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

NCT03638921 | Completed Phase 2

• 3 other identifiers: 35RC17_8826_NEPHROPAIN Après2018-001652-352018/38
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Colic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Analgesics consumption

  0, 20, 60, 240 minutes and through hospitalization completion (an average of a few hours)

• Adverse effects related to taking analgesics,

  through treatment completion, an average of a few hours

• NRS average

  0, 20, 60, 240 minutes and through hospitalization completion (an average of a few hours)

• Hospitalization time

  through hospitalizationcompletion, an average of a few hours

Study Arms (1)

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.

Drug: MEOPA

Interventions

MEOPA DRUG

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.

MEOPA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rennes University Hospital: lead
• Fondation Apicil: collaborator

Study Sites (1)

Rennes University Hospital

Rennes, 35033, France

Location

MeSH Terms

Conditions

Renal Colic

Interventions

Meopa

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Etienne Paulhet, MD

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: MEOPA

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: August 20, 2018
• Study Start: October 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: November 6, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)