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Table 1 Inclusion and exclusion criteria

From: Nebulized versus intravenous morphine titration for the initial treatment of severe acute pain in the emergency department: study protocol for a multicenter, prospective randomized and controlled trial, CLIN-AEROMORPH

Inclusion criteria

 • Age ≥ 18 and < 75 years

 • VAS ≥ 70/100 or NRS ≥ 7/10

 • Patient affiliated with or beneficiary of a social security category

 • For women (childbearing age)

  ○ Effective contraception (oral contraception, intrauterine device or use of condoms)

  ○ Menopausal status (amenorrhea less than 12 months before the inclusion visit)

  ○ Objectivized sterility (diagnosis or surgically)

Exclusion criteria

 • Chronic pain (> 3 months)

 • Taking opioids more than 10 days (including opioids as tramadol and/or codeine)

 • Taking opioids in the emergency room within 4 h

 • Taking rifampicin

 • Impaired ability to discern, cognitive impairment

 • Morphine-related contraindications

  ○ Chronic obstructive or restrictive respiratory failure known or suspected, compensated or not

  ○ Hypersensitivity to the active substance or to any of the excipients

  ○ Severe hepatocellular insufficiency (known or suspected)

  ○ Chronic renal failure known or suspected

  ○ Acute renal failure (creatinine clearance < 60 ml/min/1.73 m2 and/or increase of 25% from baseline)

  ○ Uncontrolled epilepsy

  ○ Cranial trauma (intracranial hypertension)

  ○ Associations with buprenorphine, nalbuphine, pentazocine, or naltrexone

 • Active drug history or practice(s)

 • Obvious need to reduce fracture or dislocation in the emergency room

 • Suspected occlusive syndrome

 • SpO2 < 95%

 • Respiratory rate (RR) < 12 breaths/min

 • Glasgow Coma Scale (GCS) < 15 or other alertness disorders

 • Heart rate (HR) < 50 bpm and/or auriculo-ventricular block (PR interval > 200 ms)

 • Arterial hypotension with systolic blood pressure TA syst < 100 mmHg

 • Pregnancy or lactation

 • Persons deprived of their liberty by an administrative or judicial decision, persons placed under the safeguard of justice, guardianship

 • Patients with poor comprehension of spoken or written French

 • Patients participating in another interventional clinical study

 • Contraindication related to the use of saline solution

 • Contraindications related to the use of aerosol:

  ○ Necessity to access the face

  ○ Allergy known to plastic

  ○ Claustrophobia