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Efficacy of butorphanol tartrate nasal spray in the management of breakthrough cancer pain.

Efficacy of butorphanol tartrate nasal spray in the management of breakthrough cancer pain.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100044620
Enrollment
Unknown
Registered
2021-03-24
Start date
2021-03-30
Completion date
Unknown
Last updated
2021-10-26

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

Conditions

Breakthrough pain of caner

Interventions

Butorphanol nasal spray group (Group B):Butorphanol tartrate nasal spray, 1 to 2 sprairies when breakthrough pain happens
Morphine injection group (M group):Morphine injection injection (when outbreak pain occurs)

Sponsors

Liaocheng People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Cancer patients aged 18-80 years. 2. Patients with cancer pain that is moderate to severe pain based on an NRS score of >3, as assessed by screening, who require titration of extended-release analgesic medication. 3. Patients presenting with outbreak pain with an NRS score >3 and requiring analgesic medication for relief. 4. 18 kg/m2 <= BMI <= 30 kg/m2; male and female are not limited. 5. Clearly understand and voluntarily participate in the study, and have their informed consent signed by themselves.

Exclusion criteria

Exclusion criteria: 1. Patients with contraindications in the instructions for Nojan's Butorphanol Tartrate Nasal Spray. 2. Patients with combined use of hormones, non-steroidal drugs, antidepressant and anticonvulsant drugs for analgesia. 3. Major organ failure, such as decompensated cardiac, pulmonary, hepatic and renal failure. 4. Consciousness impairment, cognitive dysfunction or combination of other psychiatric disorders. 5. Women during pregnancy or lactation. 6. Patients with elevated intracranial pressure and brain injury. 7. Patients with myocardial infarction, cardiac dysfunction, coronary artery insufficiency. 8. Patients with alcoholism, hypertension. 9. Paired with a drug clinical trial as a subject within the last 3 months. 10. Other conditions that the investigator considers inappropriate for participation in this trial. 11. Patients with oral or nasal mucosal injury (e.g. injury after radiotherapy for nasopharyngeal cancer).

Design outcomes

Primary

MeasureTime frame
pain score;

Secondary

MeasureTime frame
Survival quality score;Satisfaction evaluation;Remedial drug utilization;

Countries

China

Contacts

Public ContactLi Mingjun
li041204@163.com+86 13963573311

Outcome results

None listed

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