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)

• ClinicalTrials.gov Identifier: NCT03638921
• Recruitment Status: Completed
• First Posted: August 20, 2018
• Last Update Posted: November 6, 2019
• Sponsor: Rennes University Hospital
• Collaborator: Fondation Apicil
• Information provided by (Responsible Party): Rennes University Hospital

Study Description

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: N/A
• 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
• Actual Study Start Date: October 1, 2018
• Actual Primary Completion Date: June 1, 2019
• Actual Study Completion Date: June 1, 2019

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Locations

France

Rennes University Hospital

Rennes, France, 35033

Sponsors and Collaborators

Rennes University Hospital

Fondation Apicil

Investigators

• Principal Investigator: Etienne Paulhet, MD; Rennes University Hospital

More Information

• Responsible Party: Rennes University Hospital
• ClinicalTrials.gov Identifier: NCT03638921
• 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
• Last Update Posted: November 6, 2019
• Last Verified: November 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Additional relevant MeSH terms:

Colic; Emergencies; Renal Colic; Disease Attributes; Pathologic Processes; Infant, Newborn, Diseases; Pain; Neurologic Manifestations