- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- Mayo Hospital, Lahore
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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.
|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Rooshan Tahir Qazi, Mayo Hospital Lahore
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Munnsykdommer
- Stomatognatiske sykdommer
- Neoplasmer etter nettsted
- Neoplasmer
- Neoplasmer etter histologisk type
- Neoplasmer i hode og nakke
- Neoplasmer, kjertel og epitel
- Karsinom
- Karsinom, plateepitel
- Plateepitelkarsinom i hode og nakke
- Neoplasmer i munnen
- Aminosyrer, peptider og proteiner
- Organiske kjemikalier
- Lipider
- Hydrokarboner
- Hydrokarboner, syklisk
- Syrer, acyklisk
- Karboksylsyrer
- Naftalener
- Polysykliske aromatiske hydrokarboner
- Hydrokarboner, aromatisk
- Polysykliske forbindelser
- Aminer
- Aminosyrer
- Alkoholer
- Gamma-aminobutyric acid
- Aminobutyrates
- Butyrates
- Cyclohexanols
- Heksanoler
- Fet alkoholer
- Dimetylaminer
- Metylaminer
- Naftaleneddiksyrer
- Pregabalin
- Tramadol
- Naproxen
Andre studie-ID-numre
- Mayo6
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