Pain is one of the most common and fear symptoms for cancer patients, which seriously affects the quality of life in cancer patients. At present, oral opioid is the most common route to administrate cancer pain. However, the patients do not satisfy the pain administration with oral opioid after successful titration in many cases, especially the cases with severe cancer pain. Patient controlled analgesia (PCA) with hydromorphone can take analgesic effect rapidly. The aim of this trial is to compare the maintenance with hydromorphone PCA intravenously or switch to Sustained-Release Morphine orally after successful titraton with hydromorphone PCA intravenously in severe cancer pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
95
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 once every 24 hours
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 once every 24 hours
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 d1; the total equianalgesic of the previous 24 hours/2 for day 2 and day 3; 2) Immediate release morphine orally = 10-20% of the total equianalgesic of the previous 24 hours; 3) Evaluate once every 24 hours
China, Fujian
Fuzhou, Fujian, China
Mean pain score
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. The mean pain score is a sum of NRS of day 1 (the day after successful titration of 24 hours) to day 3 divided by 3. If the NRS of the morphine orally group \>3, the NRS in the hydromorphone PCA intravenously group declines more than 30% compared to morphine orally group, which is regards a positive result.
Time frame: From day1 to day3
Number of Breakthrough cancer Pain (BTcP) episodes
If NRS of the morphine orally group pain score ≤3 , or if NRS in the hydromorphone PCA intravenously group declines less than 30% compared to morphine orally group, number of Breakthrough cancer Pain (BTcP) episodes in the one of both the hydromorphone PCA intravenously group declines less than 30% compared to morphine orally group, which is regards a positive result.
Time frame: From day1 to day3
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: From day1 to day3
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.
Time frame: From day1 to day3
Total dosage of opioids
The total dosage of opioids in day 1 to day 3 (day 1 is the day after successful titration of 24 hours)
Time frame: 3 days
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: 3 days
Quality of life of patients
Chinese version of the Edmonton Symptom Assessment System.
Time frame: At 24 hours
Number of patients who switched/discontinued therapy due to serious adverse events or lack of pain control
The number of patients who switched/discontinued therapy due to serious adverse events or lack of pain control
Time frame: 3 days
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