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
About this trial
This is an interventional treatment trial for Kidney Stone focused on measuring Renal colic, pain, protocol, emergency department
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
Sites / Locations
- DHMC
Outcomes
Primary Outcome Measures
Time to significant pain relief
Secondary Outcome Measures
Full Information
NCT ID
NCT00504283
First Posted
July 17, 2007
Last Updated
October 17, 2007
Sponsor
Dartmouth-Hitchcock Medical Center
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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