Effectiveness of Opioid vs Pregabalin Plus Naproxen Sodium in Pain Management of Oral Cancer Patients
Enrolling by invitation · Not applicable
Conditions studied: Oral Cancer, Oral Cavity Cancer, Oral Squamous Cell Carcinoma (OSCC)
In brief
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.
Key facts
- Study ID
- NCT07606638
- Run by
- Mayo Hospital Lahore
- People needed
- 98
- Starts
- 2026-02-01
- Expected to finish
- 2026-07-30
- Last updated by the study team
- 2026-05-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Mayo Hospital, Lahore — Lahore, Punjab Province, Pakistan
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.