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

NCT04330547 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2021-05-03

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • University of Liege

    lead OTHER

Principal Investigators

  • Steven Laureys, M.D., P.h.D · Centre du Cerveau, Coma Science Group (GIGA Consciousness)

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
16 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-21
Primary Completion
2019-02-19
Completion
2021-04-28

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04330547 on ClinicalTrials.gov