NCT04330547

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

Use of Analgesic Treatment to Reduce Signs of Pain in Patients With Disorders of Consciousness: a Double-blind Placebo-controlled Clinical Study.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: University of Liege · Academic / Other
• Sex: All
• Age: 16 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Disorders of Consciousness
• Severe Brain Injury
• Post-comatose Non-communicative Patients
• Vegetative State
• Minimally Conscious State

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2018-02-21
• Primary completion: 2019-02-19
• Completion: 2021-04-28
• First posted: 2020-04-01
• Last updated: 2021-05-03

Locations

1 site across 1 country: Belgium