Chewing gum to treat postoperative nausea and emesis in female patients (CHEWY): rationale and design for a multicentre randomised trial.

作者: Jai Darvall , Britta Sylvia von Ungern-Sternberg , Sabine Braat , David Story , Andrew Davidson

DOI: 10.1136/BMJOPEN-2018-027505

关键词:

摘要: Introduction Postoperative nausea, retching and vomiting (PONV) remains one of the most common side effects general anaesthesia, contributing significantly to patient dissatisfaction, cost complications. Chewing gum has potential as a novel, drug-free alternative treatment. We aim conduct large, definitive randomised controlled trial efficacy safety peppermint-flavoured chewing treat PONV in postanaesthesia care unit (PACU). If is shown be effective ondansetron, this improve outcomes for tens millions surgical patients around world each year. Methods analysis This prospective, multicentre, non-inferiority trial. 272 female aged ≥12 years having volatile anaesthetic-based anaesthesia breast or laparoscopic surgery will randomised. Patients experiencing PACU 15 min 4 mg intravenous ondansetron. The primary outcome (complete response) cessation within 2 hours administration, with no recurrence nor rescue medication requirement after administration. Ethics dissemination Chewy Trial been approved by Human Research Committees at all sites. Dissemination via international national conferences, publication peer-reviewed literature. registration number ACTRN12618000429257; Pre-results.

参考文章(30)
DORIS A. CHERNIK, DENNIS GILLINGS, HARRIET LAINE, JUDITH HENDLER, JONATHAN M. SILVER, ARNOLD B. DAVIDSON, ELIAS M. SCHWAM, JUDITH L. SIEGEL, Validity and reliability of the Observer's Assessment of Alertness/Sedation Scale: study with intravenous midazolam. Journal of Clinical Psychopharmacology. ,vol. 10, pp. 244- 251 ,(1990) , 10.1097/00004714-199008000-00003
Faranak Kazemi-Kjellberg, Iris Henzi, Martin R Tramèr, Treatment of established postoperative nausea and vomiting: a quantitative systematic review BMC Anesthesiology. ,vol. 1, pp. 2- 2 ,(2001) , 10.1186/1471-2253-1-2
Vaneesha Short, Georgia Herbert, Rachel Perry, Charlotte Atkinson, Andrew R Ness, Christopher Penfold, Steven Thomas, Henning Keinke Andersen, Stephen J Lewis, None, Chewing gum for postoperative recovery of gastrointestinal function Cochrane Database of Systematic Reviews. ,vol. 2, ,(2015) , 10.1002/14651858.CD006506.PUB3
Peter A. Stark, Paul S. Myles, Justin A. Burke, Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. ,vol. 118, pp. 1332- 1340 ,(2013) , 10.1097/ALN.0B013E318289B84B
Reitze N. Rodseth, P. Dean Gopalan, Hussein M. Cassimjee, Saaliha Goga, Reduced incidence of postoperative nausea and vomiting in black South Africans and its utility for a modified risk scoring system. Anesthesia & Analgesia. ,vol. 110, pp. 1591- 1594 ,(2010) , 10.1213/ANE.0B013E3181DA9005
Yong H. Kim, Kyo S. Kim, Hee J. Lee, Jae C. Shim, Sung W. Yoon, The efficacy of several neuromuscular monitoring modes at the P6 acupuncture point in preventing postoperative nausea and vomiting. Anesthesia & Analgesia. ,vol. 112, pp. 819- 823 ,(2011) , 10.1213/ANE.0B013E31820F819E
Thomas G Weiser, Alex B Haynes, George Molina, Stuart R Lipsitz, Micaela M Esquivel, Tarsicio Uribe-Leitz, Rui Fu, Tej Azad, Tiffany E Chao, William R Berry, Atul A Gawande, Estimate of the global volume of surgery in 2012: an assessment supporting improved health outcomes The Lancet. ,vol. 385, pp. S11- ,(2015) , 10.1016/S0140-6736(15)60806-6
Samia Khalil, Alexander Rodarte, Craig B. Weldon, Michael Weinstein, Zvi Grunwald, Brian Ginsberg, Robert Kaye, Alice Otto, Melissa Wheeler, David C. Lawhorn, Barbara A. Prillaman, Mary Creed, , Intravenous Ondansetron in Established Postoperative Emesis in Children Anesthesiology. ,vol. 85, pp. 270- 276 ,(1996) , 10.1097/00000542-199608000-00007
Matthew Bodner, Paul F. White, Antiemetic efficacy of ondansetron after outpatient laparoscopy. Anesthesia & Analgesia. ,vol. 73, pp. 250- 254 ,(1991) , 10.1213/00000539-199109000-00003
Peter Kranke, Leopold H.J. Eberhart, Possibilities and limitations in the pharmacological management of postoperative nausea and vomiting. European Journal of Anaesthesiology. ,vol. 28, pp. 758- 765 ,(2011) , 10.1097/EJA.0B013E32834A4E1E