IV PCA With or Without Continuous Dose vs Oral Opioid to Maintain Analgesia for Severe Cancer Pain After Successful Titration

PHASE3CompletedINTERVENTIONAL
Enrollment

1,372

Participants

Timeline

Start Date

July 1, 2021

Primary Completion Date

May 1, 2024

Study Completion Date

July 1, 2024

Conditions
Cancer Pain
Interventions
DRUG

Hydromorphone Hydrochloride Injection

Intravenous PCA with hydromorphone after successful titration of 24 hours.the PCA setting: 1) continuous dose (dose/hours) = the total dosage of hydromorphone in the previous 24 hours/24; 2) bolus dose = 10-20% of the total dosage of hydromorphone in the previous 24 hours; 3) lockout time = 10 minutes; 4)Evaluate every 24 hours and PCA parameters were adjusted according to the dose of the previous day.

DRUG

Hydromorphone Hydrochloride Injection

Intravenous PCA with hydromorphone after successful titration of 24 hours.the PCA setting: 1) continuous dose = 0; 2) bolus dose = 10-20% of the total dosage of hydromorphone in the previous 24 hours: 3) lockout time = 10 minutes; 4)Evaluate every 24 hours and PCA parameters were adjusted according to the dose of the previous day.

DRUG

Morphine Sulfate Sustained-release Tablets

"Swift to sustained-release morphine orally as background dose with immediate release morphine orally for breakthrough pain after successful titration of 24 hours.~Administration of morphine orally 1) Sustained-release morphine orally (dose/12 hours) = the total equianalgesic of the previous 24 hours/2×75% for day 1; 2)the total equianalgesic of the previous 24 hours/2 for day 2 ; 3)Evaluate every 24 hours and the dose for the next day is adjusted according to the dose of the previous day;4) Immediate release morphine orally = 10-20% of the total equianalgesic of the previous 24 hours;"

Trial Locations (1)

350014

China, Fujian, Fuzhou

All Listed Sponsors
lead

Fujian Cancer Hospital

OTHER_GOV