Postoperative Nausea and Vomiting, Postoperative Pain
Conditions
Keywords
Acupuncture, Children, Postoperative nausea and vomiting, Postoperative pain, Parental attitudes, Parental expectations
Brief summary
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 1. Treatment group: acupuncture treatment (approximately 15 to 20 minutes) during anaesthesia and standard treatment 2. 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
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
* Children from two to eleven years of age * Children scheduled for tonsillectomy and/or adenoidectomy * Informed consent from the parents
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative nausea Postoperative vomiting Postoperative pain | Within 24 hours postoperatively |
Other
| Measure | Time frame |
|---|---|
| Parental attitudes Parental expectations | Within 24 hours postoperatively |