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Sublingual Buprenorphine versus Oral Morphine for Controlling Breakthrough pain in Cancer Patients- A Comparative Study

Sublingual Buprenorphine versus Oral immediate-release Morphine for Controlling Breakthrough pain in Cancer Patients referred to Specialist Palliative Care Services- A phase II Randomized Controlled Study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/12/029950
Enrollment
30
Registered
2020-12-21
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C00-D49- Neoplasms

Interventions

Intervention1: Arm 1 Sublingual Buprenorphine: Tab.Buprenorphine sublingual 4th hourly equivalent of total daily oral morphine dose 1/6th of total daily Morphine dose. Conversion: 0.2 mg buprenorphine

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

India

Contacts

Public ContactDr Prasun P

Tata Memorial Hospital Mumbai

jukd2000@yahoo.co.uk9892358023

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026