Kidney StoneNCT00504283
An Analgesia Protocol for Acute Renal Colic in the Emergency Department
A study testing Toradol and Morphine in people with Kidney Stone, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
An analgesia protocol for acute renal colic will lead to faster significant reductions in pain than prior practice. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Kidney Stone
- What is being tested?
- Toradol and Morphine
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Oct 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Kidney stone on stone protocol CT scan
- Acute pain from a kidney stone
Who cannot join
- Age < 18 or > 65
- Pregnant women
- Contraindications to NSAID's or opiates
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Analgesia Protocol for Acute Renal Colic in the DHMC Emergency Department
An analgesia protocol for acute renal colic will lead to faster significant reductions in pain than prior practice.
Read the 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.
- Conditions
- Kidney Stone
- Being tested
- Toradol, Morphine
- Keywords
- Renal colic, pain, protocol, emergency department
- Medical subject headings
- Kidney Calculi, Renal Colic, Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToradolDrug
MorphineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to significant pain relief
Measured: Within emergency department
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2007 (estimated)
- Study startFeb 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Peter L Steinberg, MD, Principal investigator, DHMC dept of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00504283
- Sponsor's protocol ID
- CPHS 20569
- Status last verified
- Oct 2007
- First submitted
- 17 Jul 2007
- Last updated
- 18 Oct 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Analgesia Protocol for Acute Renal Colic in the DHMC Emergency Department
- ClinicalTrials.gov ID
- NCT00504283
- Acronym / sponsor ID
- CPHS 20569
- Conditions
- Kidney Stone
- Keywords
- Renal colic, pain, protocol, emergency department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- Feb 2007
- Study completion
- Oct 2007 (actual)
- First posted
- 19 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Kidney stone on stone protocol CT scan
- Acute pain from a kidney stone
Key exclusion criteria (3 listed)
- Age < 18 or > 65
- Pregnant women
- Contraindications to NSAID's or opiates
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toradol | Drug | – |
| Morphine | Drug | – |
Primary outcome
Time to significant pain relief
Time frame: Within emergency department
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter L Steinberg, MD principal investigator
DHMC dept of Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toradol and Morphine in people with Kidney Stone, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to significant pain relief (time frame: Within emergency department). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2007.