Dexmedetomidine Addition to Morphine in Patients With Metastatic Cancer

NCT03936205 | Completed Phase 2

• 1 other identifier: FM315
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

Pain is a common symptom in patients nearing the end of life. Its prevalence varies between 30 and 75%. Nowadays, morphine is the most used molecule as first line treatment of moderate to severe pain. However, this molecule, considering its side effects, may contribute in part to the discomfort of these patients and may increase the pre-existing agitation or delirium. There is therefore a need to find new agents, other than morphine, for pain control at the end of life, without the limitations that the morphine molecule has. The author reviewed the literature on the role of dexmedetomidine in the treatment of refractory symptoms in palliative care, including pain. It is an agonist of the adrenergic alpha 2 receptor having a sedative, analgesic action and a morphine sparing effect demonstrated postoperatively. This study aims primarily at demonstrating that dexmedetomidine has a beneficial role in the treatment of pain in patients with metastatic cancer.

Conditions

Refractory Pain; Metastatic Cancer

Outcome Measures

Primary Outcomes (2)

• Pain score

  The visual analogue score is used to asses for pain score, the scale varies between 0 and 10 where 0 is no pain and 10 is worst pain encountered

  48 hours

• Morphine consumption

  48 hours

Study Arms (2)

Control

NO INTERVENTION

Dexmedetomidine

EXPERIMENTAL

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

Patients allocated to this group receive a combination of Morphine and Dexmedetomidine

Dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any painful patient with metastatic cancer
• Whatever type of pain: nociceptive, neuropathic, or mixed
• Age \> 18 and \<75 years
• Patient under analgesic Tier III treatment: with moderate to severe pain and not relieved by non-opioid conventional treatment
• Patient cooperating capable of responding to the pain assessment by providing a number from 0 to 10 at the VAS
• Patients with systolic blood pressure (SBP) ≥ 100 mmHg and a diastolic blood pressure (DBP) ≥ 50 mmHg
• Patients with a heart rate ≥ 50/min

You may not qualify if:

• Patient refusal to participate in the study or patient unable to give consent
• Age \<18 or \> 75 years
• Comatose uncooperative patient unable to respond to the assessment of pain by VAS
• Hypotensive patients with SBP \< 100 mmHg and DBP \< 60 mmHg or bradycardic with a heart rate \< 50/min
• Patient with a heart rhythm disorder, or a disorder of the atrial-ventricular conduction
• Patients under beta-blocker
• Patient with heart failure with an ejection fraction \< 40%
• Patient suffering from allergy or previous intolerance to morphine or dexmedetomidine
• Patient with renal impairment with a creatinine clearance \<3 0ml/min/1.73m2, or patient under hemodialysis or peritoneal dialysis.
• Patient with severe hepatic impairment with Child-Pugh score at C.

Sponsors & Collaborators

• Hotel Dieu de France Hospital: lead

MeSH Terms

Conditions

Pain, Intractable; Neoplasm Metastasis

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplastic Processes; Neoplasms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: May 1, 2019
• First Posted: May 3, 2019
• Study Start: August 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: May 14, 2019

Record last verified: 2019-05