Patient controlled analgesia (PCA) versus non-PCA intravenous hydromorphone titration for severe cancer pain: A randomized, controlled, multicenter, phase III trial, HMORCT09-1.

TPS11635 Background: The opioid dose for an 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. Methods: This is currently enrolling patients (n=230) with severe cancer pain during previous 24 hours. Patients are randomized 1:1 and stratified by opioid intolerance or opioid tolerance into PCA or non-PCA titration. PCA titration using programmable pump: bolus hydromorphone at 0.5mg (for opioid intolerance) or hydromorphone dose equivalent to 10% to 20% of the total opioid taken in the previous 24 hours with a lockout time 15 minutes (for opioid tolerance) was administered by the patients educated. No basal infusion was set in the pump. Non-PCA titration administered by a nurse or clinician: Initial hydromorphone doses were same with PCA titration. Reassess pain at 15 minutes. Increased dose of hydromorphone by 50%-100% if pain unchanged or increased, or repeat same dose if pain decreased to NRS 4-6, or continue at current effective dose as needed over initial 24 hours. The primary endpoint is the time needed to successful titration was defined the time from the first dose of hydromorphone after randomization to achieve satisfied pain control. 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. Secondary endpoints include the percentage of patients titrated successfully, the mean NRS pain score of 24 hours, the total dose of hydromorphone titrated, and adverse events. Clinical trial information: NCT03375515.