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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,372
Intravenous PCA with hydromorphone after successful titration of 24 hours.the PCA setting: 1) continuous dose (dose/hours) = the total dosage of hydromorphone in the previous 24 hours/24; 2) bolus dose = 10-20% of the total dosage of hydromorphone in the previous 24 hours; 3) lockout time = 10 minutes; 4)Evaluate every 24 hours and PCA parameters were adjusted according to the dose of the previous day.
Intravenous PCA with hydromorphone after successful titration of 24 hours.the PCA setting: 1) continuous dose = 0; 2) bolus dose = 10-20% of the total dosage of hydromorphone in the previous 24 hours: 3) lockout time = 10 minutes; 4)Evaluate every 24 hours and PCA parameters were adjusted according to the dose of the previous day.
China, Fujian
Fuzhou, Fujian, China
3DNRS (3-day average Numeric Rating Scale)
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).
Time frame: up to 4 days
Daily avNRS score of days 1 to 6
Daily average NRS pain score of days 1 to 6
Time frame: up to 7 days
Adverse events
assessed by NCI-CTCAE v5.0
Time frame: up to 8 days
Improvement in physical symptoms and overall well-being
assessed by Chinese version of the Edmonton Symptom Assessment System.
Time frame: up to 7 days
Patient Satisfaction Score
The satisfaction score of the patients to analgesia was evaluated by 10-point scale: 0 points for dissatisfaction, 10 points for very satisfied, the higher the score, the higher the satisfaction.
Time frame: up to 7 days
Daily equivalent morphine consumption
Daily equivalent morphine consumption
Time frame: up to 7 days
Number of patients with an average NRS pain score > 6
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Swift to sustained-release morphine orally as background dose with immediate release morphine orally for breakthrough pain after successful titration of 24 hours. Administration of morphine orally 1) Sustained-release morphine orally (dose/12 hours) = the total equianalgesic of the previous 24 hours/2×75% for day 1; 2)the total equianalgesic of the previous 24 hours/2 for day 2 ; 3)Evaluate every 24 hours and the dose for the next day is adjusted according to the dose of the previous day;4) Immediate release morphine orally = 10-20% of the total equianalgesic of the previous 24 hours;
Time frame: up to 7 days
Number of patients with an average NRS pain score >3
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.
Time frame: up to 7 days
Patient Satisfaction Score
from 0 to 10, with 0 = extremely unsatisfied and 10 = extremely satisfied
Time frame: up to 7 days
Maximum NRS (Days 1 to 6)
Maximum NRS score (Days 1 to 6)
Time frame: up to 7 days
Daily frequency and duration of breakthrough cancer pain
Daily frequency and duration of breakthrough cancer pain (defined as transient pain exacerbation \[NRS ≥4\])
Time frame: up to 7 days