Anesthesiology · 2024
Chewing Gum to Treat Postoperative Nausea and Vomiting in Female Patients: A Multicenter Randomized Trial.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеEquivalence TrialНазвание и аннотация: Перевод в очереди
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Darvall Jai N, De Silva Anurika P, von Ungern-Sternberg Britta, Story David A, Davidson Andrew J, Allen Megan L, Tran-Duy An, Schultz-Ferguson Cindy, Ha Vi, Braat Sabine, Leslie Kate, CHEWY Trial Group and the ANZCA Clinical Trials Network
Аннотация
BACKGROUND: Postoperative nausea and vomiting is common after general anesthesia, with consequences for patient outcomes, satisfaction with care, and healthcare costs. The aim was to compare a new treatment, chewing gum, with a widely used intravenous agent, ondansetron, to treat postoperative nausea and vomiting in female patients in the postanesthesia care unit.
METHODS: This study was a multicenter, randomized, controlled noninferiority trial in 17 hospitals in Australia and New Zealand. Female patients aged 12 yr or older undergoing volatile anesthetic-based general anesthesia for laparoscopic or breast surgery were enrolled. Protocolized antiemetic prophylaxis was administered. Patients who developed postoperative nausea and vomiting in the postanesthesia care unit were randomized to either 15 min of chewing gum or 4 mg intravenous ondansetron. The primary outcome was cessation of nausea, retching, or vomiting with no recurrence nor rescue medication for 2 h after administration of the randomized intervention ( i.e. , complete response).
RESULTS: Of 865 enrolled patients, 218 were randomized. In a per-protocol analysis, 50 of 105 (47.6%) ondansetron-treated patients compared with 31 of 103 (30.1%) chewing gum-treated patients achieved the primary outcome (absolute risk difference [95% CI], -17.3 [-30.4 to -4.3]%), not reaching the prespecified noninferiority limit. The time to complete response was longer for patients randomized to chewing gum (hazard ratio [95% CI], 0.53 [0.34 to 0.83]), and they were more likely to receive antiemetics in the 24 h after surgery (absolute risk difference [95% CI], 14.1 [1.6 to 26.5]%).
CONCLUSIONS: Chewing gum cannot be recommended as an alternative to ondansetron for treatment of postoperative nausea and vomiting in female patients administered antiemetic prophylaxis.
METHODS: This study was a multicenter, randomized, controlled noninferiority trial in 17 hospitals in Australia and New Zealand. Female patients aged 12 yr or older undergoing volatile anesthetic-based general anesthesia for laparoscopic or breast surgery were enrolled. Protocolized antiemetic prophylaxis was administered. Patients who developed postoperative nausea and vomiting in the postanesthesia care unit were randomized to either 15 min of chewing gum or 4 mg intravenous ondansetron. The primary outcome was cessation of nausea, retching, or vomiting with no recurrence nor rescue medication for 2 h after administration of the randomized intervention ( i.e. , complete response).
RESULTS: Of 865 enrolled patients, 218 were randomized. In a per-protocol analysis, 50 of 105 (47.6%) ondansetron-treated patients compared with 31 of 103 (30.1%) chewing gum-treated patients achieved the primary outcome (absolute risk difference [95% CI], -17.3 [-30.4 to -4.3]%), not reaching the prespecified noninferiority limit. The time to complete response was longer for patients randomized to chewing gum (hazard ratio [95% CI], 0.53 [0.34 to 0.83]), and they were more likely to receive antiemetics in the 24 h after surgery (absolute risk difference [95% CI], 14.1 [1.6 to 26.5]%).
CONCLUSIONS: Chewing gum cannot be recommended as an alternative to ondansetron for treatment of postoperative nausea and vomiting in female patients administered antiemetic prophylaxis.