Skip to content

ETUDE COMPARATIVE KETAMINE DOSE UNIQUE VERSUS KETAMINE BOLUS ET PERFUSION CONTINUE DANS LA PRISE EN CHARGE DE L’ANALGESIE DES DOULEURS TRAUMATIQUES DES MEMBRES EN MEDECINE D’URGENCE PREHOSPITALIERE - KETAPERF

ETUDE COMPARATIVE KETAMINE DOSE UNIQUE VERSUS KETAMINE BOLUS ET PERFUSION CONTINUE DANS LA PRISE EN CHARGE DE L’ANALGESIE DES DOULEURS TRAUMATIQUES DES MEMBRES EN MEDECINE D’URGENCE PREHOSPITALIERE - KETAPERF

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-004961-25-FR
Enrollment
Unknown
Registered
2008-10-21
Start date
2008-12-03
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Limbs peripheral traumatisms in prehospital emergency medicine

Interventions

Trade Name: Ketamine Product Name: Ketamine Pharmaceutical Form: Intravenous infusion INN or Proposed INN: ketamine chlorhydrate Concentration unit: mg/kg/h milligram(s)/kilogram/hour Concentration ty

Sponsors

CHRU de Lille
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Men and women aged 18-70 - Patients who must have a prehospital caring due to limbs peripheral traumatisms - Patients with a EVA score higher or equal to 6 - Patients with a social insurance Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients: - with several traumatisms - with consciousness troubles (Glasgow inferior or equal to 14) - with allergy to ketamine or morphine antecedent - with a contraindication to morphine or ketamine (know by caring): psychiatric antecedents, respiratory, renal, chronic hepatic, coronary insufficiency or heart failure, intracranial hypertension, thyrotoxicosis, eyeball wound, intraocular hypertension - chronic opioids use - pregnancy or menses delay - breast feeding women - who must undergo a loco-regional anesthesia - refusing the protocol or not capable of understanding or bearing (due to a heavy illness) its conditions, or of signing an informed consent - already enrolled in another study

Design outcomes

Primary

MeasureTime frame
Main Objective: The main objective is to assess the morphinic saving induced by the use of ketamine bolus followed by a continuous perfusion for limbs peripheral traumatisms victims in comparison with a single ketamine dose.;Secondary Objective: 1/To assess the appearance of side effects related to the use of morphine 2/To assess the tolerance of ketamine administered by continuous perfusion in this indication ;Primary end point(s): The primary end point is the diminution of 20% of morphine consumption at T60 or at the end of the caring step if its duration is inferior to one hour in the group treated with a continuous perfusion of ketamine

Countries

France

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026