Effectiveness of Opioid vs Pregabalin Plus Naproxen Sodium in Pain Management of Oral Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tramadol, Pregabalin + Naproxen Sodium.
- Who it may be relevant to
- Registry conditions: Oral Cancer, Oral Cavity Cancer, Oral Squamous Cell Carcinoma (OSCC). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This randomized clinical study was designed to compare two pain treatment approaches for adults with oral cancer who had moderate to severe pain. Oral cancer pain may occur because of tumor growth, local tissue damage, inflammation, ulceration, or nerve involvement. Standard pain treatment often includes opioid medicines, but these medicines may cause side effects such as sedation, nausea, constipation, dizziness, tolerance, or dependence. In some patients, pain may also have a nerve-related or inflammatory component, where medicines such as pregabalin and naproxen sodium may provide additional benefit. A total of 98 eligible adult patients with histopathology-confirmed oral cancer and a baseline Visual Analog Scale pain score of 4 or more were included. Patients were randomly assigned into two treatment groups. One group received oral tramadol 50 mg every 4 hours, with dose adjustment according to pain relief and tolerability. The other group received oral pregabalin 75 mg twice daily with naproxen sodium 550 mg twice daily. Both treatments were given for 7 days under clinical monitoring. Pain intensity was measured using the Visual Analog Scale at baseline, day 3, and day 7. The main outcome was the mean reduction in pain score from baseline to day 7. Effective pain relief was defined as at least 50% reduction in the baseline pain score after 7 days of treatment. Side effects such as sedation, nausea or vomiting, constipation, dizziness, and gastrointestinal discomfort were also recorded. Patient satisfaction with pain control was assessed at the end of treatment.
Interventions
- Drug Tramadol
Oral tramadol 50 mg was administered every 4 hours for 7 days. Dose adjustment was made according to clinical response and tolerability. - Drug Pregabalin + Naproxen Sodium
Oral pregabalin 75 mg was administered twice daily for 7 days. Oral naproxen sodium 550 mg was administered twice daily for 7 days.
Primary outcome measures
- Mean Change in Visual Analog Scale Pain Score From Baseline to Day 7 [Time frame: Baseline and Day 7]
Secondary outcome measures (2)
- Effective Pain Relief at Day 7 [Time frame: Baseline to Day 7]
- Severity of Adverse Events [Time frame: Day 0 to Day 7]
Eligibility criteria
Inclusion criteria
- Patients aged 18 years or older
- Histopathology confirmed diagnosis of oral cancer
- Experiencing moderate to severe pain (VAS ≥ 4)
- Either opioid-naïve or off opioids for at least one week
- Able to provide informed consent
Exclusion criteria
- Known allergy to morphine, pregabalin, or NSAIDs
- History of renal impairment, gastrointestinal bleeding, or peptic ulcer disease
- Concurrent use of other strong analgesics
- Psychiatric illness or cognitive impairment interfering with pain assessment
- Pregnancy or lactation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
Pakistan · 1 center
- Mayo Hospital, Lahore — Lahore
Identifiers
NCT: NCT07606638 · Mayo6