A Phase 3 interventional study of inhaled titration of morphine chlorhydrate and IV placebo in Pain, Acute, Emergencies and Morphine, sponsored by University Hospital, Rouen. Completed at 20 sites in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-06.
Sponsored by University Hospital, Rouen · Phase 3, Interventional, and Treatment
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.
1,073 studies on the registry are indexed under Acute Pain; 166 are open to participants now.
This study's enrollment of 226 is above the median of 86 across 902 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →University Hospital, Rouen is the lead sponsor of 418 studies on the registry; 106 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
O of childbearing age: effective (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:
O Obstructive chronic obstructive or restrictive respiratory failure known or suspected compensated or not, O to the active substance or to any of the , 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
O Necessity to access the face O Allergy known to plastic
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Arm A: inhaled titration of morphine chlorhydrate+ IV placebo
Drug: inhaled titration of morphine chlorhydrate · Drug: IV placebo
Arm B:IV titration of morphine chlorhydrate + inhaled placebo
Device: Inhaled placebo · Drug: IV titration of morphine chlorhydrate
Patient in arm A will receive 1 to 3 titration
Also known as: IV placebo
Patient in arm A will receive 1 to 6 injection
Also known as: inhaled titration of morphine chlorhydrate
Patient in arm B will receive 1 to 3 titration
Also known as: IV titration of morphine chlorhydrate
Patient in arm BA will receive 1 to 6 injection
Also known as: Inhaled placebo
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).
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
Evaluate antalgic efficacy criteria
Quantity of morphine administered from the beginning of the titration until the end of the titration
Time frame: From the beginning of the titration until the end of the titration- assessed within one day
Evaluate antalgic efficacy criteria
Delay between first administration of Morphine and EVA ≤ 30 or EN ≤ 3 obtained
Time frame: From the beginning of the titration until the end of the titration- assessed up to one day
Evaluate antalgic efficacy criteria
Delay between first administration of Morphine and EVA ≤ 30 or EN ≤ 3 obtained for patient treated only with morphine IV
Time frame: From the beginning of the titration until the end of the titration- assessed up to one day
Evaluate antalgic efficacy criteria
Number of patients with EVA ≤ 30 or EN ≤ 3 at the end of titration
Time frame: From the beginning of the titration until the end of the titration- assessed up to one day
Evaluate antalgic efficacy criteria
Number of patients with EVA ≤ 30 or EN ≤ 3 at 30 minutes
Time frame: 30 minutes after the initiation of the titration
Evaluate antalgic efficacy criteria
Number of patients treated only by exclusive inhalation titration with EVA ≤ 30 or EN ≤ 3
Time frame: From the beginning of the titration until the end of the titration- assessed up to one day
Evaluate antalgic efficacy criteria
Quantity of of co-analgesia administered from the beginning of the titration
Time frame: From the beginning of the titration until the end of the titration- assessed up to one day
Evaluate antalgic efficacy criteria
Number of patients with EVA ≤ 30 or EN ≤ 3 after 60 minutes
Time frame: 1hour after the initiation of the titration
Evaluate antalgic efficacy criteria
Number of patients with EVA ≤ 30 or EN ≤ 3 after 120 minutes
Time frame: 2hours after the initiation of the titration
Assess the feasibility of an aerosol titration (compliance to the protocol)
Number of deviations from 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
Safety-Proportion of Sleepy patients (Ramsay score = 3) (adverse events)
Proportion of Sleepy patients (Ramsay score = 3)
Time frame: 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, ...)
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
Safety- Proportion of serious adverse events in each arm
Proportion of serious adverse events in each arm
Time frame: Until 3hours after the end of the titration
Plan to share: No
Ran from Sep 2017 to primary completion in Jul 2022, 58 months.
Of 25 non-industry phase 3 interventional studies under Acute Pain, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 27. This study's 58 months is above that.
Counting every sponsor, half of 53 studies reached it within 14 months; a quarter within 7 and three quarters within 25.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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