IV PCA With or Without Continuous Dose vs Oral Opioid to Maintain Analgesia for Severe Cancer Pain After Successful Titration

• Status: Not yet recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fujian Cancer Hospital
• Treatments: Hydromorphone; Morphine

Criteria

Inclusion Criteria:

1. The patients were 18-80 years old and diagnosed as malignant solid tumor by pathology;

2. Patients with persistent cancer pain and NRS score ≥ 7 during previous 24 hours;

3. Patients who did not receive radiotherapy, chemotherapy or targeted therapy within 7 days before randomization and trial；

4. Patients or his/her caregivers who are able to fill out the questionnaire forms ;

5. Ability to correctly understand and cooperate with medication guidance of doctors and nurses ;

6. Without psychiatric problems;

7. ECOG performance status ≤3;

8. Patients who did not receive the trial drug within 14 days before the trial；

9. The subjects voluntarily signed the informed consent.

Exclusion Criteria:

1. The pain is confirmed not due to cancer;

2. Patients with severe post-operative pain;

3. Patients with paralytic ileus;

4. Patients with brain metastasis;

5. Patients hypersensitive to opioids;

6. Patients with abnormal lab results that have obvious clinical significance, such as creatine ≥ 2 fold of upper limit of normal value, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 fold of upper limit of normal value, or liver function of Child C grade;

7. Patients who cannot take drugs orally;

8. Patients with an incoercible nausea or vomiting;

9. Those who have received monoamine oxidase inhibitor (MAOI) within two weeks before randomization;

10. Patients who are pregnant or in lactation, or who plan to be pregnant within one month after the trial;

11. Alcoholic patients;

12. Patients with other conditions or reasons causing the patients unable to complete the clinical trial.