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Efficacy of Ametop Cream in Reducing Pain of Local Anesthetic Infiltration

Information source: University of British Columbia
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: Ametop cream (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: University of British Columbia

Official(s) and/or principal investigator(s):
Vit Gunka, MD FRCPC, Principal Investigator, Affiliation: University of British Columbia

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.

Clinical Details

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

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Health Services Research

Primary outcome: Pain score

Detailed 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.

Eligibility

Minimum age: 19 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

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

Exclusion Criteria:

- Any contraindication to neuraxial anesthesia

- Subjects in labour

Locations and Contacts

BC Women's Hospital, Vancouver, British Columbia V6H 3N1, Canada
Additional Information

Starting date: May 2013
Last updated: December 10, 2013

Page last updated: August 23, 2015

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