Postoperative Pain Clinical Trial
Official title:
The Effect of Acupuncture for Alleviation of Postoperative Nausea, Vomiting, and Pain in Children: The Implications of Parental Attitudes and Expectations
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
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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