- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03638921
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 (NEPHROPAIN)
November 5, 2019 updated by: Rennes University Hospital
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Rennes, France, 35033
- Rennes University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MEOPA
Patients included in the study will receive MEOPA with a high concentration mask (bottle stored for at least 48 hours horizontally) at a minimum flow rate of 10 L / min under supervision of a health care worker after explanation of use to the patient in a quiet environment (box).
MEOPA will be administered for a maximum total duration of 20 minutes, continuously or not depending on the needs of the patient, but after a continuous phase at the beginning of treatment of at least 3 minutes.
|
Patients included in the study will receive MEOPA with a high concentration mask (bottle stored for at least 48 hours horizontally) at a minimum flow rate of 10 L / min under supervision of a health care worker after explanation of use to the patient in a quiet environment (box).
MEOPA will be administered for a maximum total duration of 20 minutes, continuously or not depending on the needs of the patient, but after a continuous phase at the beginning of treatment of at least 3 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numerical Rating Scale (NRS)
Time Frame: 20 minutes
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Analgesics consumption
Time Frame: 0, 20, 60, 240 minutes and through hospitalization completion (an average of a few hours)
|
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.
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0, 20, 60, 240 minutes and through hospitalization completion (an average of a few hours)
|
Adverse effects related to taking analgesics,
Time Frame: through treatment completion, an average of a few hours
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through treatment completion, an average of a few hours
|
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NRS average
Time Frame: 0, 20, 60, 240 minutes and through hospitalization completion (an average of a few hours)
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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)
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Hospitalization time
Time Frame: through hospitalizationcompletion, an average of a few hours
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Hospitalization time in emergency
|
through hospitalizationcompletion, an average of a few hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Etienne Paulhet, MD, Rennes University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2018
Primary Completion (Actual)
June 1, 2019
Study Completion (Actual)
June 1, 2019
Study Registration Dates
First Submitted
August 7, 2018
First Submitted That Met QC Criteria
August 17, 2018
First Posted (Actual)
August 20, 2018
Study Record Updates
Last Update Posted (Actual)
November 6, 2019
Last Update Submitted That Met QC Criteria
November 5, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 35RC17_8826_NEPHROPAIN Après
- 2018-001652-35 (EudraCT Number)
- 2018/38 (Other Identifier: CPP Est I (Dijon))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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