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Hydromorphone

simple hydromorphone PCA pump model, which is a rapid titration followed by a convenient maintenance technique, to treat home cancer patients with severe or critical cancer pain or refractory cancer pain.

PCA pump

This prospective observational study will evaluate the efficacy and adverse effects of a "simple hydromorphone PCA pump model", which is a rapid titration followed by a convenient maintenance technique, to treat home cancer patients with severe or critical cancer pain or refractory cancer pain.

This is a single-arm multicenter study that will involve 8-10 centers and 50 cases in total. A better pumping mode was discovered through repeated optimization and adjustment of PCA pump parameters, ensuring the unity of convenience, safety, and flexibility: on the one hand, it is convenient for clinicians to set up and adjust the pump quickly; on the other hand, it is also convenient for patients to control at home; thus, it solves the complex pumping and dosing problems. Nearly 20 patients with severe cancer pain or a cancer pain crisis were treated using this model, and the control satisfaction rate was 100% in each case.

The purpose of this study is to:

1. Main objective: To explore the efficacy and adverse effects of a simple hydromorphone PCA pump model, i.e., rapid titration followed by maintenance, for the treatment of patients with severe cancer pain or cancer pain crisis or refractory cancer pain in home cancer patients.
2. Exploratory purpose: To screen sensitive indicators for cancer pain assessment and efficacy monitoring by Ella fully automated microfluidic ELISA system, and to explore the mechanism of action of pain-causing substances in cancer pain initially.

Home Management of Simple Hydromorphone PCA Pump Mode

A Single-arm Multicenter Study on the Home Management of Simple Hydromorphone PCA Pump Mode in Cancer Patients Suffering Severe or Critically Painful

Subjects self-assess on the NRS pain rating scale in the subject log sheet, where subjects assess the level of cancer pain experienced in the past 24 hours.

Paroxysmal pain is defined as a sudden and transient pain exacerbation that occurs spontaneously or triggered by some predictable or unpredictable factors under the premise of relatively stable background pain control and adequate application of analgesic drugs. The onset, duration and number of cancer eruption pain episodes were recorded by the subjects in the logbook at the time of the episode.

The WHOQOL-BREF is a 26-item self-assessment questionnaire that investigates the last two weeks of physical health, mental health, social relationships, and environment. It allows for a reliable, valid and brief assessment of quality of life. In this study, the psychological domain (6 items) was used to represent the psychological aspects of quality of life.

During the trial, monitoring the number of occurrences of PCA blockage and reflux in patients, as well as will record the number of times they seek help from healthcare professionals in case of PCA pump-related problems that cannot be solved by themselves.

the content of PD 1, IL-2, IL-6, STING, CD3+, CD4+, IFN-1and IFN-γ in patients' serum

The First Affiliated Hospital of Xinxiang Medical College

Analgesics, Opioid

Narcotics

PCA titration using programmable pump: bolus hydromorphone at 0.5mg (for opioid intolerance) or hydromorphone dose equivalent to 10% to 20% of the total opioid taken in the previous 24 hours with a lockout time 15 min (for opioid tolerance) was administered by the patients educated. No basal infusion was set in the pump.Repeated assessment of NRS score with a interval of 15 minutes until stable pain control. Then Repeated assessment of NRS score with a interval of 1 hour. The titration will be done on the patient's request (manipulation by the patient himelf/herself) in 24hrs.

Non-PCA titration administered by a nurse or clinician: Initial hydromorphone doses were same with PCA titration. Repeated assessment of NRS score with a interval of 15 minutes until stable pain control. Then Repeated assessment of NRS score with a interval of 1 hour. The dose of hydromorphone increased by 50%-100% if pain unchanged or increased, or repeat same dose if pain decrease to 4-6. The titration will be done on the patient's request (manipulation by a nurse) in 24hrs.

1. For opioid-intolerant patients: continuous infusion of hydromorphone 0 mg per hour, and a demand dose of 0.5 mg with a lockout interval of 15 minutes.
2. For opioid-tolerant patients: basal rate 0 mg per hour, and a demand dose of 10% of the hydromorphone dose equivalent to the total opioid taken in the previous 24 hrs with a lockout interval of 15 minutes.

1. For opioid-intolerant patients: initial dose 0.5 mg intravenous hydromorphone.
2. For opioid-tolerant patients: intravenous hydromorphone with a initial dose equivalent to 10%(5-15%) of the total opioid taken in the previous 24 hrs.

Rongbo Lin

A large number of studies have shown that patients feel more satisfied with hydromorphone in the pain management. and a systematic review found that hydromorphone may be better suited than morphine for titration of acute analgesia. However, current researches on intravenous opioid titration for cancer pain such as hydromorphone are relatively insufficient in China. Therefore, a prospective, multi-center, randomized controlled study is conducted to assess the efficacy and safety of comparing patient-controlled analgesia (PCA) versus non-PCA intravenous hydromorphone titration for severe cancer pain.

The opioid dose for individual with cancer pain to provide adequate relief of pain with an acceptable degree of side effects is variable. Opioid titration is a process to obtain the tailored dose. Conventional titration is administered by a clinician or nurse. PCA is that patients control cancer pain by self-administration of intravenous opioids using programmable pump. The aim of our study is to evaluate the efficacy of PCA titration versus conventional titration intravenously for severe cancer pain (10-point numerical rating scale, NRS ≥ 7). Injectable Hydromorphone was selected as pharmaceutical analgesics, which works as well as morphine and oxycodone and had similar side effects.

PCA vs Non-PCA Intravenous Hydromorphone Titration for Severe Cancer Pain

Patient Controlled Analgesia (PCA) vs Non-PCA Intravenous Hydromorphone Titration for Severe Cancer Pain: A Prospective, Randomized, Controlled, Multi-center, Phase III Trial

The satisfied pain control was defined NRS pain score ≤ 3 at rest in at least 2 consecutive assessment (15 minutes interval). The time needed to successful titration was extended to achieve satisfied pain control again if NRS pain score ≥ 7 after satisfied pain control within 24 hours. The failure of successful titration was defined that satisfied pain control does not achieve within 24 hours.

The percentage of patients who titrated successfully within 60 minutes

The percentage of patients who titrated successfully within 24 hours

The Numerical Rating Scale (NRS) is used to assess the severity of pain. The scale represents pain levels in 0-10 numbers, with 0 indicating no pain and 10 indicating the most severe pain. Ask the patient to choose the number that best represents his or her pain level, or ask the patient to ask: How severe is participant's pain? The health care provider selects the appropriate number based on the patient's description of the pain. 1-3 points indicate mild pain, 4-6 points indicate moderate pain, and 7-10 points indicate severe pain. "The mean NRS pain score of 24 hrs" is defined as the sum of the scores within 24 hours divided by the number of evaluations within 24 hours.

The total dose of hydromorphone titrated from start of titration to TST

The total dose of hydromorphone titrated within 24 hrs

The change from baseline in questionnaire: Chinese version of the Edmonton Symptom Assessment System

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Home Management of Simple Hydromorphone PCA Pump Mode	NCT05744089	Cancer Pain Tumor, Solid Carcinoma	PCA pump	18 Years -	The First Affiliated Hospital of Xinxiang Medical College
PCA vs Non-PCA Intravenous Hydromorphone Titration for Severe Cancer Pain	NCT03375515	Cancer Pain	Hydromorphone PCA pump	18 Years - 70 Years	Fujian Cancer Hospital
Home Management of Simple Hydromorphone PCA Pump Mode	NCT05744089	Cancer Pain Tumor, Solid Carcinoma	PCA pump	18 Years -	The First Affiliated Hospital of Xinxiang Medical College

Spots Global Cancer Trial Database for pca pump

Every month we try and update this database with for pca pump cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pca pump

Every month we try and update this database with for pca pump cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pca pump cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.