Morphine Titration with Intravenous Patient-Controlled Analgesia for Severe Cancer Pai

Not Applicable

Recruiting

• Conditions: Symptoms, signs and abnormal clinical and laboratory findings, NEC

• Registration Number: KCT0006890
• Lead Sponsor: Dong-A University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 January 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

1. Male or female over the age of 19 who provided written consent
2. If you have had cancer pain with an average NRS score of 7 or higher within the past 24 hours
3. Subjects who can accurately understand the pain intensity NRS and follow the drug use guide
4. A person who understands the purpose of this clinical trial and the procedures necessary for the clinical trial, and is able to sign and submit the informed consent form including the requirements and regulations listed in the consent form and this clinical trial protocol

Exclusion Criteria

1. If there is a history of side effects such as decreased breathing with opioid analgesics
2. If you are taking a morphine equivalent daily dose (MEDD) of 300 mg/day or more
3. If the analgesic effect was not shown by previous administration or administration of morphine
4. Subjects with cognitive impairment or serious mental illness that will interfere with the progress of the study
5. Subjects who are pregnant, lactating, and planning to become pregnant within 1 month of participation in the study (including men)
6. Creatinine > 2 x upper limit of normal
7. Patients with severe respiratory depression
? Patients with acute and severe asthma and hypercapnia
? Patients with severe chronic obstructive airway disease
? Patients with severe chronic obstructive pulmonary disease and pulmonary heart disease
? If it is included in the following criteria in the lung function test
1. FEV1 / FVC < 70% or
2. FEV1 < 30% or
3. FEV1 <50% with chronic respiratory failure
8. Patients receiving MAO inhibitors at the time of screening or within 14 days of discontinuation of treatment
9. Patients with liver and biliary tract disease; Patients with moderate to severe hepatic impairment
? ALT or AST >3.0 x ULN
? Total bilirubin >1.5 x ULN
10. When the Investigator determines that other measures of pain control may be affected.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean pain numeric rating scale (NRS) 1 hour after initiation of PCA

Secondary Outcome Measures

Name	Time	Method
Rate of pain NRS =3 after 1 hour;Mean pain NRS after 2 hours, 4 hours, 24 hours, and 48 hours;Number of breakthrough pains in 24 hours;Quality of life survey through brief pain inventory;Total opioid consumption dosage used for titration(24, 48hrs);adverse events;Patient Global Impression of Change (PGI-C) evaluated by subjects