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Enrolling by Invitation

NCT Number: NCT07606638

Effectiveness of Opioid vs Pregabalin Plus Naproxen Sodium in Pain Management of Oral Cancer Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tramadol

Drug

Oral tramadol 50 mg was administered every 4 hours for 7 days. Dose adjustment was made according to clinical response and tolerability.

Pregabalin + Naproxen Sodium

Drug

Oral pregabalin 75 mg was administered twice daily for 7 days. Oral naproxen sodium 550 mg was administered twice daily for 7 days.

Primary outcomes

  1. Mean Change in Visual Analog Scale Pain Score From Baseline to Day 7

    Time frame: Baseline and 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.

Secondary outcomes

  1. Effective Pain Relief at Day 7

    Time frame: Baseline to 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.

  2. Severity of Adverse Events

    Time frame: Day 0 to Day 7

    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.

Sponsors and collaborators

Lead sponsor

Mayo Hospital Lahore

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 26, 2026
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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