Brazilian Journal of Pain
https://brjp.org.br/article/doi/10.63231/2595-0118.202688-en
Brazilian Journal of Pain
Artigo Original

Feasibility of a randomised crossover trial comparing pre-emptive nimesulide plus tramadol versus dexamethasone in third molar surgery: pilot study

Viabilidade de um ensaio clínico randomizado crossover comparando nimesulida associada ao tramadol versus dexametasona na cirurgia de terceiros molares: estudo piloto

Sara Papaspyrou-Marques; Brender Leonan-Silva; Rafael Santiago de Almeida; Olga Beatriz Lopes Martins; Saulo Gabriel Moreira Falci

http://dx.doi.org/10.63231/2595-0118.202688-en BrJP, vol.9, e202688, 2026
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Abstract

BACKGROUND AND OBJECTIVES: Postoperative pain, trismus, and oedema are common complications following lower third molar extraction and may negatively affect patients' postoperative recovery. This pilot study aimed to assess the feasibility of conducting a randomised clinical trial comparing the pre-emptive efficacy of nimesulide 100 mg combined with tramadol hydrochloride 100 mg versus dexamethasone 8 mg in controlling postoperative pain, trismus, and oedema. Additionally, patients' stress and anxiety levels were evaluated before and after surgery.

METHODS: A randomised, triple-blind, crossover clinical design was employed. Five patients undergoing bilateral lower third molar extractions were assessed at 24, 48, and 72 hours, and 7 days postoperatively. Participants were randomly allocated to two treatment protocols: P1 – nimesulide 100 mg + tramadol hydrochloride 100 mg; and P2 – dexamethasone 8 mg + placebo. Stress and anxiety levels were assessed using the Hospital Anxiety and Depression Scale (HADS).

RESULTS: The mean age of the participants was 25.8 ± 4.49 years, comprising three (60%) women and two (40%) men. The mean surgical duration was 15 minutes. No statistically significant differences were observed between treatment protocols for postoperative pain. Significant changes over time were observed for trismus (p = 0.001 for dexamethasone and p = 0.046 for tramadol hydrochloride + nimesulide) and oedema (p = 0.033 for dexamethasone and p < 0.001 for tramadol hydrochloride + nimesulide), with dexamethasone demonstrating a more favourable anti-inflammatory profile. The study protocol proved feasible regarding recruitment, randomisation, and follow-up, supporting the viability of a larger-scale randomised controlled trial.

CONCLUSION: Within the limitations of this pilot study, nimesulide combined with tramadol exhibited satisfactory analgesic performance, while dexamethasone demonstrated a more favourable anti-inflammatory profile. The findings support the methodological feasibility of conducting a randomised clinical trial with a larger sample.

Keywords

Analgesia; Anti-inflammatory agents; Pain, Pilot projects; Third molar

Resumo

JUSTIFICATIVA E OBJETIVOS: A dor pós-operatória, o trismo e o edema são complicações frequentes após a exodontia de terceiros molares inferiores e podem afetar negativamente a recuperação dos pacientes. Este estudo piloto teve como objetivo avaliar a viabilidade de um ensaio clínico randomizado comparando os efeitos pré-emptivos da nimesulida 100 mg associada ao cloridrato de tramadol 100 mg versus dexametasona 8 mg no controle da dor pós-operatória, do trismo e do edema. Adicionalmente, foram avaliados os níveis de estresse e ansiedade dos pacientes antes e após a cirurgia.

MÉTODOS: Foi empregado um delineamento clínico randomizado, triplo-cego e crossover. Cinco pacientes submetidos à exodontia bilateral de terceiros molares inferiores foram avaliados em 24, 48 e 72 horas e após 7 dias do procedimento. Os participantes foram alocados aleatoriamente em dois protocolos de tratamento: P1 – nimesulida 100 mg + cloridrato de tramadol 100 mg; e P2 – dexametasona 8 mg + placebo. Os níveis de estresse e ansiedade foram avaliados por meio da Hospital Anxiety and Depression Scale (HADS).

RESULTADOS: A média de idade dos participantes foi de 25,8±4,49 anos, sendo três (60%) mulheres e dois (40%) homens. A duração média das cirurgias foi de 15 minutos. Não foram observadas diferenças estatisticamente significativas entre os protocolos de tratamento para a dor pós-operatória. Foram observadas diferenças significativas ao longo do tempo para o trismo (p=0,001 para dexametasona e p = 0,046 para cloridrato de tramadol + nimesulida) e o edema (p=0,033 para dexametasona e p<0,001 para cloridrato de tramadol + nimesulida), com a dexametasona demonstrando um perfil anti-inflamatório mais favorável. O protocolo do estudo mostrou-se viável quanto ao recrutamento, à randomização e ao acompanhamento, apoiando a realização de um ensaio clínico randomizado com amostra ampliada.

CONCLUSÃO: Dentro das limitações deste estudo piloto, a associação de nimesulida e tramadol apresentou desempenho analgésico satisfatório, enquanto a dexametasona demonstrou um perfil anti-inflamatório mais favorável. Os achados apoiam a viabilidade metodológica da realização de um ensaio clínico randomizado com uma amostra maior.

Palavras-chave

Analgesia; Anti-inflamatórios; Dor; Projeto piloto; Terceiro molar

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