A Phase 2/3 interventional study of Acustimulation in Postoperative Vomiting and Nausea, sponsored by National Research Centre of Complementary and Alternative Medicine, Norway. Completed at 1 site in Norway. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2009-08-25.
Sponsored by National Research Centre of Complementary and Alternative Medicine, Norway · Phase 2/3, Interventional, and Supportive care
Postoperative nausea and vomiting (PONV) remain a significant challenge in the investigators practice. However, pharmaceutical prophylaxis can imply unpleasant adverse effects. It would therefore be appropriate to consider the use of non-pharmacological methods in preventing PONV. Acupuncture and acupressure are reported to be effective preventive treatment for PONV, and the adverse effects are minimal.
Consequently, the investigators will investigate if acupuncture and acupressure can be implemented as a supplementary to the ordinary treatment in children undergoing surgery for tonsillectomy and/or adenoidectomy. The study will also focus on the feasibility for acupuncture and acupressure in the operation theatre. The study and inclusion/exclusion decisions are conducted after the "intention-to-treat" principle. 126 patients are included, divided into two groups:
The primarily endpoints in this study are nausea, retching and vomiting. The effect of acupuncture/acupressure 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 effects from the acupuncture site and wristband will be registered.
822 studies on the registry are indexed under Nausea; 104 are open to participants now.
This study's enrollment of 154 is above the median of 115 across 703 interventional studies indexed under Nausea.
Browse Nausea studies →National Research Centre of Complementary and Alternative Medicine, Norway is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Device: Acustimulation
Device: Acustimulation
Acupressure in P6 bilaterally given after induction of anaesthesia for 20 minutes, followed by acupressure wrist bands applied on the same acupoints for 24 hours.
Postoperative nausea and vomiting
Time frame: 24 hours
The effect of the intervention will be studied with regard to any association with possible factors of predisposition to PONV. Adverse effects will also be registered.
Time frame: 24 hours
This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.
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National Research Centre of Complementary and Alternative Medicine, Norway