Chewing Gum for Prevention of Nausea and Vomiting After Elective Caesarean Section Under Spinal Anaesthesia: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 284
- 试验地点
- 1
- 主要终点
- The difference in the number of episodes of self-reported vomiting
研究概览
简要总结
Our study aims to determine if there is a difference in a self-reported incidence of nausea and vomiting in women who are given chewing gum following elective caesarean section under spinal anaesthesia compared to those who do not receive chewing gum
详细描述
Caesarean section is one of the most commonly performed surgical procedures worldwide and the rate continues to rise. It is most often performed under regional anaesthesia, like spinal or epidural with long acting opioids such as spinal morphine added to improve postoperative pain in the first 24 hours.
However, nausea and vomiting is a common side effect of spinal morphine. Other risk factors for nausea and vomiting are patient related (female, non-smoker, history of post-operative nausea and vomiting [PONV] and/or motion sickness) and surgery related (spinal induced hypotension, blood loss, vagal stimulation, uterine exteriorisation, uterotonics, i.v. opioids etc). Risk assessment tools are available to estimate the risk of PONV for each patient.
The incidence of post-caesarean section nausea and vomiting at Coombe Women and Infants University Hospital is 28% and worldwide rates range from 21%-79%.
In the context of Enhanced Recovery After Surgery (ERAS), experiencing nausea and vomiting is distressing, reduces patient satisfaction by delaying early eating, drinking and mobilisation, interrupts bonding with the baby and prolongs hospital discharge.
It has been demonstrated that chewing gum is not inferior to 4 mg Ondansetron in treating nausea and vomiting post breast and laparoscopic surgery in female patients. It also has been shown to improve the return of gastrointestinal function after major surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Spinal Anaesthesia
- •Able and Agreeable to chew chewing gum in recovery room and in the first 24 hours
- •Received Ondansetron 4mg IV intra-operatively
排除标准
- •Type 1 Diabetes Mellitus
- •Nausea and/or Vomiting on arrival to recovery room
- •Post-partum haemorrhage >1000ml
- •Ergometrine or Misoprostol intra-operatively
- •Intravenous opioid intra-operatively
研究组 & 干预措施
Control
Patients will receive the standard dose of anti-emetic according to hospital practice (Ondansetron 4mg IV, intra-operatively)
干预措施: Ondansetron 4 MG (Drug)
Chewing Gum
Patients will receive the standard dose of anti-emetic according to hospital practice (Ondansetron 4mg IV, intra-operatively) they will also receive chewing in the recovery room and on the post-natal ward.
干预措施: Chewing Gum (Other)
Chewing Gum
Patients will receive the standard dose of anti-emetic according to hospital practice (Ondansetron 4mg IV, intra-operatively) they will also receive chewing in the recovery room and on the post-natal ward.
干预措施: Ondansetron 4 MG (Drug)
结局指标
主要结局
The difference in the number of episodes of self-reported vomiting
时间窗: 24 hours post caesarean section
Self-reported number of episodes of vomiting described to investigator
The difference in the number of episodes of self-reported nausea
时间窗: 24 hours post caesarean section
Self-reported nausea described to investigator
次要结局
- Antiemetics in the first 24 hours after Caesarean section under spinal anaesthesia(24 hours post caesarean section)
- Patient satisfaction with the intervention(24 hours post caesarean section)
- Episodes of nausea, vomiting or both in recovery room and at 24 hours after caesarean section.(24 hours post caesarean section)
- Severity of nausea, reported as the worst episode in the last 24 hours(24 hours post caesarean section)
研究者
Petar Popivanov
Principal Investigator
Coombe Women and Infants University Hospital