A large number of studies have shown that patients feel more satisfied with hydromorphone in the pain management. and a systematic review found that hydromorphone may be better suited than morphine for titration of acute analgesia. However, current researches on intravenous opioid titration for cancer pain such as hydromorphone are relatively insufficient in China. Therefore, a prospective, multi-center, randomized controlled study is conducted to assess the efficacy and safety of comparing patient-controlled analgesia (PCA) versus non-PCA intravenous hydromorphone titration for severe cancer pain.
The opioid dose for individual with cancer pain to provide adequate relief of pain with an acceptable degree of side effects is variable. Opioid titration is a process to obtain the tailored dose. Conventional titration is administered by a clinician or nurse. PCA is that patients control cancer pain by self-administration of intravenous opioids using programmable pump. The aim of our study is to evaluate the efficacy of PCA titration versus conventional titration intravenously for severe cancer pain (10-point numerical rating scale, NRS ≥ 7). Injectable Hydromorphone was selected as pharmaceutical analgesics, which works as well as morphine and oxycodone and had similar side effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
214
1. For opioid-intolerant patients: continuous infusion of hydromorphone 0 mg per hour, and a demand dose of 0.5 mg with a lockout interval of 15 minutes. 2. For opioid-tolerant patients: basal rate 0 mg per hour, and a demand dose of 10% of the hydromorphone dose equivalent to the total opioid taken in the previous 24 hrs with a lockout interval of 15 minutes.
1. For opioid-intolerant patients: initial dose 0.5 mg intravenous hydromorphone. 2. For opioid-tolerant patients: intravenous hydromorphone with a initial dose equivalent to 10%(5-15%) of the total opioid taken in the previous 24 hrs.
Rongbo Lin
Fuzhou, Fujian, China
The time of successful titration in 24 hours
The satisfied pain control was defined NRS pain score ≤ 3 at rest in at least 2 consecutive assessment (15 minutes interval). The time needed to successful titration was extended to achieve satisfied pain control again if NRS pain score ≥ 7 after satisfied pain control within 24 hours. The failure of successful titration was defined that satisfied pain control does not achieve within 24 hours.
Time frame: In 24 hours
The percentage of patients titrated successfully within 60 minutes
The percentage of patients who titrated successfully within 60 minutes
Time frame: Up to 60 minutes
The percentage of patients titrated successfully within 24 hours
The percentage of patients who titrated successfully within 24 hours
Time frame: Up to 24 hours
The mean NRS pain score of 24 hours
The Numerical Rating Scale (NRS) is used to assess the severity of pain. The scale represents pain levels in 0-10 numbers, with 0 indicating no pain and 10 indicating the most severe pain. Ask the patient to choose the number that best represents his or her pain level, or ask the patient to ask: How severe is participant's pain? The health care provider selects the appropriate number based on the patient's description of the pain. 1-3 points indicate mild pain, 4-6 points indicate moderate pain, and 7-10 points indicate severe pain. "The mean NRS pain score of 24 hrs" is defined as the sum of the scores within 24 hours divided by the number of evaluations within 24 hours.
Time frame: Up to 24 hours
The total dose of hydromorphone titrated from start of titration to TST
The total dose of hydromorphone titrated from start of titration to TST
Time frame: Up to 24 hours
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The total dose of hydromorphone titrated within 24 hrs
The total dose of hydromorphone titrated within 24 hrs
Time frame: Up to 24 hours
Improvement of patient symptoms
The change from baseline in questionnaire: Chinese version of the Edmonton Symptom Assessment System
Time frame: Up to 24 hours
Adverse Events
treatment-related Adverse Events:
Time frame: Up to 7 days