Postoperative Nausea and Vomiting and Acupuncture/Acupressure

Study Overview
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Brief Summary
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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: Treatment Group - standard treatment and acupuncture performed after induction of anaesthesia, acupressure administered before awakening Control Group - standard treatment 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.

Official Title
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Can Acustimulation Attenuate Postoperative Nausea and Vomiting in Children Who Have Undergone Tonsillectomy/Adenoidectomy?

Conditions
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Nausea, Postoperative Vomiting

Intervention / Treatment
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* Device: Acustimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children scheduled for tonsillectomy and/or adenoidectomy Informed consent from the parents/guardians Exclusion Criteria: ASA grade greater than or equal to III (patients with severe systemic disease) Rash or local infection over an acupuncture point Emesis during the previous 24 hours Use of medication with antiemetic effect and/or other antiemetic therapy within the 24 hours before surgery Gastric or intestinal diseases

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acustimulation<br> | Device: Acustimulation<br>* 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.<br>|
| No Intervention: Standard treatment group<br> | Device: Acustimulation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative nausea and vomiting |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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POV tonsillectomy adenoidectomy acupuncture acupressure child, Effectiveness of acupuncture on