IV PCA With or Without Continuous Dose vs Oral Opioid to Maintain Analgesia for Severe Cancer Pain After Successful Titration
- Conditions
- Cancer Pain
- Interventions
- Registration Number
- NCT04785768
- Lead Sponsor
- Fujian Cancer Hospital
- Brief Summary
Based on the previous HMORCT09-2, the results show that IV PCA for analgesia maintenance improvements control of severe cancer pain after successful titration. Therefore, a study is planned to further explore the difference of efficacy and safety between PCA with continuous + bolus dose versus bolus-only.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1372
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PCA with continuous + bolus dose Hydromorphone Hydrochloride Injection （1）Intravenous PCA with hydromorphone after successful titration of 24 hours;（2）PCA hydromorphone with continuous infusion where dose/h was the total equianalgesic over the previous 24h divided by 24 and bolus dosage for breakthrough pain was 10%-20% of the total equianalgesic over the previous 24h；lockout time = 10 minutes；（3）Evaluate every 24 hours and PCA parameters were adjusted according to the dose of the previous day; (4)The treatment regimen was continued for 7 days. PCA with bolus-only dose Hydromorphone Hydrochloride Injection （1）Intravenous PCA with hydromorphone after successful titration of 24 hours; (2)PCA hydromorphone with bolus-only where dosage was 10%-20% of the total equianalgesic over the previous 24h administrated as needed;（3）Evaluate every 24 hours and PCA parameters were adjusted according to the dose of the previous day; (4)The treatment regimen was continued for 7 days. Oral opioid Morphine Sulfate Sustained-release Tablets （1）Swift to sustained-release morphine orally as background dose with immediate release morphine orally for breakthrough pain after successful titration of 24 hours；(2)Oral sustained-released morphine where total equianalgesic over the previous 24h/2×75% every 12h/day and immediate-release morphine for breakthrough pain was 10%-20% of the total equianalgesic over the previous 24h； (3)Evaluate every 24 hours and the dose for the next day is adjusted according to the dose of the previous day；(4)The treatment regimen was continued for 7 days.
- Primary Outcome Measures
Name Time Method 3DNRS (3-day average Numeric Rating Scale) up to 4 days The Numerical Rating Scale (NRS, a score of 0 means no pain and 10 means the most severe) is used to assess the severity of pain. NRS of 24 hours is assessed every day. 3DNRS is a sum of average NRS of Day 1 (D 1) to Day 3 divided by 3 (the day of titration is defined as D0, the first day after titration is defined as D1, the second day after titration is defined as D2, and so on).
- Secondary Outcome Measures
Name Time Method Daily equivalent morphine consumption up to 7 days Daily equivalent morphine consumption
Maximum NRS (Days 1 to 6) up to 7 days Maximum NRS score (Days 1 to 6)
Adverse events up to 8 days assessed by NCI-CTCAE v5.0
Daily avNRS score of days 1 to 6 up to 7 days Daily average NRS pain score of days 1 to 6
Improvement in physical symptoms and overall well-being up to 7 days assessed by Chinese version of the Edmonton Symptom Assessment System.
Number of patients with an average NRS pain score >3 up to 7 days The Numerical Rating Scale (NRS, a score of 0 means no pain and 10 means the most severe) is used to assess the severity of pain.
Patient Satisfaction Score up to 7 days from 0 to 10, with 0 = extremely unsatisfied and 10 = extremely satisfied
Number of patients with an average NRS pain score > 6 up to 7 days The Numerical Rating Scale (NRS, a score of 0 means no pain and 10 means the most severe) is used to assess the severity of pain.
Daily frequency and duration of breakthrough cancer pain up to 7 days Daily frequency and duration of breakthrough cancer pain (defined as transient pain exacerbation \[NRS ≥4\])
Trial Locations
- Locations (1)
China, Fujian
🇨🇳Fuzhou, Fujian, China