Sublingual Buprenorphine versus Oral Morphine for Controlling Breakthrough pain in Cancer Patients- A Comparative Study
- Conditions
- Health Condition 1: C00-D49- Neoplasms
- Registration Number
- CTRI/2020/12/029950
- Lead Sponsor
- A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Age >18 years.
2.Cancer patients referred to or following up specialist palliative care services in the clinic or on home care.
3.History of breakthrough pain (as assessed by Davies Algorithm) and not taking rescue doses.
4.Patient receiving oral morphine for treatment of background pain.
5.Current prescribed oral morphine dose 60mg - 180mg/day for background pain but not taking rescue doses for BTcP.
6.Patient at the time of screening visit experience his/her current BTcP episodes to be severe enough that he/she will require additional analgesia.
7.Willing to take part in the study
8.Patients residing in Mumbai for a period of 2 weeks after recruitment into study/baseline assessment.
1.Patients on opioid detoxification programme or Opioid Substitution Therapy
2.Patients on combination opioid therapy
3.Contra-indications to buprenorphine ie. hypersensitivity to Buprenorphine
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain intensity difference at 30 minutes after rescue dose of study drug in both arms-as measured by the scores on the Numerical Rating ScaleTimepoint: 0 minutes and 30 minutes after rescue dose of the study drug
- Secondary Outcome Measures
Name Time Method Pain Intensity Difference at 15,30,45 and 60 minutes after rescue dose of the study drug from 0 minutes in both arms as measured by scores on NRSTimepoint: 0,15,45,60 minutes