Renal ColicPhase 2NEPHROPAINNCT03638921
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
A Phase 2 study testing MEOPA in people with Renal Colic, run by Rennes University Hospital at 1 site in France.
Trial summary
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. 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?
- MEOPA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2018to 1 Jun 2019
- Phase
- Phase 2
- 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
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Renal Colic
- Being tested
- MEOPA
- Medical subject headings
- Renal Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEOPADrug
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.
| Study group | Role | What they receive |
|---|---|---|
| MEOPA | Experimental | 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. Receives: Drug: MEOPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 minutes
Secondary outcomes (4)
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.
Measured: 0, 20, 60, 240 minutes and through hospitalization completion (an average of a few hours)
Adverse effects related to taking analgesics,
Measured: through treatment completion, an average of a few hours
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).
Measured: 0, 20, 60, 240 minutes and through hospitalization completion (an average of a few hours)
Hospitalization time
Hospitalization time in emergency
Measured: through hospitalizationcompletion, an average of a few hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start1 Oct 2018
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- MEOPA
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Apicil
- Responsible party
- Sponsor
- Investigators
- Etienne Paulhet, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638921
- Sponsor's protocol ID
- 35RC17_8826_NEPHROPAIN Après
- Other IDs
- 2018-001652-35, 2018/38, 2018
- Acronym
- NEPHROPAIN
- Status last verified
- Nov 2019
- First submitted
- 7 Aug 2018
- Last updated
- 6 Nov 2019
- 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 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03638921
- Acronym / sponsor ID
- NEPHROPAIN / 35RC17_8826_NEPHROPAIN Après
- Conditions
- Renal Colic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- Fondation Apicil
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 20 Aug 2018 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- MEOPA
| Arm | Type | Receives |
|---|---|---|
| MEOPA | Experimental | Drug: MEOPAPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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)
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 |
|---|---|---|
| MEOPAPatients 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. | Drug | MEOPA |
Primary outcome
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.
4 secondary outcomes
Analgesics consumption
Time frame: 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
NRS average
Time frame: 0, 20, 60, 240 minutes and through hospitalization completion (an average of a few hours)
Hospitalization time
Time frame: through hospitalizationcompletion, an average of a few hours
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 6 Nov 2019.
- 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.
Etienne Paulhet, MD principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MEOPA in people with 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 4 inclusion and 10 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 6 Nov 2019. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Numerical Rating Scale (NRS) (time frame: 20 minutes). 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 6 Nov 2019.