Hydromorphone intravenous controlled analgesia with five elements music therapy for moderate to severe cancer pain:A Randomized Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300076805

Enrollment

Unknown

Registered

2023-10-18

Start date

2023-11-01

Completion date

Unknown

Last updated

2023-10-22

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

Conditions

Cancer Pain

Interventions

A Group:hydromorphone PCIA with five elements music therapy

B Group:hydromorphone intravenous controlled analgesia

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Subjects voluntarily participate in the study, with good compliance, are able to cooperate with the experimental observation, and sign written informed consent. 2) Age 18-80 years old, regardless of gender; 3) Patients with malignant tumors confirmed by imaging and/or pathology; 4) Persistent cancer pain with NRS (0-10 points) =4 points or explosive pain times > 3 times/day; 5) Patients who have not received radiotherapy within 7 days prior to randomization and trial; 6) The patient has no severe cognitive impairment or mental illness; 7) ECOG-PS score =3;

Exclusion criteria

Exclusion criteria: 1) The patient was diagnosed with non-cancer pain or pain of unknown cause; 2) Postoperative pain; 3) Paralytic ileus patients; 4) Allergic to opioids; 5) Abnormal and clinically significant laboratory results, such as creatinine = 2 times the upper limit of normal, ALT or AST= 2.5 times the upper limit of normal (= 5 times the upper limit of normal in patients with liver metastases or primary liver cancer), or liver function Child grade C; 6) Uncontrollable nausea and vomiting; 7) Use of monoamine oxidase inhibitors within 14 days before randomization; 8) Participated in other drug trials within 30 days prior to enrollment; 9) Diseases and conditions that are not considered to be eligible by other investigators.

Design outcomes

Primary

Measure	Time frame
Clinical success rate, defined as the rate of =50% pain relief in patients.;	—

Secondary

Measure	Time frame
Daily dosage of test drug;Number of breakthrough pain;Patient's daily NRS score;Patient satisfaction with pain control;appraisal of life quality;	—

Countries

China

Contacts

Public ContactLikun Liu

Shanxi Academy of Traditional Chinese Medicine

Llkun133@126.com+86 136 2360 9166

Outcome results

None listed

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