Efficacy of Ametop Cream in Reducing Pain of Local Anesth... | NCT01864213

Studies
Efficacy of Ametop Cream in Reducing Pain of Local Anesthetic Infiltration

NCT01864213

Sponsor

University of British Columbia

Status

Completed

Last Update Posted

Dec 11, 2013Estimated

Enrollment

78Actual

Phase

Phase 1

Conditions

Pain

Interventions

Ametop cream

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

Oct 2013Actual

Completion Date

Oct 2013Actual

First Submitted Date

May 9, 2013

First Submission Date that Met QC Criteria

May 23, 2013

First Posted Date

May 29, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2013

Last Update Posted Date

Dec 11, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

78Actual

Label	Type	Description	Intervention Names
Ametop cream	Experimental		Drug: Ametop cream

Name	Type	Description	Arm Group Labels	Other Names
Ametop cream	Drug		Ametop cream	amethocaine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain score	Patient will be asked to give a pain score	Within 5 minutes of spinal

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any pregnant subject undergoing an elective procedure under neuraxial anesthesia.

Exclusion Criteria:

Any contraindication to neuraxial anesthesia
Subjects in labour

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vit Gunka, MD FRCPC	University of British Columbia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
BC Women's Hospital		Vancouver	British Columbia	V6H 3N1	Canada

Type	Date	Date Unknown
Release	Apr 27, 2017
Reset	Aug 4, 2017

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 27, 2017			Aug 4, 2017

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013748	Tetracaine

Ancestor Terms

ID	Term
D062366	para-Aminobenzoates
D062365	Aminobenzoates
D001565	Benzoates
D000146	Acids, Carbocyclic

Browse Leaves

Not provided

Browse Branches

Not provided