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Efficacy of Ametop Cream in Reducing Pain of Local Anesthetic Infiltration (Ametop)

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ClinicalTrials.gov Identifier: NCT01864213
Recruitment Status : Completed
First Posted : May 29, 2013
Last Update Posted : December 11, 2013
Sponsor:
Information provided by (Responsible Party):
University of British Columbia

Brief 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.

Condition or disease Intervention/treatment Phase
Pain Drug: Ametop cream Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
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 Start Date : May 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

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Arm Intervention/treatment
Experimental: Ametop cream Drug: Ametop cream
Other Name: amethocaine




Primary Outcome Measures :
  1. Pain score [ Time Frame: Within 5 minutes of spinal ]
    Patient will be asked to give a pain score



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Any contraindication to neuraxial anesthesia
  • Subjects in labour

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864213


Locations
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Canada, British Columbia
BC Women's Hospital
Vancouver, British Columbia, Canada, V6H 3N1
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Vit Gunka, MD FRCPC University of British Columbia

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Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01864213     History of Changes
Other Study ID Numbers: H13-00771
First Posted: May 29, 2013    Key Record Dates
Last Update Posted: December 11, 2013
Last Verified: December 2013
Additional relevant MeSH terms:
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Anesthetics
Tetracaine
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents