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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)

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ClinicalTrials.gov Identifier: NCT03638921
Recruitment Status : Not yet recruiting
First Posted : August 20, 2018
Last Update Posted : August 20, 2018
Sponsor:
Collaborator:
Fondation Apicil
Information provided by (Responsible Party):
Rennes University Hospital

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Renal Colic Drug: MEOPA Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Intervention Model Description: MEOPA
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

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.
Drug: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Adverse effects related to taking analgesics, [ Time Frame: through treatment completion, an average of a few hours ]
  3. NRS average [ Time Frame: 0, 20, 60, 240 minutes and through hospitalization completion (an average of a few hours) ]

    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).


  4. Hospitalization time [ Time Frame: through hospitalizationcompletion, an average of a few hours ]
    Hospitalization time in emergency



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03638921


Contacts
Contact: Etienne Paulhet, MD 0033299284321 etienne.paulhet@chu-rennes.fr
Contact: Cédric Gangloff, MD 0033299284321 cedric.gangloff@chu-rennes.fr

Locations
France
Rennes University Hospital Not yet recruiting
Rennes, France, 35033
Contact: Etienne Paulhet, MD         
Principal Investigator: Etienne Paulhet, MD         
Sponsors and Collaborators
Rennes University Hospital
Fondation Apicil
Investigators
Principal Investigator: Etienne Paulhet, MD Rennes University Hospital

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03638921     History of Changes
Other Study ID Numbers: 35RC17_8826_NEPHROPAIN Après
2018-001652-35 ( EudraCT Number )
2018/38 ( Other Identifier: CPP Est I (Dijon) )
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: TO DEFINE

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Emergencies
Colic
Renal Colic
Disease Attributes
Pathologic Processes
Infant, Newborn, Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms