Informations générales (source: ClinicalTrials.gov)
Inhaled Versus Intravenous Opioid Dosing for the Initial Treatment of Severe Acute Pain in the Emergency Department (CLIN-AEROMORPH)
Interventional
Phase 3
University Hospital, Rouen (Voir sur ClinicalTrials)
septembre 2017
septembre 2019
29 juin 2024
Prospective single-blind, multicenter, national, randomized, controlled trial in 15
Emergency Department to compare two ways of morphine titration. The eligible patient is
included immediately after his arrival in the Emergency Department, after being
questioned by the triage nurse about the presence and the intensity of pain, when the VAS
is greater than 70 (or EN>7) and after written consent.
After installation into the examination room, patient is randomized in one of two
parallel groups (stratified by sex and center using software) and receives one of the two
treatments, either inhaled morphine + IV placebo or IV morphine+ inhaled placebo (control
group).
In both groups, titration is defined by a dose of repeated boluses as long as the relief
is not achieved (VAS> 30 or EN >3) and the criteria to stop titration are not met.
A 5 minutes time interval between the boluses is chosen. Each aerosol takes 5 minutes at
a constant air flow, aerosol mask, plastic tubing and PVC transparent tank are used.
Thus patient receives a maximum of 3 aerosol (one aerosol every 10 minutes) and a maximum
of 6 IV injections (one injection every 5 minutes) The stopping criteria, except pain
relief, are linked to the occurrence of side effects and specific cares are described
into the protocol (in case of severe ventilatory depression naloxone titration is
provided). Exit criteria from the emergency room and from the hospital are defined. An
information sheet is delivered.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Cochin | F LECOMTE | Contact (sur clinicalTrials) | |||
| C.H. ROBERT BALLANGER | Anna BOUCHARA | Contact (sur clinicalTrials) | |||
| IFSI-IFAS DU CH BICHAT-CLAUDE BERNARD | A-E CASALINO | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CH Agen-Nérac - Agen - France | P-A FORT | Contact (sur clinicalTrials) | |||
| CH Eure Seine Hôpital d'Evreux - Évreux - France | Arnaud Depil-duva | Contact (sur clinicalTrials) | |||
| CHU de Caen - Caen - France | C LE ROUX | Contact (sur clinicalTrials) | |||
| Chu Strasbourg - Strasbourg - France | S kepka | Contact (sur clinicalTrials) | |||
| Hospices civils de Lyon - Lyon - France | karim tazarourte | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CH Le Mans - Le Mans - France | O MOULIN | Contact (sur clinicalTrials) | |||
| CHRU de Lille - Lille - France | eric wiel | Contact (sur clinicalTrials) | |||
| chu de Toulouse - Toulouse - France | S charpentier | Contact (sur clinicalTrials) | |||
| CHU Gabriel Montpied - Clermont-Ferrand - France | J. RACONNAT | Contact (sur clinicalTrials) | |||
| CHU Grenoble - Grenoble - France | M MAIGNAN | Contact (sur clinicalTrials) | |||
| CHU Hôpitaux BORDEAUX - Bordeaux - France | M GALINSKI | Contact (sur clinicalTrials) | |||
| CHU Nice - Nice - France | J LEVRAUT | Contact (sur clinicalTrials) | |||
| CHU-Hôpitaux de Rouen - 76031 - Rouen - France | Lionel DA CRUZ | Contact (sur clinicalTrials) | |||
| GH Le Havre - Le Havre - France | XAVIER BENET | Contact (sur clinicalTrials) | |||
| Hôpital Lariboisière - Paris - France | N Ouled-Jaballah | Contact (sur clinicalTrials) | |||
| La Pitié Salpétrière - Paris - France | pierre Hausfater | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Age ≥ 18 and <75 years old;
- EVA ≥ 70/100 or EN ≥ 7/10;
- Patient who received clear information from the investigator and read and signed the
consent form;
- Patient affiliated with, or beneficiary of a social security category;
- For women:
O of childbearing age: effective contraception (oral contraception, intrauterine device
or use of condoms) O menopausal status (amenorrhoea less than 12 months before the
inclusion visit) O objectivized sterility (diagnosis or surgically)
- Age ≥ 18 and <75 years old;
- EVA ≥ 70/100 or EN ≥ 7/10;
- Patient who received clear information from the investigator and read and signed the
consent form;
- Patient affiliated with, or beneficiary of a social security category;
- For women:
O of childbearing age: effective contraception (oral contraception, intrauterine device
or use of condoms) O menopausal status (amenorrhoea less than 12 months before the
inclusion visit) O objectivized sterility (diagnosis or surgically)
- Chronic pain (> 3 months)
- Taking opioids longer than 10 days (including "weak" opioids tramadol and / or
codeine);
- Taking Rifampicin;
- Impaired ability to discern, cognitive impairment;
- Morphine-related contraindications:
O Obstructive chronic obstructive or restrictive respiratory failure known or suspected
compensated or not, O Hypersensitivity to the active substance or to any of the
excipients, O Severe hepatocellular insufficiency (known or suspected), O Chronic renal
failure known or suspected, O Uncontrolled epilepsy, O Cranial trauma (intracranial
hypertension), O Associations with buprenorphine, nalbuphine, pentazocine and naltrexone
- Active drug history or practice (s);
- Evidence of reduced fracture or dislocation in emergency rooms;
- Suspected occlusive syndrome
- SaO2 <95%;
- FR <12 / min;
- Glasgow <15 or other alertness disorders;
- HR heart rate <50 bpm and / or Auriculo-Ventricular block (PR XML File Identifier:
zR6XOYKSEQ9GjQHghP8c465EwF0= Page 15/30 interval> 200 ms);
- Arterial hypotension with systolic blood pressure TA syst <100 mm Hg;
- Pregnant or nursing
- Persons deprived of their liberty by an administrative or judicial decision, a
person placed under the safeguard of justice, guardianship;
- Patients with poor comprehension of spoken or written French;
- Patients participating in another interventional clinical study;
- Contra-indication related to the use of saline solution
- Contra-indications related to the use of aerosol:
O Necessity to access the face O Allergy known to plastic