Comparison of MEOPA + Paracetamol Versus Morphine Treatment in Acute Coronary Syndrome Analgesia. (SCADOLII)
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.
Acute Coronary Syndrome
Drug: MEOPA and paracetamol
|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.|
- 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.
- 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
|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)|
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 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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02198378
|Contact: Sandrine Charpentier, PH, MD||05 67 69 16 76 ext email@example.com|
|Contact: Vanessa. Houzé-Cerfon., CRA||0567691676 ext firstname.lastname@example.org|
|Principal Investigator:||Sandrine Charpentier, PH,MD||CHU Toulouse|