NCT01729052

Acupuncture for Postoperative Nausea, Vomiting and Pain in Children: The Implication of Parental Attitudes

The Effect of Acupuncture for Alleviation of Postoperative Nausea, Vomiting, and Pain in Children: The Implications of Parental Attitudes and Expectations

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 282 (actual)
• Sponsor: University of Tromso · Academic / Other
• Sex: All
• Age: 2 Years – 11 Years
• Healthy volunteers: Not accepted

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

Conditions

• Postoperative Nausea and Vomiting
• Postoperative Pain

Interventions

Type	Name	Description
DEVICE	Acupuncture

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2012-11-20
• Last updated: 2013-09-19