Use of Analgesic Treatment to Reduce Signs of Pain in Patients With Disorders of Consciousness.

PHASE1CompletedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

February 21, 2018

Primary Completion Date

February 19, 2019

Study Completion Date

April 28, 2021

Conditions
Disorders of ConsciousnessSevere Brain InjuryPost-comatose Non-communicative PatientsVegetative StateMinimally Conscious State
Interventions
DRUG

Analgesic administration

"* Level 1 : Paracétamol 1g/Acetaminophène 1g, Ibuprofène 600mg, Diclofénac 50mg.~* Level 2: Tramadol 50mg.~* Level 3: Oxycodone 5mg, Morphine sulfate 10mg.~* Increase of a prior level 3 medication :~ 1. 1/6 of the total dose of daily level 3 medication (e.g. the patient receives 30mg of oxycodone a day. He will be administered a single dose of 5 mg for the study), defined as a breakthrough dose in the management of chronic pain. To standardize the treatment, the dose of the prior level 3 medication will be converted to oxycodone. Several online tools exist to do the conversion between opioids (e.g. mobile app Orthodose ®).~ 2. If the oral intake or the gastrostomy use is not possible, the breakthrough dose will be administered by subcutaneous route. The dose will also be 1/6 of the daily dose and will be converted to injectable morphine. Conversion to injectable morphine will be performed with any equivalence tool (such as the mobile app Orthodose ®)"

DRUG

Placebo administration

Folavit (folic acid, 0.4 mg)

Trial Locations (1)

4000

Centre Hospitalier Universitaire de Liège, Liège

All Listed Sponsors
lead

University of Liege

OTHER

NCT04330547 - Use of Analgesic Treatment to Reduce Signs of Pain in Patients With Disorders of Consciousness. | Biotech Hunter | Biotech Hunter