Comparison of MEOPA + Paracetamol Versus Morphine Treatment in Acute Coronary Syndrome Analgesia. (SCADOLII)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by University Hospital, Toulouse
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT02198378
First received: July 22, 2014
Last updated: NA
Last verified: July 2014
History: No changes posted
  Purpose

In the management of acute coronary syndromes with ST-segment elevation (STEMI), early analgesia reduces the effects of hyperadrenergism which increases the size of myocardial infarction. In order to reduce pain intensity, the recommendations advocate emergency use of morphine. In STEMI patients, other analgesic treatments could provide analgesia that is at least as effective as morphine. The equimolar oxygen/nitrous oxide mixture (mélange équimolaire oxygène protoxyde d'azote, or MEOPA) is widely used in emergency medicine and has minor secondary effects that are very rapidly reversible when inhalation is discontinued. Used in association with paracetamol, it could be an at least equally effective alternative to the use of morphine.


Condition Intervention Phase
Acute Coronary Syndrome
Drug: MEOPA and paracetamol
Drug: Morphine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • Effective analgesia (NRS score≤ 3) at 30 minutes after the start of analgesia [ Time Frame: 30 minutes after randomisation. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Adverse event [ Time Frame: all 5 minutes during 30 minutes ] [ Designated as safety issue: Yes ]
    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.

  • NRS distribution [ Time Frame: 30 minutes after randomization ] [ Designated as safety issue: No ]
    Distribution of the NRS at 30 minutes and on arrival at the cardiology unit

  • Effective anagesia [ Time Frame: all 5 minutes during 30 minutes ] [ Designated as safety issue: No ]
    The time of effective analgesia will be defined for each subject


Estimated Enrollment: 684
Study Start Date: November 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Morphine
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 Name: Morphine Renaudin 10mg/ml
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.

Drug: MEOPA and paracetamol
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 Name: Entonox 135 bar

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with STEMI < 12 h treated before hospital admission and pain ≥ 4 on the numerical rating scale.

Exclusion Criteria:

  • Age < 18 years
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02198378

Contacts
Contact: Sandrine Charpentier, PH, MD 05 67 69 16 76 ext 33 charpentier.s@chu-toulouse.fr
Contact: Vanessa. Houzé-Cerfon., CRA 0567691676 ext 33 houze-cerfon.v@chu-toulouse.fr

Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Sandrine Charpentier, PH,MD CHU Toulouse
  More Information

Publications:
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. Review. No abstract available. Erratum in: J Am Coll Cardiol. 2008 Mar 4;51(9):977.

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02198378     History of Changes
Other Study ID Numbers: 13705001, 13705001
Study First Received: July 22, 2014
Last Updated: July 22, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Toulouse:
premixed nitrous oxide and oxygen
pain
prehospital setting
acute coronary syndrome

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Morphine
Acetaminophen
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Antipyretics

ClinicalTrials.gov processed this record on September 18, 2014