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

Phase 2

Completed

• Conditions: Renal Colic
• Interventions: Drug: MEOPA

• Registration Number: NCT03638921
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-07
• Study First Submitted QC: 2018-08-17
• Study First Posted: 2018-08-20
• Study Start: 2018-10-01
• Primary Completion: 2019-06-01
• Study Completion: 2019-06-01
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-05
• Last Update Posted: 2019-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MEOPA	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

Name	Time	Method
Numerical Rating Scale (NRS)	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

Name	Time	Method
Analgesics consumption	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.
Hospitalization time	through hospitalizationcompletion, an average of a few hours	Hospitalization time in emergency
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)	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).

Trial Locations

Locations (1)

Rennes University Hospital; 🇫🇷 Rennes, France