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Dexmedetomidine Addition to Morphine in Patients With Metastatic Cancer

Primary Purpose

Refractory Pain, Metastatic Cancer

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Dexmedetomidine

About this trial

This is an interventional health services research trial for Refractory Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Dexmedetomidine

Arm Description

Outcomes

Primary Outcome Measures

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

Morphine consumption

Secondary Outcome Measures

Full Information

NCT ID

NCT03936205

First Posted

May 1, 2019

Last Updated

May 11, 2019

Sponsor

Hotel Dieu de France Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03936205

Brief Title

Dexmedetomidine Addition to Morphine in Patients With Metastatic Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

August 2016 (Actual)

Primary Completion Date

October 2017 (Actual)

Study Completion Date

October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hotel Dieu de France Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Refractory Pain, Metastatic Cancer

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Title

Dexmedetomidine

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Dexmedetomidine

Intervention Description

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

Primary Outcome Measure Information:

Title

Pain score

Description

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

Time Frame

48 hours

Title

Morphine consumption

Time Frame

48 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

12. IPD Sharing Statement

Learn more about this trial

Dexmedetomidine Addition to Morphine in Patients With Metastatic Cancer

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