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

May 25, 2018 updated by: University Hospital, Rouen

Inhaled Versus Intravenous Opioid Dosing for the Initial Treatment of Severe Acute Pain in the Emergency Department

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

850

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Agen, France
      • Aulnay-sous-Bois, France
      • Bordeaux, France
      • Caen, France
        • Recruiting
        • CHU de Caen
        • Contact:
      • Clermont-Ferrand, France
      • Grenoble, France
      • Le Havre, France
        • Recruiting
        • GH Le Havre
        • Contact:
      • Le Mans, France
      • Lille, France
      • Lyon, France
      • Nice, France
      • Paris, France
      • Paris, France
        • Recruiting
        • Hopital Lariboisiere
        • Contact:
      • Paris, France
      • Rouen, France, 76031
      • Saint-Ouen, France
      • Strasbourg, France
      • Toulouse, France
      • Évreux, France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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 Names:
  • IV placebo
Drug: IV placebo
Patient in arm A will receive 1 to 6 injection
Other Names:
  • 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 Names:
  • IV titration of morphine chlorhydrate
Drug: IV titration of morphine chlorhydrate
Patient in arm BA will receive 1 to 6 injection
Other Names:
  • Inhaled placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
1 hour after the initiation of the titration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From the beginning of the titration until the end of the titration- assessed within one day
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
From the beginning of the titration until the end of the titration- assessed up to one day
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
From the beginning of the titration until the end of the titration- assessed up to one day
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
From the beginning of the titration until the end of the titration- assessed up to one day
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
30 minutes after the initiation 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
Number of patients treated only by exclusive inhalation titration with EVA ≤ 30 or EN ≤ 3
From the beginning of the titration until the end of the titration- assessed up to one day
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
From the beginning of the titration until the end of the titration- assessed up to one day
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
1hour after the initiation of the titration
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
2hours after the initiation of the titration
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
From the beginning of the titration until the end of the aerosol titration- within one hour after the start of the titration
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)
Until 3hours after the end of the titration
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,

...)
Until 3hours after the end of the titration
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
Until 3hours after the end of the titration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 19, 2017

Primary Completion (ANTICIPATED)

September 19, 2019

Study Completion (ANTICIPATED)

September 19, 2019

Study Registration Dates

First Submitted

July 20, 2017

First Submitted That Met QC Criteria

August 21, 2017

First Posted (ACTUAL)

August 22, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 30, 2018

Last Update Submitted That Met QC Criteria

May 25, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/009/HP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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