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 @ 3:14 AM
Ignite Modification Date:
2025-12-25 @ 3:14 AM
NCT ID:
NCT04296305
Eligibility Criteria:
Inclusion Criteria:
* Hospitalized patients with diagnosis of cancer
* History of moderate to severe cancer related pain, defined as Numerical Rating Scale (NRS) pain score \>= 4/10
* Receiving no or only on as needed doses of opioids
* Normal cognitive status, defined as a normal state of arousal and an absence of obvious clinical findings of confusion, memory deficits or concentration deficits or a Memorial Delirium Assessment Scale (MDAS) score of \< 13
* Ability to read and communicate in the English language
* Written informed consent from patient
Exclusion Criteria:
* Contraindications to opioids, or history of opioid allergy
* Inability to secure IV access
* Known history or evidence of nonmedical opioid use (e.g. abuse, misuse, addiction)
* Oxygen saturations \< 92% or respiratory rate \< 12 breaths/minute on initial assessment
* Resting heart rate \> 120 on initial assessment
* Systolic blood pressure \> 180 \< 90 mmHg or diastolic pressure \> 100 \< 60 mmHg on initial assessment
* Patients receiving scheduled chronic opioid therapy (defined as the treatment of pain with opioids for \>= 7 days)
* Moderate to severe renal insufficiency (defined as glomerular filtration rate \[GFR\] \< 60 ml/min/1.73 m\^2)
* Hepatic insufficiency (defined as alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] \> 3 times the highest normal value, or total bilirubin \> 1.5 times the highest normal value)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04296305
Study Brief:
Protocol Section:
NCT04296305