Cohort Comparison of Dental Nerve Block With Other Forms... | NCT01268436

Studies
Cohort Comparison of Dental Nerve Block With Other Forms of Analgesia in Alleviating the Pain of Toothache

NCT01268436

Sponsor

Albany Medical College

Status

Completed

Last Update Posted

Mar 24, 2014Estimated

Enrollment

64Actual

Phase

Not provided

Conditions

Tooth Pain

Interventions

Not provided

Countries

United States

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

No data available

No data is available for this block.

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 2010

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

Jan 2010

Primary Completion Date

Nov 2012Actual

Completion Date

Nov 2012Actual

First Submitted Date

Dec 29, 2010

First Submission Date that Met QC Criteria

Dec 29, 2010

First Posted Date

Dec 30, 2010Estimated

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

Mar 20, 2014

Last Update Posted Date

Mar 24, 2014Estimated

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

Toothache is a common source of pain for Emergency Department patients. There are several common ways to control the pain of toothache. But we do not know if any one of them is more effective than another. It is also possible that how we take care of your pain in the Emergency Department will influence the level of pain you experience one or two days from now. This study seeks to answer these questions.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Injectable pain medication		Patients who receive an injectable form of pain medication.
Oral pain medication		Patients who receive oral pain medication only

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual Analog Pain Scale	Is there any change in patient report of pain using the Visual Analog Pain Scale before and after treatment.	Before and After treatment of tooth pain

Secondary Outcomes

Measure	Description	Time Frame
Need for additional treatment	Does patient require addtional/repeated analgesia or rescue medication?	while in the Emergency Department

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

> 18 years, pain in any tooth

Exclusion Criteria:

duration of pain > 96 hours
oral trauma within 96 hours of presentation
facial or neck swelling
pericoronitis
visual impairment to less than finger counting within three feet

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients identified by ED providers as having dental pain will be screened for enrollment.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Albany Medical Center		Albany	New York	12208	United States

Condition Browse Module

MeSH Terms

ID	Term
D014098	Toothache

Ancestor Terms

ID	Term
D014076	Tooth Diseases
D009057	Stomatognathic Diseases
D005157	Facial Pain
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided