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

Study Overview
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Brief Summary
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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 Treatment group: acupuncture treatment (approximately 15 to 20 minutes) during anaesthesia and standard treatment 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

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

Conditions
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Postoperative Nausea and Vomiting, Postoperative Pain

Intervention / Treatment
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* Device: Acupuncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 11 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture and standard treatment<br>Acupuncture at Neiguan (Pericardium-6) bilaterally with Seirin needles no 3 (0.20x15 mm) to a depth of approximately 7 mm will be performed on the children immediately after induction of anaesthesia and removed before they are fully awake. Standard treatment: general anaesthesia | Device: Acupuncture<br> <br> |
| No Intervention: Standard treatment<br>General anaesthesia | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative nausea Postoperative vomiting Postoperative pain |  | Within 24 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, Children, Postoperative nausea and vomiting, Postoperative pain, Parental attitudes, Parental expectations