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出境医 / 临床实验 / Dexmedetomidine Addition to Morphine in Patients With Metastatic Cancer

Dexmedetomidine Addition to Morphine in Patients With Metastatic Cancer

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.


Condition or disease Intervention/treatment Phase
Refractory Pain Metastatic Cancer Drug: Dexmedetomidine Phase 2 Phase 3

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Does the Addition of Dexmedetomidine to Morphine Improve the Treatment of Pain in Patients With Metastatic Cancer? A Pilot Study
Actual Study Start Date : August 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017
Arms and Interventions
Arm Intervention/treatment
No Intervention: Control
Experimental: Dexmedetomidine Drug: Dexmedetomidine
Patients allocated to this group receive a combination of Morphine and Dexmedetomidine
Outcome Measures
Primary Outcome Measures :
  1. Pain score [ Time Frame: 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

  2. Morphine consumption [ Time Frame: 48 hours ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

No Contacts or Locations Provided

Tracking Information
First Submitted Date  ICMJE May 1, 2019
First Posted Date  ICMJE May 3, 2019
Last Update Posted Date May 14, 2019
Actual Study Start Date  ICMJE August 2016
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2019)
  • Pain score [ Time Frame: 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 [ Time Frame: 48 hours ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 1, 2019)
  • Pain score [ Time Frame: First 48 hours post intervention initiation ]
  • Morphine consumption [ Time Frame: First 48 hours post intervention initiation ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dexmedetomidine Addition to Morphine in Patients With Metastatic Cancer
Official Title  ICMJE Does the Addition of Dexmedetomidine to Morphine Improve the Treatment of Pain in Patients With Metastatic Cancer? A Pilot Study
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Refractory Pain
  • Metastatic Cancer
Intervention  ICMJE Drug: Dexmedetomidine
Patients allocated to this group receive a combination of Morphine and Dexmedetomidine
Study Arms  ICMJE
  • No Intervention: Control
  • Experimental: Dexmedetomidine
    Intervention: Drug: Dexmedetomidine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 1, 2019) 		18
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2017
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03936205
Other Study ID Numbers  ICMJE FM315
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nicole Naccache, Hotel Dieu de France Hospital
Study Sponsor  ICMJE Hotel Dieu de France Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hotel Dieu de France Hospital
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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