inhaled titration of morphine chlorhydrate
DrugPatient in arm A will receive 1 to 3 titration
Other names: IV placebo
NCT Number: NCT03257319
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.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 3
CH Agen-Nérac, Agen, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
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
O Necessity to access the face O Allergy known to plastic
Patient in arm A will receive 1 to 3 titration
Other names: IV placebo
Patient in arm A will receive 1 to 6 injection
Other names: inhaled titration of morphine chlorhydrate
Patient in arm B will receive 1 to 3 titration
Other names: IV titration of morphine chlorhydrate
Patient in arm BA will receive 1 to 6 injection
Other names: Inhaled placebo
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).
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
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
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
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
Time frame: 30 minutes after the initiation of the titration
Number of patients with EVA ≤ 30 or EN ≤ 3 at 30 minutes
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
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
Time frame: 1hour after the initiation of the titration
Number of patients with EVA ≤ 30 or EN ≤ 3 after 60 minutes
Time frame: 2hours after the initiation of the titration
Number of patients with EVA ≤ 30 or EN ≤ 3 after 120 minutes
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
Time frame: Until 3hours after the end of the titration
Proportion of Sleepy patients (Ramsay score = 3)
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,
...)
Time frame: Until 3hours after the end of the titration
Proportion of serious adverse events in each arm
University Hospital, Rouen
Other
Inhaled Versus Intravenous Opioid Dosing for the Initial Treatment of Severe Acute Pain in the Emergency Department
Acronym: CLIN-AEROMORPH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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