Health Condition 1: C15-C26- Malignant neoplasms of digestive organs
Conditions
Interventions
Intervention1: Evaluation of efficacy of combination of low dose oral Methadone syrup with Morphine tablets for pain in patients of Gastrointestinal cancers.: Analgesic optimization with the combinati
Sponsors
Dr BRA IRCH , All India institute of Medical Sciences, New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: Patients aged between 18 and 65 years Patients with the diagnosis of Gastrointestinal cancers with abdominal pain on opioids Patients for whom the pain is not adequately managed which is NRS less than 4 with 60 mg of Morphine per day are recruited into the study Patient with the ability to provide informed consent and is willing to comply with study procedure and follow up visits and recruited into the study Patients belonging to ECOG physical status classification I II and III are recruited into the study
Exclusion criteria
Exclusion criteria: 1. Patients with contraindications to Methadone like (Hypersensitivity, Acute or Severe bronchial asthma, Paralytic ileus, Uncontrolled mental illness, Pregnancy, Severe Hepatic impairment, History of conduction heart disorders, significant arrhythmias, heart block). 2. Inability to provide informed consent or comply with study procedures. 3. Patient taking other opioids like Fentanyl. 4. Patients who are on drugs which causes QTc prolongation (Antimalarials, Moxifloxacin, Antidepressants, Antipsychotics , Antiarrhythmics, Fluconazole Etc.,) 5. Patients who are on drugs affecting cytochrome metabolism ( Protease inhibitors , Rifampicin , Ketoconazole etc.,) 6. Patients with significant dyselectrolytemia. 7. Old and frail patients, terminally ill patients who have less probability of being alive till the end of the study duration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GI cancer pain is measured Numerical Rating Scale and compared between 2 groups.Timepoint: Upon OPD visits at Presentation, 1st week, 2nd week, and 4th week. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the side effect profile of combination of low dose Methadone with Morphine and Morphine alone for pain management in Gastrointestinal cancers.Timepoint: Patients will be evaluated at 1 week, 2 week and 1 month.;To evaluate whether the addition of Low dose methadone with Morphine decreases the total opioid consumption.Timepoint: Patients will be evaluated at 1 week, 2 week and 1 month. | — |
Countries
India
Contacts
Public ContactDr Sachidanand Jee Bharati
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed