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

19. maj 2026 opdateret af: Adeel Ahmed, Mayo Hospital Lahore

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.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

98

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • Mayo Hospital, Lahore

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Group A Tramadol
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.
Oral tramadol 50 mg was administered every 4 hours for 7 days. Dose adjustment was made according to clinical response and tolerability.
Eksperimentel: Group B Pregabalin Plus Naproxen Sodium
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.
Oral pregabalin 75 mg was administered twice daily for 7 days. Oral naproxen sodium 550 mg was administered twice daily for 7 days.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Change in Visual Analog Scale Pain Score From Baseline to Day 7
Tidsramme: 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.
Baseline and Day 7

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Effective Pain Relief at Day 7
Tidsramme: 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.
Baseline to Day 7
Severity of Adverse Events
Tidsramme: 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.
Day 0 to Day 7

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Rooshan Tahir Qazi, Mayo Hospital Lahore

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. februar 2026

Primær færdiggørelse (Anslået)

30. juli 2026

Studieafslutning (Anslået)

30. juli 2026

Datoer for studieregistrering

Først indsendt

19. maj 2026

Først indsendt, der opfyldte QC-kriterier

19. maj 2026

Først opslået (Faktiske)

26. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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