Dexmedetomidine Addition to Morphine in Patients With Metastatic Cancer

Metastatic Cancer Clinical Trial

Official title:

Does the Addition of Dexmedetomidine to Morphine Improve the Treatment of Pain in Patients With Metastatic Cancer? A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03936205
• Other study ID #: FM315
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 2016
• Est. completion date: October 2017

Study information

• Verified date: May 2019
• Source: Hotel Dieu de France Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis
• Neoplasms
• Neoplasms, Second Primary
• Pain, Intractable
• Refractory Pain

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hotel Dieu de France Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Morphine consumption		48 hours