Effect of Opioid Infusion Rate on Abuse Liability Potential of Intravenous Hydromorphone for Cancer Pain

• Status: Recruiting
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: All

Summary

In cancer inpatient settings, intravenous (IV) opioids are frequently administered in a bolus fashion in order to obtain immediate pain relief. However, data on the abuse liability (AL) potential of IV opioids in cancer patients is limited. No study has investigated the effect of different IV infusion rates on AL potential in patients receiving parenteral opioids for pain control. This phase IV trial will determine the AL potential of a slow IV hydromorphone (SH) bolus administration compared with a fast IV hydromorphone (FH) bolus administration among inpatients with cancer pain. It will also determine the analgesic efficacy and adverse effect profiles of SH versus FH bolus infusions, and explore the relationship between pharmacogenetics and pharmacokinetic (PK) and pharmacodynamic (PD) effects of hydromorphone. This study will eventually help develop evidence-based guidelines regarding the best style of IV opioid administration which will achieve the most optimal pain control while avoiding the undesirable complication of nonmedical opioid use

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Hydromorphone

Criteria

Inclusion Criteria:

• Hospitalized patients with diagnosis of cancer

• Moderate to severe cancer related pain, defined as Numerical Rating Scale (NRS) pain score >= 4/10 at the time of study intervention

• 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)