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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Mean Change in Visual Analog Scale Pain Score From Baseline to Day 7 [Срок оценки: Baseline and Day 7]

Вторичные конечные точки (2)

• Effective Pain Relief at Day 7 [Срок оценки: Baseline to Day 7]
• Severity of Adverse Events [Срок оценки: Day 0 to Day 7]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Пакистан · 1 центр

• Mayo Hospital, Lahore — Lahore

Идентификаторы

NCT: NCT07606638 · Mayo6

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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