Nervous System Diseases

Symptoms and General Pathology

All Conditions

Rare Diseases

Neuralgia

Pain

Nociceptive Pain

Peripheral Nervous System Diseases

Neuromuscular Diseases

Neurologic Manifestations

Chronic Graft Versus Host Disease

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Adjuvants, Anesthesia

Oxycodone

Morphine

Analgesics, Opioid

Oxymorphone

Narcotics

Anesthetics

Oxymorphone ER

Marco Pappagallo

Marco Pappagallo, MD

This project will explore the safety and feasibility of performing a successful intravenous patient controlled analgesia (IV PCA) Oxymorphone titration and conversion to oral ER Oxymorphone (extended release or OPANA ER) in the outpatient setting.

This project will enroll 12 volunteers who suffer from chronic pain. Potential participants must be on one of the following therapies:

* Long acting morphine
* Oxycodone Participants will be asked to complete a pain diary for approximately 10 days and to stop taking their current pain medications the night before they are admitted o the GCRC. Once the patients present at the GCRC, they will be started on the IV PCA (Patient Controlled Analgesia) Oxymorphone to control their pain. Titration will take approximately a total of 8 hrs. At the end of the titration period, patients will be discharged home on OPANA ER. The oral dose will be calculated based on the IV PCA use. During the titration, patients' pain, vital and side effects will be assessed hourly until the 8th hour of the IV PCA titration.

Patients will be contacted daily by a member of the study team to assess pain and side effects. The OPANA ER dose will be adjusted as needed to adequately manage both.

If patients do not feel as though they are getting adequate pain relief, they can return to their previous medication, at which point they are considered withdrawn from the study.

Patients will undergo an exit examination 2 weeks after they were admitted to the GCRC in order to assess pain relief. In addition, a final follow-up telephone interview will take place 6 weeks after the initial 1-day stay at the GCRC. Our research staff or physicians will ask about your pain treatment and ask which Opioid medication you are currently taking.

A Pilot Study of Ultra Rapid Opioid Rotation and Titration of Oxymorphone

Endo Pharmaceuticals

Icahn School of Medicine at Mount Sinai

Marco Pappagallo, MD, Director of Pain Research and Development

Cancer Pain

Hydromorphone

1. Intravenous PCA with hydromorphone after successful titration of 24 hours.
2. 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 once every 24 hours

1. Intravenous PCA with hydromorphone after successful titration of 24 hours.
2. 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 once every 24 hours

1. Swift to sustained-release morphine orally as background dose with immediate release morphine orally for breakthrough pain after successful titration of 24 hours.
2. Administration of morphine orally 1) Sustained-release morphine orally (dose/12 hours) = the total equianalgesic of the previous 24 hours/2×75% for d1; the total equianalgesic of the previous 24 hours/2 for day 2 and day 3; 2) Immediate release morphine orally = 10-20% of the total equianalgesic of the previous 24 hours; 3) Evaluate once every 24 hours

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 once every 24 hours

PCA IV Hydromorphone (continuous dose = 0)

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 once every 24 hours

PCA IV Hydromorphone (continuous dose ≠ 0)

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 d1; the total equianalgesic of the previous 24 hours/2 for day 2 and day 3; 2) Immediate release morphine orally = 10-20% of the total equianalgesic of the previous 24 hours; 3) Evaluate once every 24 hours

Oral morphine

Rongbo Lin, MD

Pain is one of the most common and fear symptoms for cancer patients, which seriously affects the quality of life in cancer patients. At present, oral opioid is the most common route to administrate cancer pain. However, the patients do not satisfy the pain administration with oral opioid after successful titration in many cases, especially the cases with severe cancer pain. Patient controlled analgesia (PCA) with hydromorphone can take analgesic effect rapidly. The aim of this trial is to compare the maintenance with hydromorphone PCA intravenously or switch to Sustained-Release Morphine orally after successful titraton with hydromorphone PCA intravenously in severe cancer pain.

Intravenous vs Oral Analgesia in Cancer Patients With Severe Pain After Successful Titration

Hydromorphone PCA Intravenously vs Sustained-Release Morphine Orally in Cancer Patients With Severe Pain After Successful Titration: A Multicenter, Randomized, Controlled, Phase II Trial

The Numerical Rating Scale (NRS, a score of 0 means no pain and 10 means the most severe) is used to assess the severity of pain. NRS of 24 hours is assessed every day. The mean pain score is a sum of NRS of day 1 (the day after successful titration of 24 hours) to day 3 divided by 3.

If the NRS of the morphine orally group \>3, the NRS in the hydromorphone PCA intravenously group declines more than 30% compared to morphine orally group, which is regards a positive result.

If NRS of the morphine orally group pain score ≤3 , or if NRS in the hydromorphone PCA intravenously group declines less than 30% compared to morphine orally group, number of Breakthrough cancer Pain (BTcP) episodes in the one of both the hydromorphone PCA intravenously group declines less than 30% compared to morphine orally group, which is regards a positive result.

The Numerical Rating Scale (NRS, a score of 0 means no pain and 10 means the most severe) is used to assess the severity of pain.

The total dosage of opioids in day 1 to day 3 (day 1 is the day after successful titration of 24 hours)

The satisfaction score of the patients to analgesia was evaluated by 10-point scale: 0 points for dissatisfaction, 10 points for very satisfied, the higher the score, the higher the satisfaction.

Chinese version of the Edmonton Symptom Assessment System.

The number of patients who switched/discontinued therapy due to serious adverse events or lack of pain control

Fujian Cancer Hospital

Pain, Intractable

Antitussive Agents

Respiratory System Agents

Anti-Obesity Agents

Vasoconstrictor Agents

Methadone

Phenylpropanolamine

Guaifenesin

Chlorpheniramine, phenylpropanolamine drug combination

oral methadone

Oral morphine is the active comparator. It is not a placebo intervention

oral morphine

Jordi Perez, MD

The research hypothesis of this study is: In patients with moderate to severe cancer related pain, the addition of low dose methadone to an existing opioid significantly reduces pain severity compared to low doses morphine.

Efficacy and Safety of Ultra-low Dose Methadone as Adjuvant Analgesic in Cancer Patients With Pain

A Double Blind Randomized Clinical Trial to Investigate the Efficacy and Safety of Ultra-low Dose Methadone as Adjuvant Analgesic Therapy in Cancer Patients With Pain

1. Demographic, cancer status, pain medication, symptom severity and side effects profile will be collected for each participant throughout the study
2. Data will be collected by clinical interview with research nurse
3. Data will be available to researchers immediately

Brief Pain Inventory: Composite questions 9-A to 9-G

1) Pain item of the Edmonton Symptom Assessment Scale

Questions 3 to 6 of the Brief Pain Inventory

prevalence and severity of opioid induced side effects

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Pilot Study of Ultra Rapid Opioid Rotation and Titration of Oxymorphone	NCT00945919	Chronic Nocicep... Neuropathic Pai... Non-cancer Pain	Oxymorphone ER	18 Years -	Icahn School of Medicine at Mount Sinai
Intravenous vs Oral Analgesia in Cancer Patients With Severe Pain After Successful Titration	NCT04243954	Cancer Pain	PCA IV Hydromor... PCA IV Hydromor... Oral morphine	18 Years - 80 Years	Fujian Cancer Hospital
A Pilot Study of Ultra Rapid Opioid Rotation and Titration of Oxymorphone	NCT00945919	Chronic Nocicep... Neuropathic Pai... Non-cancer Pain	Oxymorphone ER	18 Years -	Icahn School of Medicine at Mount Sinai
Efficacy and Safety of Ultra-low Dose Methadone as Adjuvant Analgesic in Cancer Patients With Pain	NCT02687347	Pain, Intractab...	oral methadone oral morphine	18 Years - 80 Years	McGill University Health Centre/Research Institute of the McGill University Health Centre

Spots Global Cancer Trial Database for oral morphine