Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT03936205
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03936205
Study Brief:
Protocol Section:
NCT03936205