An Analgesia Protocol for Acute Renal Colic in the Emerge... | NCT00504283

Studies
An Analgesia Protocol for Acute Renal Colic in the Emergency Department

NCT00504283

Sponsor

Dartmouth-Hitchcock Medical Center

Status

Completed

Last Update Posted

Oct 18, 2007Estimated

Enrollment

45Estimated

Phase

Not Applicable

Conditions

Kidney Stone

Interventions

Toradol
Morphine

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

Oct 2007

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

Feb 2007

Primary Completion Date

Not provided

Completion Date

Oct 2007Actual

First Submitted Date

Jul 17, 2007

First Submission Date that Met QC Criteria

Jul 18, 2007

First Posted Date

Jul 19, 2007Estimated

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

Oct 17, 2007

Last Update Posted Date

Oct 18, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

An analgesia protocol for acute renal colic will lead to faster significant reductions in pain than prior practice.

Detailed Description

A retrospective study was performed that assessed the time to significant analgesia and medications used to achieve analgesia in the DHMC ED. Based upon this a prospective pain management protocol was designed and we will track the difference in time to significant pain relief between the two groups.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Estimated

Measure	Description	Time Frame
Time to significant pain relief		Within emergency department

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Kidney stone on stone protocol CT scan
Acute pain from a kidney stone

Exclusion Criteria:

Age < 18 or > 65
Pregnant women
Contraindications to NSAID's or opiates

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter L Steinberg, MD	DHMC dept of Urology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
DHMC		Lebanon	New Hampshire	03756	United States

Condition Browse Module

MeSH Terms

ID	Term
D007669	Kidney Calculi
D056844	Renal Colic
D010146	Pain
D004630	Emergencies

Ancestor Terms

ID	Term
D053040	Nephrolithiasis
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020911	Ketorolac Tromethamine
D009020	Morphine

Ancestor Terms

ID	Term
D007213	Indomethacin
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Toradol	Drug
Morphine	Drug