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A multicenter, randomized, parallel, controlled clinical study of patient controlled intravenous analgesia with hydromorphone hydrochloride injection and morphine hydrochloride injection for moderate to severe cancer

A multicenter, randomized, parallel, controlled clinical study of patient controlled intravenous analgesia with hydromorphone hydrochloride injection and morphine hydrochloride injection for moderate to severe cancer

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900028015
Enrollment
Unknown
Registered
2019-12-08
Start date
2019-12-09
Completion date
Unknown
Last updated
2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cancer pain

Interventions

Group A :PCA intravenous infusion with hydromorphone
Group B:PCA intravenous infusion with morphine

Sponsors

Fuling Central Hospital of Chongqing City
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Subjects fully understand and voluntarily sign informed consent; (2) Aged 18 years or above, no gender restriction; (3) Cancer pain patients with NRS score >= 4, with an estimated survival time of more than 1 month; (4) Can objectively describe symptoms without severe infection or respiratory insufficiency; (5) No severe blood coagulation dysfunction; patients without severe liver and kidney dysfunction: generally no more than 2 times the upper limit of normal value. Patients with liver cancer (including metastatic liver cancer), bile duct cancer, and pancreatic cancer can be relaxed to 5 times the normal upper limit; (6) Patients without a history of drug abuse; (7) Non-pregnant and lactating women; subjects (including male subjects) who did not have a pregnancy plan within 1 month after the end of the trial; (8) did not participate in the drug test (including the test drug) within 3 months before the test.

Exclusion criteria

Exclusion criteria: (1) Radiotherapy should be performed within 4 weeks before the trial, and anti-tumor treatment such as chemotherapy or molecular targeted therapy should be performed during the trial; (2) sponsors or researchers directly participating in the trial or their family members; (3) Patients with respiratory depression but lack of CPR devices or monitoring facilities, or have shown cyanosis, increased intracranial pressure and craniocerebral injury; bronchial asthma; decompensated pulmonary heart disease; hypothyroidism; cortical function Incompleteness; benign prostatic hyperplasia, dysuria; severe hepatorenal dysfunction; shock before correction; presence or risk of progression to gastrointestinal obstruction, especially in patients with paralytic intestinal obstruction. (4) Those who are allergic to hydromorphone, hydromorphone salt, morphine and other ingredients in medicines; (5) The researcher believes that there is no reason to be selected; (6) People with brain metastases or mental symptoms; (7) Researchers judge that cancer pain can be solved by emergency surgery (such as intestinal obstruction, pathological fracture).

Design outcomes

Primary

MeasureTime frame
Pain assessment;Anxiety score;Depression score;

Secondary

MeasureTime frame
Disturbance of pain to daily life;Daily pain relief rate;Patient satisfaction with analgesic treatment;Patient compliance with analgesic treatment;

Countries

China

Contacts

Public ContactZhou Qi

Department of Oncology, Fuling Central Hospital of Chongqing City

anneengun@gmail.com+86 18996706515

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026