Prevention of shivering post spinal anesthesia: Ondansetron vs. Nefopam ‒ a prospective randomized controlled trial
Prevenção do calafrio após anestesia raquidiana: Ondansetrona versus Nefopam ‒ um ensaio clínico randomizado prospectivo
Joanna Tohme, Joan Chehade, Hicham Abou Zeid, Rhea Mattar, Nicole Naccache, Khalil Jabbour, Mohammad Ali Ismail, Christine Dagher
Abstract
Background
Post Spinal Anesthesia Shivering (PSAS) is common and linked to increased morbidity. While various methods exist to prevent it, no study has compared Nefopam and Ondansetron. This study aims to compare Ondansetron and Nefopam in preventing PSAS.
Methods
A prospective, randomized, controlled, and double-blind trial was conducted in the operating room of a tertiary university hospital from April 5, 2021 to April 30, 2022. It included patients aged between 18 and 65 years scheduled for surgery under spinal anesthesia. Patients received either 8 mg of Ondansetron or 20 mg of Nefopam administered intravenously over 30 min before spinal anesthesia. Main outcome measures included the number and grades of shivering episodes post spinal anesthesia at 15-minute intervals until post-anesthesia care unit discharge. Secondary outcomes included number of episodes of hypotension, bradycardia, nausea and/or vomiting. Tympanic temperature and pain at the injection site were also recorded.
Results
The study included 150 patients, evenly divided between the two groups. The Ondansetron group had a higher incidence of shivering compared to the Nefopam group (23.9 % vs. 16 %; p = 0.038), as well as higher incidences of hypotension (16 % vs. 5.3 %; p = 0.035) and bradycardia (13.3 % vs. 2.7 %; p = 0.016). The Ondansetron group had a significantly lower incidence of nausea and vomiting (12 % vs. 1.3 %; p = 0.010). More patients in the Nefopam group (45.3 %) reported pain during drug infusion.
Conclusion
Nefopam seems to be more effective than Ondansetron in preventing PSAS with fewer cardiovascular side effects. However, Ondansetron reduces the incidence of nausea and
vomiting and causes no pain during administration.
Keywords
Resumo
Introdução
O Calafrio Pós-anestesia Raquidiana (PSAS) é comum e está associado a aumento da morbidade. Embora existam diversos métodos para preveni-lo, nenhum estudo comparou o Nefopam e a Ondansetrona. Este estudo teve como objetivo comparar Ondansetrona e Nefopam na prevenção do PSAS.
Métodos
Foi realizado um ensaio prospectivo, randomizado, controlado e duplo-cego na sala de cirurgia de um hospital universitário terciário entre 5 de abril de 2021 e 30 de abril de 2022. Incluiu pacientes entre 18 e 65 anos programados para cirurgia sob anestesia raquidiana. Os pacientes receberam 8 mg de Ondansetrona ou 20 mg de Nefopam administrados por via intravenosa durante 30 minutos antes da anestesia raquidiana. As principais medidas de desfecho incluíram o número e os graus dos episódios de calafrio após a anestesia raquidiana, avaliados a cada 15 minutos até a alta da unidade de cuidados pós-anestésicos. Desfechos secundários incluíram o número de episódios de hipotensão, bradicardia, náusea e/ou vômito. A temperatura timpânica e a dor no local da injeção também foram registradas.
Resultados
O estudo incluiu 150 pacientes, divididos igualmente entre os dois grupos. O grupo Ondansetrona apresentou maior incidência de calafrio comparado ao grupo Nefopam (23,9% vs. 16%; p = 0,038), assim como maiores incidências de hipotensão (16% vs. 5,3%; p = 0,035) e bradicardia (13,3% vs. 2,7%; p = 0,016). O grupo Ondansetrona apresentou incidência significativamente menor de náusea e vômito (12% vs. 1,3%; p = 0,010). Mais pacientes no grupo Nefopam (45,3%) relataram dor durante a infusão do medicamento.
Conclusão
O Nefopam parece ser mais eficaz que a Ondansetrona na prevenção do PSAS, com menos efeitos cardiovasculares adversos. Entretanto, a Ondansetrona reduz a incidência de náuseas e vômitos e não causa dor durante a administração.
Palavras-chave
Referências
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Submetido em:
25/12/2024
Aceito em:
29/05/2025
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