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

N/AEnrolling By InvitationNCT07606638

Mayo Hospital Lahore98 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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