Status:
UNKNOWN
Inhaled vs IV Opioid Dosing for the Initial Treatment of Severe Acute Pain in the Emergency Department
Lead Sponsor:
University Hospital, Rouen
Conditions:
Pain, Acute
Emergencies
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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 h...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
September 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 19 2019
Estimated Enrollment :
850 Patients enrolled
Trial Details
Trial ID
NCT03257319
Start Date
September 19 2017
End Date
September 19 2019
Last Update
May 30 2018
Active Locations (19)
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1
CH Agen-Nérac
Agen, France
2
CHI Robert Ballanger
Aulnay-sous-Bois, France
3
CHU Hôpitaux BORDEAUX
Bordeaux, France
4
CHU de Caen
Caen, France