A comparative study on differences in control methods for moderate or severe cancer pain

An Open-Label, Randomized, Parallel, Non-inferiority Phase ? trial to compare the efficacy and safety of controlling cancer pain between intravenous morphine infusion and oral long acting opioids

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0008879

Enrollment

Registered

2023-10-18

Start date

2025-02-03

Completion date

Unknown

Last updated

2025-05-26

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

Conditions

None listed

Interventions

Drug : i.v. morphine sulfate will be used. Morphine HCL will not be used due to the convulsive risk from the additive sodium bisulfite. total daily i.v. The mor-phine capacity is calculated using Tabl

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? A person diagnosed with cancer ? Uncontrolled cancer pain (in this study, those whose average pain intensity was 7/10 or higher on a numerical scale over the past 24 hours) ? Hematology oncology inpatient and outpatient ? Those who use oral morphine, oral oxycodone, oral oxycodone/naloxone (targin), or oral hydromorphone as background drugs ? Those who use strong opioids with a morphine equivalent daily dose of 30-300mg ? Those whose Karnofsky performance status was >= 50% before registration ? Age 19 or older at the time of registration ? Those with normal kidney and liver function

Exclusion criteria

Exclusion criteria: ? Those with delirium (i.e. Memorial delirium rating scale >13) ? Those with a history of substance use disorder within the past 12 months ? Those who are allergic to morphine ? Those who refuse to consent in advance ? Those who have pain only in certain positions ? Those who need opioid circulation due to toxicity ? Those who cannot take oral medication ? CAGE score >= 3 ? Minors/pregnant women, fetuses, newborns/adults with impaired consent/students, employees/prisoners, etc. in vulnerable environments

Design outcomes

Primary

Measure	Time frame
The difference in pain control between switching background opioid group (SG) and keeping background opioid group (KG) for two hours - pain control is defined as Numeric rating scale (NRS) = 3 or more points of pain reduction.	—

Secondary

Measure	Time frame
Side effects associated with the use of SC fentanyl (e.g., drowsiness, nausea, congestion) are evaluated using a numerical rating scale of 0-10. Satisfaction asks questions about the patient's pain. (Pain control satisfaction %)	—

Countries

Korea, Republic of

Contacts

Public ContactJung Hye Kwon

CHUNGNAM NATIONAL UNIVERSITY SEJONG HOSPITAL

kwonhye.onco@gmail.com+82-44-995-4781

Outcome results