Back to results35RC17_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)
Primary Purpose
Renal Colic
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
MEOPA
Sponsored by
About this trial
This is an interventional treatment trial for Renal Colic
Eligibility 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.
Sites / Locations
- Rennes University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MEOPA
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Adverse effects related to taking analgesics,
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).
Hospitalization time
Hospitalization time in emergency
Full Information
NCT ID
NCT03638921
First Posted
August 7, 2018
Last Updated
November 5, 2019
Sponsor
Rennes University Hospital
Collaborators
Fondation Apicil
1. Study Identification
Unique Protocol Identification Number
NCT03638921
Brief 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
Acronym
NEPHROPAIN
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
Collaborators
Fondation Apicil
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Colic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
MEOPA
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MEOPA
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
MEOPA
Intervention Description
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 Measure Information:
Title
Numerical Rating Scale (NRS)
Description
Pain Ealuation. Score : 0 to 10. Proportion of individuals whose initial pain evaluation (Digital Scale) is divided by at least two to T20.
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Analgesics consumption
Description
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.
Time Frame
0, 20, 60, 240 minutes and through hospitalization completion (an average of a few hours)
Title
Adverse effects related to taking analgesics,
Time Frame
through treatment completion, an average of a few hours
Title
NRS average
Description
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).
Time Frame
0, 20, 60, 240 minutes and through hospitalization completion (an average of a few hours)
Title
Hospitalization time
Description
Hospitalization time in emergency
Time Frame
through hospitalizationcompletion, an average of a few hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Etienne Paulhet, MD
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rennes University Hospital
City
Rennes
ZIP/Postal Code
35033
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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