Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: Buprenorphine Sublingual: Buprenorphine Sublingual 0.2 mcg Three times daily for 84 days
Control Intervention1: Tramadol Oral: Tramadol Oral 50 mg three times daily for 84 days
Sponsors
ICMR Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: Opioid-naive [ not taken any opioid analgesic before the start of the study], Diagnosed to have solid tumors, Suffering from moderate cancer pain [VAS pain of 4-7], who are assessed by the physician and have a life expectancy of more than 3 months attending the palliative and oncology units of trial centers
Exclusion criteria
Exclusion criteria: Patients who cannot swallow pills. Patients who are unreliable for follow-up and unable to self-record their pain scores. Patients who give refusal of consent. Patients who have a Life expectancy of lower than 3 months based on evaluation by the physician and performance score. All patients who have Contra-indication to adjuvants will be excluded from the study. Patients who have severe pain or are terminally ill, psychiatric patients, and patients having brain metastasis. Patients who require adjuvant analgesics other than gabapentin and paracetamol will be excluded from the study. Patients with severe hepatic or renal dysfunction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the analgesic efficacy of sublingual Buprenorphine against oral Tramadol by comparing the NRS pain score between two arms at 14 days after the intervention.Timepoint: 2 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the NRS Pain score between two arms of the study at 28days, 56 days, & 84 days after the intervention. To compare the adverse events between the two arms of the study using numerical opioid side effect scores & Current Opioid Misuse Measure at 14 days, 28 days,56 days & 84 days after the intervention.Timepoint: 28 days 56 days 84 days | — |
Countries
India
Contacts
Public ContactDr Rakesh L John
Amala Institute of Medical Sciences
Outcome results
None listed