Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 20, 2017
First Posted Date  ICMJE August 22, 2017
Last Update Posted Date May 30, 2018
Actual Study Start Date  ICMJE September 19, 2017
Estimated Primary Completion Date September 19, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2017)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2017)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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)
  • 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, ...)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Inhaled vs IV Opioid Dosing for the Initial Treatment of Severe Acute Pain in the Emergency Department
Official Title  ICMJE Inhaled Versus Intravenous Opioid Dosing for the Initial Treatment of Severe Acute Pain in the Emergency Department
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Pain, Acute
  • Emergencies
  • Morphine
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: inhaled morphine + IV placebo
    Arm A: inhaled titration of morphine chlorhydrate+ IV placebo
    Interventions:
    • Drug: inhaled titration of morphine chlorhydrate
    • Drug: IV placebo
  • Placebo Comparator: IV morphine +inhaled placebo
    Arm B:IV titration of morphine chlorhydrate + inhaled placebo
    Interventions:
    • Device: Inhaled placebo
    • Drug: IV titration of morphine chlorhydrate
Publications * Lvovschi VE, Joly J, Lemaire N, Maignan M, Canavaggio P, Leroi AM, Tavolacci MP, Joly LM. 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. Trials. 2019 Apr 11;20(1):209. doi: 10.1186/s13063-019-3326-3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 21, 2017)
850
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 19, 2019
Estimated Primary Completion Date September 19, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03257319
Other Study ID Numbers  ICMJE 2014/009/HP
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Rouen
Study Sponsor  ICMJE University Hospital, Rouen
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital, Rouen
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP