Clinical trial · Interventional
Effectiveness of Opioid vs Pregabalin Plus Naproxen Sodium in Pain Management of Oral Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Oral Cavity Cancer | Malignant Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Oral Squamous Cell Carcinoma (OSCC) | Oral Cavity Squamous Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pregabalin + Naproxen Sodium | Drug | — | UNRESOLVED |
| Tramadol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group A Tramadol
- description
- Received oral tramadol 50 mg every 4 hours for pain management. Dose titration was done according to pain relief and tolerability. Treatment was continued for 7 days with clinical monitoring for pain response and adverse effects.
- interventionNames
- Drug: Tramadol
- type
- EXPERIMENTAL
- label
- Group B Pregabalin Plus Naproxen Sodium
- description
- Received oral pregabalin 75 mg twice daily along with oral naproxen sodium 550 mg twice daily for pain management. Treatment was continued for 7 days with clinical monitoring for pain response and adverse effects.
- interventionNames
- Drug: Pregabalin + Naproxen Sodium
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available