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An Analgesia Protocol for Acute Renal Colic in the Emergency Department

Primary Purpose

Kidney Stone

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Toradol
Morphine
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Stone focused on measuring Renal colic, pain, protocol, emergency department

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • DHMC

Outcomes

Primary Outcome Measures

Time to significant pain relief

Secondary Outcome Measures

Full Information

First Posted
July 17, 2007
Last Updated
October 17, 2007
Sponsor
Dartmouth-Hitchcock Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00504283
Brief Title
An Analgesia Protocol for Acute Renal Colic in the Emergency Department
Official Title
An Analgesia Protocol for Acute Renal Colic in the DHMC Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Dartmouth-Hitchcock Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stone
Keywords
Renal colic, pain, protocol, emergency department

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Toradol
Intervention Type
Drug
Intervention Name(s)
Morphine
Primary Outcome Measure Information:
Title
Time to significant pain relief
Time Frame
Within emergency department

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter L Steinberg, MD
Organizational Affiliation
DHMC dept of Urology
Official's Role
Principal Investigator
Facility Information:
Facility Name
DHMC
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States

12. IPD Sharing Statement

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An Analgesia Protocol for Acute Renal Colic in the Emergency Department

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