The Effect of Acupuncture for Alleviation of Postoperative Nausea, Vomiting, and Pain in Children: The Implications of Parental Attitudes and Expectations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 282
- 主要终点
- Postoperative nausea Postoperative vomiting Postoperative pain
研究概览
简要总结
Postoperative nausea and vomiting (PONV) remain a significant challenge in our practice. However, pharmaceutical prophylaxis is only partially effective and can imply unpleasant adverse effects. Accordingly, the use of non-pharmacological methods in preventing PONV is appropriate. Acupuncture is reported to reduce PONV and pain, and the adverse events are minimal.
The objective of this multicentre, double-blinded, randomized, controlled trial is to investigate whether acupuncture can be a supplementary to the ordinary treatment in children undergoing tonsillectomy and/or adenoidectomy. In addition, the non-specific effect of parental attitudes and expectations on the outcomes will be explored.
Two hundred and eighty patients will be included and randomized into two groups
- Treatment group: acupuncture treatment (approximately 15 to 20 minutes) during anaesthesia and standard treatment
- Control group: standard treatment
The primary endpoints in the intervention study are nausea, retching, vomiting and pain during 24 hours postoperatively. The effect of acupuncture will be studied with regard to any association with possible factors of predisposition to PONV, as well as with other factors registered during the study. Adverse events from acupuncture will be registered.
The objective of the self-report questionnaires is to
- investigate parental attitudes and expectations to the acupuncture treatment pre- and postoperatively
- compare data of the outcomes from the intervention trial with data from the questionnaires, in order to find any correlation between parental beliefs, attitudes and expectations, and the effect of the acupuncture treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children from two to eleven years of age
- •Children scheduled for tonsillectomy and/or adenoidectomy
- •Informed consent from the parents
排除标准
- •American Society of Anesthesiologists grade greater than or equal to III (patient with severe systemic disease)
- •Patients/parents in need of an interpreter
- •Rash or local infection over an acupuncture point
- •Emesis during the previous 24 hours
- •Use of medication with antiemetic effect within the 24 hours before surgery
- •Gastric or intestinal diseases
结局指标
主要结局
Postoperative nausea Postoperative vomiting Postoperative pain
时间窗: Within 24 hours postoperatively
次要结局
未报告次要终点