Use of Analgesic Treatment to Reduce Signs of Pain in Patients With Disorders of Consciousness: a Double-blind Placebo-controlled Clinical Study.
Overview
- Phase
- Phase 1
- Intervention
- Analgesic administration
- Conditions
- Disorders of Consciousness
- Sponsor
- University of Liege
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Coma Recovery Scale-Revised (CRS-R)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief 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.
Detailed Description
The study will be performed within one week (i.e, 7 days) and consists of two phases: * Phase 1 "Patients selection (D0)": Patients will be assessed by the NCS-R during experimental stimulation (rest, tactile, noxious) and mobilizations (physiotherapy). Patients with potential pain will be included in the phase 2. * Phase 2 "Analgesic administration (D1 and D2)": double-blind placebo-controlled randomized clinical trial on potential responders identified in phase 1. A medical doctor of our team will suggest to the physician in charge to prescribe the dedicated medication. One placebo and one real treatment will be administered on day 1 and 2 by the nurses at least half-hour before the physiotherapy. Randomization between day 1 and 2 will be applied at that time. For each day of phase 1 and 2, several assessments will be performed: NCS-R, CRS-R and spasticity assessment.
Investigators
Aurore Thibaut
PhD
University of Liege
Eligibility 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
Arms & Interventions
Analgesic administration
The analgesic treatment will be tailored to the patient's medication and will be based on 3 levels (based on Ventafridda et al., 1985): * Level 1 : Non-opioid analgesics * Level 2 : Weak opioids analgesics * Level 3 : Strong opioids analgesics If the patient is already on pain medications, we will add the lowest effective dose of the level above the level of the regular pain medications of the patient. (e.g. if the patient has no analgesic treatment, he will be given a non-opioid analgesic (level 1). If he already has a level 1 treatment, we will go for level 2 medication. If he has level 2 treatment, we will go for level 3. And if the patient is already at level 3, we will increase the dosage by steps (reference: 5mg oxycodone as first choice for level 3 drugs)). Preferably, the medication will be administered by oral intake or gastrostomy feeding tube. If it is not possible, other routes of administration are allowed.
Intervention: Analgesic administration
Placebo administration
Folavit capsules will be used as a placebo
Intervention: Placebo administration
Outcomes
Primary Outcomes
Coma Recovery Scale-Revised (CRS-R)
Time Frame: through study completion, an average of 2 years
The CRS-R (Giacino et al., 2004) is the gold standard for the behavioural assessment of the level of consciousness and is widely used in patients with chronic disorders of consciousness. The CRS-R is composed of six subscales that assess the following domains: visual, motor, auditory and oro-motor/verbal functions, as well as communication, and arousal. The score ranges from 0 to 23, in which the lowest score indicates coma and the highest score indicates the emergence from the minimally conscious state. The diagnosis is made according to the presence\\absence of particular behavioural responses.
Nociception Coma Scale-Revised (NCS-R)
Time Frame: through study completion, an average of 2 years
The NCS-R (Chatelle et al., 2012) is used to assess the perception of acute pain in patients with disorders of consciousness. It is composed of 3 subscales (motor, verbal and facial expressions) respectively scoring from 0 (no response) to 3 (highest response level). Here the NCS-R is administered in 4 different conditions: at rest, during tactile stimulation, during experimental nociceptive stimulation (pressure on the bed of the left and right nail) and during mobilization (physiotherapy).
Secondary Outcomes
- Modified Ashworth Scale (MAS)(through study completion, an average of 2 years)