- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02198378
Comparison of MEOPA + Paracetamol Versus Morphine Treatment in Acute Coronary Syndrome Analgesia. (SCADOLII)
Analgesia of Acute Coronary Syndromes With ST-segment Elevation in a Pre-hospital Setting. Randomized Non-inferiority Trial of the Association MEOPA + Paracetamol Versus Morphine.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The investigators wish to compare the use of morphine according to current recommendations with the use of MEOPA associated with intravenous paracetamol in the management of patients with STEMI. The investigators hypothesize that the association of MEOPA and paracetamol, which is easy to use in a pre-hospital setting, will give patients pain relief as effectively as morphine.
This alternative treatment would avoid the use of morphine, whose potentially damaging consequences on myocardial function have been suggested by experimental studies and by an observational study. The physician of the mobile emergency team (SMUR) verifies the inclusion and non- inclusion criteria for the study. The patient must present STEMI defined in accordance with the recommendations and chest pain of intensity ≥ 4 on the NRS. The specific treatment for STEMI will be given before inclusion in the study, with the exception of analgesic treatment. In particular, inclusion in the study must not delay the initiation of strategies of recanalization and reperfusion.
The SMUR physician in charge of the patient will administer the treatment defined by randomization.
After 30 minutes, the patient will be managed in accordance with the recommendations and will be hospitalized, generally in a cardiology intensive care unit. At one month, the clinical research technician will record the patient's vital status and collect the patient's hospital records.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Agen, France
- Centre Hospitalier d'Agen
-
Besançon, France
- Centre Hospitalier Jean Minjoz
-
Bobigny, France
- CHU Avicenne
-
Bordeaux, France
- Hôpital Pellegrin
-
Bourg-en-Bresse, France
- Centre Hospitalier Bourg-en-Bresse
-
Chambéry, France
- Centre Hospitalier de Chambéry
-
Chartres, France
- Centre Hospitalier Louis Pasteur
-
Chateauroux, France
- Centre Hospitalier Chateauroux
-
Clermont-Ferrand, France
- Chu D'Estaing
-
Clichy, France
- Centre Hospitalier Beaujon
-
Contamine sur Arve, France
- Centre Hospitalier Alpes Léman
-
Corbeil-Essonnes, France
- Centre Hospitalier Sud Francilien
-
Dijon, France
- Centre Hospitalier Dijon
-
Foix, France
- Centre Hospitalier du Val d'Ariège
-
Garches, France
- Centre Hospitalier Raymond Poincaré
-
Grenoble, France
- Centre Hospitalier de Grenoble
-
La Roche-sur-Yon, France
- Centre Hospitalier Départemental La Roche/Yon
-
Lille, France
- CHRU Lille
-
Limoges, France
- Chu Dupuytren
-
Lyon, France
- Centre Hospitalier Edouard Herriot
-
Marseille, France
- Centre Hospitalier de la Timone
-
Melun, France
- Centre Hospitalier Marc Jacquet
-
Metz, France
- CHR Bon Secours
-
Montpellier, France
- CHRU Montpellier
-
Nancy, France
- CHU Nancy
-
Nantes, France
- CHU Nantes
-
Nice, France
- Centre Hospitalier de Nice
-
Paris, France
- Centre Hospitalier Necker
-
Paris, France
- Centre Hospitalier Pitié-Salpétrière
-
Paris, France
- Groupe hospitamier Lariboisière-Fernand Widal-St-Louis
-
Poitiers, France
- CHU Poitiers
-
Pontoise, France
- Centre Hospitalier Rene Dubos
-
Pringy, France
- Centre Hospitalier Annecy-Gennevois
-
Saint-Gaudens, France
- Centre Hospitalier COMMINGES PYRENEES
-
Toulon, France
- Centre Hospitalier Poulon la Seyne-sur-mer
-
Toulouse, France
- CHU Toulouse
-
Tours, France
- CHRU Tours
-
Valence, France
- Centre Hospitalier de Valence
-
Vienne, France
- Centre Hospitalier Lucien Hussel
-
-
-
-
-
Saint-Denis, Réunion
- CHU Felix Guyon
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient with STEMI < 12 h treated before hospital admission and pain ≥ 4 on the numerical rating scale.
Exclusion Criteria:
- Acute severe hemodynamic, respiratory or neurological failure
- Heart failure: Killip class III and IV
- Known allergy to morphine or nitrous oxide
- Patient who has already received morphine or MEOPA before the arrival of the hospital team during the 4 hours preceding the pre-hospital intervention
- Contraindications to nitrous oxide
- Patient unable to assess pain intensity on the numerical rating scale
- Patient under legal guardianship
- Pregnancy
- Patient transported by air ambulance
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Morphine
Morphine group: administration of morphine will start with a 0.05 mg/kg bolus followed by reinjection of 2 mg every 5 minutes until effective analgesia is obtained, defined as NRS ≤ 3.
|
Bolus of 2 mg intravenously if EN = 4 or 5 and 3 mg bolus if EN> 6 followed by reinjection of 2mg every 5 minutes until effective analgesia.
Other Names:
|
Experimental: MEOPA and paracetamol
The patient will be equipped with a facemask delivering MEOPA.The gas flow received by the patient is adapted to his/her ventilation. During the same time, an intravenous injection of 1 g paracetamol will be administered. |
The patient will be equipped with a facemask after he/she has been informed.
The facemask is adapted to the patient.
The patient breathes normally in the mask which is held in place by a member of the SMUR team who has received previous training in use of MEOPA.
The gas flow received by the patient is adapted to his/her ventilation.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effective analgesia (NRS score≤ 3) at 30 minutes after the start of analgesia
Time Frame: 30 minutes after randomisation.
|
The primary outcome measure is effective analgesia, defined by the consensus conference as an NRS score ≤ 3 at 30 minutes after the start of analgesia.
|
30 minutes after randomisation.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse event
Time Frame: all 5 minutes during 30 minutes
|
Occurrence of an adverse effect, in particular, respiratory depression (RR, respiratory rate < 10 cycles par minute or respiratory score ≥ R1), nausea, vomiting, sedation (sedation scale (EDS) score ≥2), dizziness, pruritus.
|
all 5 minutes during 30 minutes
|
NRS distribution
Time Frame: 30 minutes after randomization
|
Distribution of the NRS at 30 minutes and on arrival at the cardiology unit
|
30 minutes after randomization
|
Effective analgesia
Time Frame: all 5 minutes during 30 minutes
|
The time of effective analgesia will be defined for each subject
|
all 5 minutes during 30 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sandrine Charpentier, PH,MD, CHU Toulouse
Publications and helpful links
General Publications
- Myocardial infarction redefined--a consensus document of The Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction. Eur Heart J. 2000 Sep;21(18):1502-13. doi: 10.1053/euhj.2000.2305.
- Van de Werf F, Bax J, Betriu A, Blomstrom-Lundqvist C, Crea F, Falk V, Filippatos G, Fox K, Huber K, Kastrati A, Rosengren A, Steg PG, Tubaro M, Verheugt F, Weidinger F, Weis M; ESC Committee for Practice Guidelines (CPG). Management of acute myocardial infarction in patients presenting with persistent ST-segment elevation: the Task Force on the Management of ST-Segment Elevation Acute Myocardial Infarction of the European Society of Cardiology. Eur Heart J. 2008 Dec;29(23):2909-45. doi: 10.1093/eurheartj/ehn416. Epub 2008 Nov 12. No abstract available.
- Canadian Cardiovascular Society; American Academy of Family Physicians; American College of Cardiology; American Heart Association, Antman EM, Hand M, Armstrong PW, Bates ER, Green LA, Halasyamani LK, Hochman JS, Krumholz HM, Lamas GA, Mullany CJ, Pearle DL, Sloan MA, Smith SC Jr, Anbe DT, Kushner FG, Ornato JP, Pearle DL, Sloan MA, Jacobs AK, Adams CD, Anderson JL, Buller CE, Creager MA, Ettinger SM, Halperin JL, Hunt SA, Lytle BW, Nishimura R, Page RL, Riegel B, Tarkington LG, Yancy CW. 2007 focused update of the ACC/AHA 2004 guidelines for the management of patients with ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2008 Jan 15;51(2):210-47. doi: 10.1016/j.jacc.2007.10.001. No abstract available. Erratum In: J Am Coll Cardiol. 2008 Mar 4;51(9):977.
- Danchin N, Puymirat E, Aissaoui N, Adavane S, Durand E. [Epidemiology of acute coronary syndromes in France and in Europe]. Ann Cardiol Angeiol (Paris). 2010 Dec;59 Suppl 2:S37-41. doi: 10.1016/S0003-3928(10)70008-1. French.
- Task Force for Diagnosis and Treatment of Non-ST-Segment Elevation Acute Coronary Syndromes of European Society of Cardiology, Bassand JP, Hamm CW, Ardissino D, Boersma E, Budaj A, Fernandez-Aviles F, Fox KA, Hasdai D, Ohman EM, Wallentin L, Wijns W. Guidelines for the diagnosis and treatment of non-ST-segment elevation acute coronary syndromes. Eur Heart J. 2007 Jul;28(13):1598-660. doi: 10.1093/eurheartj/ehm161. Epub 2007 Jun 14. No abstract available.
- Charpentier S, Galinski M, Bounes V, Ricard-Hibon A, El-Khoury C, Elbaz M, Ageron FX, Manzo-Silberman S, Soulat L, Lapostolle F, Gerard A, Bregeaud D, Bongard V, Bonnefoy-Cudraz E; SCADOL II investigators. Nitrous oxide/oxygen plus acetaminophen versus morphine in ST elevation myocardial infarction: open-label, cluster-randomized, non-inferiority study. Scand J Trauma Resusc Emerg Med. 2020 May 12;28(1):36. doi: 10.1186/s13049-020-00731-y.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Disease
- Syndrome
- Acute Coronary Syndrome
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Analgesics, Non-Narcotic
- Antipyretics
- Analgesics, Opioid
- Narcotics
- Anesthetics, Combined
- Acetaminophen
- Morphine
- Entonox
Other Study ID Numbers
- RC31/13/7050
- 13705001 (Other Grant/Funding Number: French Ministry of Health, PHRC 2013)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Coronary Syndrome
-
Yonsei UniversityRecruitingCoronary Artery Disease, Acute Coronary SyndromeKorea, Republic of
-
Meditrix CorpNational University of Ireland, Galway, Ireland; Boston Scientific Japan K.K.; Fujita Health UniversityRecruitingChronic Coronary Syndrome | Non ST Segment Elevation Acute Coronary SyndromeJapan, Ireland
-
OrbusNeichDuke Clinical Research Institute; OrbusNeich Medical K.K.CompletedCoronary Arteriosclerosis | Non ST Segment Elevation Acute Coronary SyndromeUnited States, Japan
-
Medical University of WarsawRecruitingAcute Coronary Syndrome | Chronic Coronary Syndrome | Non ST Segment Elevation Acute Coronary SyndromePoland
-
Niguarda HospitalCompletedAcute Coronary Syndrome With ST Elevation on Electrocardiogram | Acute Coronary Syndrome Without ST Elevation on Electrocardiogram | Noncritical Coronary Artery Disease Coronary Stenosis Less Than 50 Per Cent | Aortic AneurysmsItaly
-
Sohag UniversityRecruitingLeft Main Coronary Artery Disease With Acute Coronary SyndromeEgypt
-
Eli Lilly and CompanyDaiichi Sankyo, Inc.CompletedCoronary Arteriosclerosis | Acute Coronary SyndromesUnited States
-
University of PatrasCompletedCoronary Artery Disease (CAD) | Acute Coronary Syndrome (ACS)Greece
-
The First Affiliated Hospital with Nanjing Medical...Unknown
-
Yonsei UniversityCompletedAcute Coronary Syndrome (ACS)Korea, Republic of
Clinical Trials on Morphine
-
Indiana UniversityCompletedNeonatal Abstinence Syndrome | Neonatal Opioid Withdrawal Syndrome | Neonatal Opioid WithdrawalUnited States
-
Javelin PharmaceuticalsCompleted
-
Javelin PharmaceuticalsCompletedPain, PostoperativeUnited States
-
University of MonastirCompletedTitrated Versus High and Low Dose Nebulized Morphine to Reduce Pain in Emergency Settings (TIMORNEB)Acute Pain | Post-Traumatic HeadacheTunisia
-
Mahidol UniversityCompletedLung Diseases | Solitary MassThailand
-
University of Colorado, DenverCompletedScoliosis | Pain Management | Spinal FusionUnited States
-
Javelin PharmaceuticalsCompletedPost-Operative Pain | Third Molar Extraction
-
Cukurova UniversityCompleted
-
University College Hospital GalwayCompletedPain, Postoperative | Arthroplasty, Replacement, Knee
-
Rijnstate HospitalCompletedTotal Hip Replacement