- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Punjab Province
-
Lahore, Punjab Province, Paquistão, 54000
- Mayo Hospital, Lahore
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: 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.
|
|
Experimental: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Mean Change in Visual Analog Scale Pain Score From Baseline to Day 7
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Effective Pain Relief at Day 7
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Rooshan Tahir Qazi, Mayo Hospital Lahore
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças bucais
- Doenças estomatognáticas
- Neoplasias por local
- Neoplasias
- Neoplasias por Tipo Histológico
- Neoplasias de Cabeça e Pescoço
- Neoplasias Glandulares e Epiteliais
- Carcinoma
- Carcinoma de Células Escamosas
- Carcinoma Espinocelular de Cabeça e Pescoço
- Neoplasias Bucais
- Aminoácidos, peptídeos e proteínas
- Produtos químicos orgânicos
- Lipídios
- Hidrocarbonetos
- Hidrocarbonetos, cíclicos
- Ácidos, acíclico
- Ácidos carboxílicos
- Naftalenos
- Hidrocarbonetos aromáticos policíclicos
- Hidrocarbonetos, aromáticos
- Compostos policíclicos
- Aminas
- Aminoácidos
- Álcoons
- Ácido gama-aminobutírico
- Aminobutiratos
- Butyrates
- Ciclohexanóis
- Hexanóis
- Álcoois gordurosos
- Dimetilaminas
- Metilaminas
- Ácidos naftaleneacéticos
- Pregabalina
- Tramadol
- Naproxeno
Outros números de identificação do estudo
- Mayo6
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