Use of Analgesic Treatment to Reduce Signs of Pain in Patients With Disorders of Consciousness.
CompletedPhase 1NCT04330547
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Use of Analgesic Treatment to Reduce Signs of Pain in Patients With Disorders of Consciousness: a Double-blind Placebo-controlled Clinical Study.
- Conditions
- Disorders of Consciousness
- Severe Brain Injury
- Post-comatose Non-communicative Patients
- Vegetative State
- Minimally Conscious State
- Interventions
- Drug: Analgesic administration
- Drug: Placebo administration
- Sponsor
- University of Liege
- Start date
- 2018-02-21
- Primary completion
- 2019-02-19
- Sex
- All
- Age range
- from 16 Years to 99 Years
- Results posted
- No results posted in this snapshot
- Countries
- Belgium
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04330547