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

• Status: Completed
• Trial end date: 2021-04-28
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to characterize and improve pain and nociception management in patients with disorders of consciousness (DOC). This project is divided into two phases, a first phase to evaluate pain level and a second phase which consist of a clinical trial to evalute pain medication efficacy.

The main aim is to evaluate the use of the Nociception Coma Scale-Revised (NCS-R) and its cut-off score (i.e., 5) as an assessment and management tool to define guidelines for managing pain in patients with DOC. In this double-blind, placebo-controlled clinical study, we will evaluate the use of analgesic treatments in reducing pain in subacute/chronic patients. The project will also allow us to validate the NCS-R cut-off score defined previously.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Liege
• Treatments: Analgesics; Oxycodone

Criteria

Inclusion Criteria:

• Have had an acquired brain injury with a loss of consciousness > 28 days (patients) or have no history of previous brain injury (healthy controls)

• Legally authorized surrogate available to provide informed consent.

• Diagnosis of vegetative/unresponsive (VS/UWS) or minimally conscious state (MCS) or emergence of the minimally conscious state without communication (eMCS; as defined by the CRS-R, see above).

• Medically stable (i.e., no systemic illness or disease).

• Patients with NCS-R score during mobilization above or equal to the previously determined cut-off score or NCS-R scores during mobilization equivalent to NCS-R score obtain during nociceptive stimulation will be included in the second phase of the study (i.e. D1 and D2).

Exclusion Criteria:

• History of developmental, neurologic, or major psychiatric disorder resulting in functional disability.

• Contraindication or unwillingness to discontinuing sedating and centrally-active drugs (benzodiazepine, long-acting sedating drugs) within 48 hours of assessment.

• Upper limb contusions, fractures or flaccid paralysis.

• Uncontrolled epilepsy and already on level 1 drugs