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Inhaled vs IV Opioid Dosing for the Initial Treatment of Severe Acute Pain in the Emergency Department (CLIN-AEROMORPH)

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ClinicalTrials.gov Identifier: NCT03257319
Recruitment Status : Unknown
Verified May 2018 by University Hospital, Rouen.
Recruitment status was:  Recruiting
First Posted : August 22, 2017
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

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 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.


Condition or disease Intervention/treatment Phase
Pain, Acute Emergencies Morphine Drug: inhaled titration of morphine chlorhydrate Drug: IV placebo Device: Inhaled placebo Drug: IV titration of morphine chlorhydrate Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 850 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Inhaled Versus Intravenous Opioid Dosing for the Initial Treatment of Severe Acute Pain in the Emergency Department
Actual Study Start Date : September 19, 2017
Estimated Primary Completion Date : September 19, 2019
Estimated Study Completion Date : September 19, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: inhaled morphine + IV placebo
Arm A: inhaled titration of morphine chlorhydrate+ IV placebo
Drug: inhaled titration of morphine chlorhydrate
Patient in arm A will receive 1 to 3 titration
Other Name: IV placebo

Drug: IV placebo
Patient in arm A will receive 1 to 6 injection
Other Name: inhaled titration of morphine chlorhydrate

Placebo Comparator: IV morphine +inhaled placebo
Arm B:IV titration of morphine chlorhydrate + inhaled placebo
Device: Inhaled placebo
Patient in arm B will receive 1 to 3 titration
Other Name: IV titration of morphine chlorhydrate

Drug: IV titration of morphine chlorhydrate
Patient in arm BA will receive 1 to 6 injection
Other Name: Inhaled placebo




Primary Outcome Measures :
  1. Rate of relief obtained or "success rate" at 1 hour from the start of drug administration, and not at the end of titration, such as EVA1 ≤ 30/100 (or EN1 ≤ 3/10). [ Time Frame: 1 hour after the initiation of the titration ]
    Rate of relief obtained or "success rate" at 1 hour from the start of drug administration, and not at the end of titration, such as EVA1 ≤ 30/100 (or EN1 ≤ 3/10).


Secondary Outcome Measures :
  1. Evaluate antalgic efficacy criteria [ Time Frame: From the beginning of the titration until the end of the titration- assessed within one day ]
    Quantity of morphine administered from the beginning of the titration until the end of the titration

  2. Evaluate antalgic efficacy criteria [ Time Frame: From the beginning of the titration until the end of the titration- assessed up to one day ]
    Delay between first administration of Morphine and EVA ≤ 30 or EN ≤ 3 obtained

  3. Evaluate antalgic efficacy criteria [ Time Frame: From the beginning of the titration until the end of the titration- assessed up to one day ]
    Delay between first administration of Morphine and EVA ≤ 30 or EN ≤ 3 obtained for patient treated only with morphine IV

  4. Evaluate antalgic efficacy criteria [ Time Frame: From the beginning of the titration until the end of the titration- assessed up to one day ]
    Number of patients with EVA ≤ 30 or EN ≤ 3 at the end of titration

  5. Evaluate antalgic efficacy criteria [ Time Frame: 30 minutes after the initiation of the titration ]
    Number of patients with EVA ≤ 30 or EN ≤ 3 at 30 minutes

  6. Evaluate antalgic efficacy criteria [ Time Frame: From the beginning of the titration until the end of the titration- assessed up to one day ]
    Number of patients treated only by exclusive inhalation titration with EVA ≤ 30 or EN ≤ 3

  7. Evaluate antalgic efficacy criteria [ Time Frame: From the beginning of the titration until the end of the titration- assessed up to one day ]
    Quantity of of co-analgesia administered from the beginning of the titration

  8. Evaluate antalgic efficacy criteria [ Time Frame: 1hour after the initiation of the titration ]
    Number of patients with EVA ≤ 30 or EN ≤ 3 after 60 minutes

  9. Evaluate antalgic efficacy criteria [ Time Frame: 2hours after the initiation of the titration ]
    Number of patients with EVA ≤ 30 or EN ≤ 3 after 120 minutes

  10. Assess the feasibility of an aerosol titration (compliance to the protocol) [ Time Frame: From the beginning of the titration until the end of the aerosol titration- within one hour after the start of the titration ]
    Number of deviations from protocol

  11. Safety-Proportion of Sleepy patients (Ramsay score = 3) (adverse events) [ Time Frame: Until 3hours after the end of the titration ]
    Proportion of Sleepy patients (Ramsay score = 3)

  12. Safety- incidence of minor side effects in each arm of which neurovegetative usually known and related to opiates (nausea, vomiting, urine retention, ...) [ Time Frame: Until 3hours after the end of the titration ]

    incidence of minor side effects in each arm of which neurovegetative usually known and related to opiates (nausea, vomiting, urine retention,

    ...)


  13. Safety- Proportion of serious adverse events in each arm [ Time Frame: Until 3hours after the end of the titration ]
    Proportion of serious adverse events in each arm



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Exclusion Criteria:

  • 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03257319


Locations
Show Show 19 study locations
Sponsors and Collaborators
University Hospital, Rouen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT03257319    
Other Study ID Numbers: 2014/009/HP
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Emergencies
Acute Pain
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents