drugset / Trial / NCT04330547

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

NCT04330547

Phase 1 Completed 19 enrolled University of Liege
RandomizedCrossoverQuadruple-blindSupportive care

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetaminophen Small molecule 1 g Oral
Comparator Diclofenac Other / unclassified 50 mg Oral
Comparator Ibuprofen Small molecule 600 mg Oral
Comparator Morphine Other / unclassified 10 mg Oral
Comparator Oxycodone Other / unclassified 5 mg Oral
Comparator Tramadol Other / unclassified 50 mg Oral