An interventional study of Tramadol and Pregabalin + Naproxen Sodium in Oral Cancer, Oral Cavity Cancer and Oral Squamous Cell Carcinoma (OSCC), sponsored by Mayo Hospital Lahore. Enrolling by invitation at 1 site in Pakistan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-26.
Sponsored by Mayo Hospital Lahore · Not applicable, Interventional, and Supportive care
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.
446 studies on the registry are indexed under Mouth Neoplasms; 130 are open to participants now.
This study's planned enrollment of 98 is above the median of 60 across 313 interventional studies indexed under Mouth Neoplasms.
Browse Mouth Neoplasms studies →Mayo Hospital Lahore is the lead sponsor of 16 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Tramadol
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.
Drug: Pregabalin + Naproxen Sodium
Oral tramadol 50 mg was administered every 4 hours for 7 days. Dose adjustment was made according to clinical response and tolerability.
Drug pages: Pregabalin · Naproxen
Oral pregabalin 75 mg was administered twice daily for 7 days. Oral naproxen sodium 550 mg was administered twice daily for 7 days.
Mean Change in Visual Analog Scale Pain Score From Baseline to Day 7
Pain intensity was assessed using the Visual Analog Scale, ranging from 0 to 10, where 0 indicated no pain and 10 indicated the worst imaginable pain. The mean change in pain score was calculated by subtracting the day 7 Visual Analog Scale score from the baseline Visual Analog Scale score. A greater positive change indicated greater reduction in pain intensity. The mean change was compared between the tramadol group and the pregabalin plus naproxen sodium group.
Time frame: Baseline and Day 7
Effective Pain Relief at Day 7
Effective pain relief was defined as at least 50% reduction in the baseline Visual Analog Scale pain score after 7 days of treatment. The proportion of participants achieving effective pain relief was compared between the two treatment groups.
Time frame: Baseline to Day 7
Severity of Adverse Events
The severity of adverse events was assessed using the Common Terminology Criteria for Adverse Events version 5.0. Events were categorized according to severity grade and compared between the treatment groups.
Time frame: Day 0 to Day 7
Started Feb 2026 (actual). Primary completion is estimated for Jul 2026, 5 months after the start.
Of 98 non-industry interventional studies with no phase under Mouth Neoplasms, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 97. This study's planned 5 months is below that.
Counting every sponsor, half of 99 studies reached it within 30 months; a quarter within 17 and three quarters within 107.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Pregabalin · Naproxen
Mayo Hospital Lahore