NCT03375515

PCA vs Non-PCA Intravenous Hydromorphone Titration for Severe Cancer Pain

Patient Controlled Analgesia (PCA) vs Non-PCA Intravenous Hydromorphone Titration for Severe Cancer Pain: A Prospective, Randomized, Controlled, Multi-center, Phase III Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 214 (actual)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cancer Pain

Interventions

Type	Name	Description
DRUG	Hydromorphone	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.
DEVICE	PCA pump	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.

Timeline

• Start date: 2018-09-29
• Primary completion: 2019-12-10
• Completion: 2020-01-10
• First posted: 2017-12-18
• Last updated: 2021-03-08

Locations

1 site across 1 country: China