A randomized clinical trial of hydromorphone and fentanyl in continuous subcutaneous titration for severe cancer pain

JRCT ID: jRCT1051220045

Registered date:10/06/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Severe cancer pain
• Date of first enrollment: 10/06/2022
• Target sample size: 100
• Study type: Interventional
• Intervention(s): Continuous subcutaneous titration of opioids is performed. Methods: A 24 G plastic cannula is inserted subcutaneously in the abdomen; continuous subcutaneous administration is performed using a small syringe pump for 10 mL syringes. For pioid naive patients, opioids are infected by flow rates; (1) hydromorphone dissolved at 0.2 mg/mL, starting at 0.20 mL/h and increasing by 0.05 ml/h up to 1.0 ml/h. If the situation requires further increase of hydromorphone, replace with hydromorphone 1.0 mg/mL and restart at 0.2 ml/h. (2) Fentanyl is dissolved in 0.20 mg/mL and increased by 0.05 ml/h to 1.0 ml/h. The dose of fentanyl should be increased by 0.05 ml/h. For patients already receiving opioids, start with the equivalent opioid equivalent dose.

Outcome(s)

• Primary Outcome: At least 66% pain reduction of numerical ration scale within 3 days
• Secondary Outcome: Titration completion rate within 7 days; Titration completion days (days from start to end of continuous subcutaneous administration); Pain intensity at day 7 / Dyspnea / Sleep assessment / Quality of life assessment / Rescue medication use assessment / Adverse events.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients with severe cancer pain (numerial rating scale 7-10) who desired continuous subcutaneous titration with opioid analgesics.
• Exclude criteria: Impaired consciousness, delirium, cognitive impairment, renal impairment, hepatic impairment, poor general condition assessment, gastrointestinal transit disorder, patients under 20 years of age, drug allergy to the study drug, and patients who did not consent to participate in the study.

Related Information

• Primary Sponsor: Kajiyama Toru