Renal ColicNEPHROPAINNCT03278652
Use of Analgesic Drugs in Renal Colic in Emergency Room
An observational study of Renal Colic, run by Rennes University Hospital at 1 site in France.
Trial summary
A prospective non-interventional study on the use of analgesic drugs in renal colic in emergency rooms Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Colic
- What is being tested?
- Consumption of drugs for analgesic use
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 19 Apr 2016to 31 Dec 2017
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with renal colic
Who may be able to join
- Patients older than 18 years old
- Suspicion of renal colic (pain in a lumbar pit radiating to the external genital organs, rapidly progressive onset, non-febrile)
Who cannot join
- Shock
- Glasgow score less than 15
- Oxygen saturation less than 93% in ambient air
- Signs of intracranial hypertension (headache associated with vomiting)
- Suspicion of pneumothorax
- History of emphysema or chronic obstructive pulmonary disease
Show all 11Show fewer
- Diving accident or suspicion of gas embolism
- Trauma of the face of interest in the area of application of the mask
- Abdominal gas distension
- Contraindication in Nonsteroidal anti-inflammatory drugs
- Pregnancy
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Rennes
Rennes, 35033
Alexandre Tanneau, MD, 02.99.28.60.48, alexandre.tanneau@chu-rennes.fr
About this study
A prospective non-interventional study on the use of analgesic drugs in renal colic in emergency rooms
- Conditions
- Renal Colic
- Being tested
- Consumption of drugs for analgesic use
- Medical subject headings
- Renal Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consumption of drugs for analgesic useOther
- Regular assessment of pain
- Drug data will be collected (name, dosage, route of administration, time of delivery)
| Study group | Role | What they receive |
|---|---|---|
| Patient with renal colic | Not described Receives: Other: Consumption of drugs for analgesic use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of analgesic drug used in the context of renal colic in emergency rooms by following the recommended and validated service protocol
Collection of name, dosage, route of administration, time of issue of the drug
Measured: During hospitalisation in emergency rooms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start19 Apr 2016
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ColicStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03278652
- Sponsor's protocol ID
- 35RC16_3033_NEPHROPAIN
- Acronym
- NEPHROPAIN
- Status last verified
- Sep 2017
- First submitted
- 5 Sep 2017
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Analgesic Drugs in Renal Colic in Emergency Room
- ClinicalTrials.gov ID
- NCT03278652
- Acronym / sponsor ID
- NEPHROPAIN / 35RC16_3033_NEPHROPAIN
- Conditions
- Renal Colic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 19 Apr 2016 (actual)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 11 Sep 2017 (actual)
- 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.
A prospective non-interventional study on the use of analgesic drugs in renal colic in emergency rooms
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with renal colic | – | Other: Consumption of drugs for analgesic use |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with renal colic
Key inclusion criteria (2 listed)
- Patients older than 18 years old
- Suspicion of renal colic (pain in a lumbar pit radiating to the external genital organs, rapidly progressive onset, non-febrile)
Key exclusion criteria (11 listed)
- Shock
- Glasgow score less than 15
- Oxygen saturation less than 93% in ambient air
- Signs of intracranial hypertension (headache associated with vomiting)
- Suspicion of pneumothorax
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 |
|---|---|---|
| Consumption of drugs for analgesic use* Regular assessment of pain * Drug data will be collected (name, dosage, route of administration, time of delivery) | Other | Patient with renal colic |
Primary outcome
Number of analgesic drug used in the context of renal colic in emergency rooms by following the recommended and validated service protocol
Time frame: During hospitalisation in emergency rooms
Collection of name, dosage, route of administration, time of issue of the drug
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Colic, run by Rennes University Hospital at 1 site in France.
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 11 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: status not confirmed, as of the sponsor's last update on 11 Sep 2017. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandre Tanneau, MD (02.99.28.60.48, alexandre.tanneau@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of analgesic drug used in the context of renal colic in emergency rooms by following the recommended and validated service protocol (time frame: During hospitalisation in emergency rooms). 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 11 Sep 2017; AzTrials last refreshed its copy on 8 Nov 2026.