reducing Pain of Local Anesthetic Infiltration

Pain Clinical Trial

— Ametop  

Official title:
The Efficacy of Topical Amethocaine Gel in Reducing the Pain of Local Anesthetic Infiltration Prior to Neuraxial Anesthesia in Non-labouring Pregnant Women: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01864213
Other study ID # H13-00771
Secondary ID
Status Completed
Phase Phase 1
First received May 9, 2013
Last updated December 10, 2013
Start date May 2013
Est. completion date October 2013

Study information
Verified date December 2013
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 78
Est. completion date October 2013
Est. primary completion date October 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 19 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Any contraindication to neuraxial anesthesia

- Subjects in labour

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ametop cream

Locations
Country Name City State
Canada BC Women's Hospital Vancouver British Columbia

Sponsors (1)
Lead Sponsor Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain score Patient will be asked to give a pain score Within 5 minutes of spinal
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