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

NCT07606638 | Enrolling By Invitation

• 1 other identifier: Mayo6
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

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

Oral Cancer; Oral Cavity Cancer; Oral Squamous Cell Carcinoma (OSCC)

Keywords

Oral cancer pain; Cancer pain management; Oral cavity neoplasms; Mouth neoplasms; Oral squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Day 7

Secondary Outcomes (2)

• Effective Pain Relief at Day 7

  Baseline to Day 7

• Severity of Adverse Events

  Day 0 to Day 7

Study Arms (2)

Group A Tramadol

ACTIVE COMPARATOR

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

Group B Pregabalin Plus Naproxen Sodium

EXPERIMENTAL

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

Interventions

Tramadol DRUG

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

Group A Tramadol

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.

Group B Pregabalin Plus Naproxen Sodium

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Hospital Lahore: lead

Study Sites (1)

Mayo Hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Mouth Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Tramadol; Pregabalin; Naproxen

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Amino Acids; Amino Acids, Peptides, and Proteins; Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Rooshan Tahir Qazi

  Mayo Hospital Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 26, 2026
• Study Start: February 1, 2026
• Primary Completion: July 30, 2026
• Study Completion: July 30, 2026
• Last Updated: May 26, 2026

Record last verified: 2026-05

Locations

PA (1)