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A study the efficacy and safety of oral morphine versus sublingual buprenorphine for treatment of cancer pain in head and neck cancer patients

Efficacy and safety of oral morphine versus sublingual buprenorphine in treatment of cancer pain for head and neck cancer patients - A prospective randomized control trial - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/108454
Enrollment
84
Registered
2026-04-15
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Health Condition 1: D10- Benign neoplasm of mouth and pharynx

Interventions

Intervention1: MORPHINE (oral): Given 4 hourly ( according to titrated doses for 24 hours) Control Intervention1: BUPRENORPHINE (Sublingual): Given 12 hourly (according to equipotent doses of titrated

Sponsors

Geetanjali Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)All the admitted patient with locally advanced head and neck cancer having moderate to severe cancer pain (NRS greater than 5) and inadequate relief with adequate doses of step 2 (tramadol) analgesics. Patients in age group 18 years to 70 years of either gender. Patients who have given informed written consent will be included in this study.

Exclusion criteria

Exclusion criteria: Contraindication and allergic to study drugs, Patients with severe cardiac, respiratory, hepatic, or renal disease, malabsorption syndrome Patients with history of substance abuse such as tobacco/ opioid ,etc, Patients who received strong opioid analgesics over past 1month, Patient on use of pain reduction techniques such as nerve block over past 3 months, Patients having distant metastasis, Patient having psychiatric disorder, Patient with severe nausea and vomiting.

Design outcomes

Primary

MeasureTime frame
Pain intensity using Numeric Rating Scale The Incidence of Breakthrough Pain and number of rescue doses of oral morphine (5mg) Clinical profile of symptom severity using Edmonton Symptom Assessment ScaleTimepoint: Every 4th hourly over 1st 24 hours and then on 3rd day, 7th day and 14th day.—

Secondary

MeasureTime frame
Quality of life using :- The World Health Organization Quality Of Life (WHOQOL) Timepoint: day 0, 7 and 14;The physical status using :- Eastern Cooperative Oncology Group (ECOG) Performance StatusTimepoint: Day 0,7 and 14;a) Adverse effects like nausea, vomiting, pruritus and drowsiness. (b)Bowel Function Index to assess constipationTimepoint: day 7 and 14.—

Countries

India

Contacts

Public ContactTanya Varma

Geetanjali Medical College and Hospital

Partaniseema@yahoo.in9414162150

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026