Renal Colic Clinical Trial
— NEPHROPAINOfficial title:
35RC17_8826_NEPHROPAIN Phase APRES : Interest of the Equimolar Oxygen Nitride Mixture (MEOPA) in the Treatment of Pain in Patients Presenting to the Emergency Department for Suspected Renal Colic: a Study BEFORE AFTER
Verified date | November 2019 |
Source | Rennes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
MEOPA (Equimolar Oxygen-Nitrogen Protoxide Mix) is a gas used in emergencies for short-term painful acts. It is often very effective with an analgesic, anxiolytic and muscle relaxant action. It is often combined with other analgesic medicines. It has already been proven in emergency medicine for short-term pain and trauma. It seems that it could be used more particularly for pains of medical origin. A study has already proved its effectiveness in the treatment of migraines in emergencies. The first phase of the NEPHROPAIN study began in 2016 after a favorable opinion from the Regional Ethics Committee. NEPHROPAIN phase AVANT was a prospective non-interventional study on the use of analgesic drugs in nephritic colic in emergencies by Dr. Alexandre Tanneau. This study was conducted at the University Hospital of Rennes and included 60 patients admitted to the emergency department for suspected renal colic. It made it possible to recruit the control group of the NEPHROPAIN study. Its main objective was to describe the suspected population of renal colic in Rennes emergencies, to determine NEPHROPAIN's primary endpoint and the number of NEPHROPAIN needed subjects.
Status | Completed |
Enrollment | 60 |
Est. completion date | June 1, 2019 |
Est. primary completion date | June 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria : - Age greater than or equal to 18, - Presenting a suspicion of renal colic, that is to say a pain at the level of a lumbar fossa radiating towards the external genital organs, of rapidly progressive, non-febrile appearance, - Having given free, informed and written consent, - Affiliated to the social security system. Exclusion Criteria : - Patient in shock of all types, defined here as an acute cardio-circulatory failure with mean arterial pressure less than 65 mm Hg. - Oxygen saturation below 93% in ambient air, - With suspicion of pneumothorax, - Having a history of emphysema and / or COPD (chronic obstructive pulmonary disease), - Contraindications to the administration of MEOPA: Patients requiring ventilation in pure oxygen; Intracranial hypertension (headache associated with jet vomiting); Any alteration of the state of consciousness, preventing the cooperation of the patient (Glasgow score less than 15); Head trauma; Pneumothorax; Emphysema bubbles; Gas embolism; Diving accident; Abdominal gas distension; Patient who has recently received an ophthalmic gas (SF6, C3F8, C2F6) used in ocular surgery as long as a gas bubble persists inside the eye and at least for a period of 3 months; Known and unsubstituted deficiency of vitamin B12 or folic acid; Neurological abnormalities of recent appearance and unexplained) - Contraindication to NSAIDs, - Patient treated in the long course by analgesic stage 3, - Pregnant or lactating woman, - Concomitant participation in another research involving the interventional or minimal risk and minimal human person, - Major persons subject to legal protection (legal safeguards, guardianship, tutorship) and persons deprived of their liberty. |
Country | Name | City | State |
---|---|---|---|
France | Rennes University Hospital | Rennes |
Lead Sponsor | Collaborator |
---|---|
Rennes University Hospital | Fondation Apicil |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Numerical Rating Scale (NRS) | Pain Ealuation. Score : 0 to 10. Proportion of individuals whose initial pain evaluation (Digital Scale) is divided by at least two to T20. | 20 minutes | |
Secondary | Analgesics consumption | Proportion of individuals who used analgesics between T0 and T20, between T20 and T60, between T60 and T240, and between T240 and at the end of hospitalization. | 0, 20, 60, 240 minutes and through hospitalization completion (an average of a few hours) | |
Secondary | Adverse effects related to taking analgesics, | through treatment completion, an average of a few hours | ||
Secondary | NRS average | Pain average (digital scale) at T0 (before administration of the first analgesic, MEOPA or other), T20, T60, T240, and at at the end of hospitalization. Average of NRS score (pain evaluation, score : 0 to 10). |
0, 20, 60, 240 minutes and through hospitalization completion (an average of a few hours) | |
Secondary | Hospitalization time | Hospitalization time in emergency | through hospitalizationcompletion, an average of a few hours |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT01685658 -
Intravenous Paracetamol Versus Ketoprofen When Treating Renal Colic in Emergency Situations
|
Phase 4 | |
Completed |
NCT01349244 -
Hydronephrosis on Ultrasound With CT Finding in Patients With Renal Colic
|
N/A | |
Recruiting |
NCT04169555 -
"Point of Care" Ultrasound and Renal Colic
|
N/A | |
Completed |
NCT04160520 -
Pramipexole and Morphine for Renal Colic
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT04080973 -
Metabolic Workup in Patients Suffering From Kidney Stone Disease and Osteopenia
|
N/A | |
Completed |
NCT01979042 -
Urinary Markers for Unilateral Kidney Obstruction
|
N/A | |
Completed |
NCT03865004 -
Combination Trial of Intravenous Paracetamol - Morphine for Treating Acute Renal Colic in Emergency Setting: An Optimum Treatment
|
Phase 4 | |
Completed |
NCT03706404 -
Renal Colic Fast Track Pathway in the Emergency Department.
|
N/A | |
Completed |
NCT03665753 -
Comparison of IV 10, 20, and 30mg for Renal Colic Pain in the ED
|
Early Phase 1 | |
Not yet recruiting |
NCT05150899 -
Role of Antihistaminic in Acute Renal Colic Prevent Pain Recurrence and Expulsion of Ureteric Stone ≤ 1cm
|
||
Recruiting |
NCT03790514 -
Heat Wrap for Renal Colic
|
N/A | |
Completed |
NCT00646061 -
Pain Control in Renal Colic
|
Phase 1 | |
Completed |
NCT05653401 -
Treatment of Renal Colic in the Emergency Department: Comparison Between Magnesium Sulfate and Lidocaine.
|
Phase 2 | |
Not yet recruiting |
NCT02782273 -
Morphine Versus Ketorolac in Renal Colic
|
Phase 4 | |
Completed |
NCT01352676 -
Limit Computed Tomography (CT) Scanning in Suspected Renal Colic
|
||
Not yet recruiting |
NCT06412900 -
Radiomics and Image Segmentation of Urinary Stones by Artificial Intelligence
|
||
Not yet recruiting |
NCT06342648 -
Intracutaneous Sterile Water and Diclofenac Sodium Injections in Renal Colic
|
N/A | |
Recruiting |
NCT03137498 -
Lidocaine vs Ketorolac for Management of Renal Colic in the Emergency Department
|
Phase 4 | |
Recruiting |
NCT01742689 -
Analgesic Efficacy of Intranasal Desmopressin in Acute Renal Colic
|
Phase 3 | |
Completed |
NCT01546701 -
Buprenorphine in Acute Renal Colic Pain Management
|
Phase 4 |