Status:
COMPLETED
PCA vs Non-PCA Intravenous Hydromorphone Titration for Severe Cancer Pain
Lead Sponsor:
Fujian Cancer Hospital
Conditions:
Cancer Pain
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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 fo...
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. Con...
Eligibility Criteria
Inclusion
- With written informed consent signed voluntarily by patients themselves.
- Cancer patients aged 18-70 years old.
- Patients with cancer pain more than or equal to NRS 7 during previous 24 hours.
- Patients who will not be treated with radiotherapy within 7 days prior to randomization and during study.
- Patients who need chemotherapy, long term administration of hormone, targeted therapy, or bisphosphonates therapy should undergo a stable anti- tumor therapy prior to randomization.
- Patients or his/her caregivers who are able to fill out the questionnaire forms.
- Ability to correctly understand and cooperate with medication guidance of doctors and nurses.
- Without a history of anaphylaxis of narcotic drugs.
- Without psychiatric problems.
- ECOG performance status ≤3.
- Not participated in another drug clinical trial within one month before inclusion（including hydromorphone）.
Exclusion
- Patients diagnosed with non-cancer pain or unexplained pain.
- Patients suffered with post-op pain.
- Patients having paralytic ileus.
- Patients who have hypersensitivity to hydromorphone.
- There are abnormal lab results, with obvious clinical significance, such as the creatinine ≥ 2 fold of upper limit of normal value, or ALT or AST ≥ 2.5 fold of upper limit of normal value (≥ 5 fold,to the patients with liver metastasis or primary liver cancer), or liver function of Child C grade.
- Patients having a incoercible Nausea and vomiting.
- Monoamine oxidase inhibitor (MAOI) was administrated two week before randomization.
- Patients who are pregnant or lactating,who plans to be pregnant within one month after the trial（including male）.
- Patients who are opioid abuse.
- Patients who are alcohol abuse.
- Patients who are cognitive dysfunction.
- Patients having a severe psychotic depression.
- Patients with any other medical condition or reason, in that investigator's opinion, makes the patient unable to participate in a clinical trial.
Key Trial Info
Start Date :
September 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2020
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT03375515
Start Date
September 29 2018
End Date
January 10 2020
Last Update
March 8 2021
Active Locations (1)
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1
Rongbo Lin
Fuzhou, Fujian, China, 350014