Dexmedetomidine Addition to Morphine in Patients With Metastatic Cancer

Hotel Dieu de France Hospital

Status and phase

Completed

Phase 3

Phase 2

Conditions

Metastatic Cancer

Refractory Pain

Treatments

Drug: Dexmedetomidine

Study type

Interventional

Funder types

Other

Identifiers

NCT03936205

FM315

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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
Patient providing his explicit consent to participate in the study before inclusion (regardless of his inclusion in C or D Group)
Patients with systolic blood pressure (SBP) ≥ 100 mmHg and a diastolic blood pressure (DBP) ≥ 50 mmHg
Patients with a heart rate ≥ 50/min

Exclusion criteria

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.