Dexmedetomidine Addition to Morphine in Patients With Metastatic Cancer

Phase 2

Completed

• Conditions: Refractory Pain; Metastatic Cancer
• Interventions: Drug: Dexmedetomidine

• Registration Number: NCT03936205
• Lead Sponsor: Hotel Dieu de France Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2019-05
• Study First Submitted: 2019-05-01
• Study First Submitted QC: 2019-05-01
• Study First Posted: 2019-05-03
• Last Update Submitted: 2019-05-11
• Last Update Posted: 2019-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine	Dexmedetomidine	-

Primary Outcome Measures

Name	Time	Method
Pain score	48 hours	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
Morphine consumption	48 hours