Efficacy of Ametop Cream in Reducing Pain of Local Anesthetic Infiltration
Ametop
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
1 other identifier
interventional
78
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 pain
Started May 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 9, 2013
CompletedFirst Posted
Study publicly available on registry
May 29, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedDecember 11, 2013
December 1, 2013
5 months
May 9, 2013
December 10, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Pain score
Patient will be asked to give a pain score
Within 5 minutes of spinal
Study Arms (1)
Ametop cream
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Any pregnant subject undergoing an elective procedure under neuraxial anesthesia.
You may not qualify if:
- Any contraindication to neuraxial anesthesia
- Subjects in labour
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
BC Women's Hospital
Vancouver, British Columbia, V6H 3N1, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vit Gunka, MD FRCPC
University of British Columbia
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2013
First Posted
May 29, 2013
Study Start
May 1, 2013
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
December 11, 2013
Record last verified: 2013-12