Prevention of POV After Paediatric Tonsillectomy

Study Overview
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Brief Summary
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Tonsillectomy is one of the most frequently performed surgical procedures in children. It remains associated with a high morbidity related to postoperative vomiting (POV), pain, risk of bleeding, and dehydration due to impaired oral intake. Current medications for POV have limited efficacy and may even be associated with potential side-effects. Non-pharmacological techniques such as acupuncture has been investigated as alternatives to antiemetics and as additional treatment modalities for POV.

Detailed Description
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Postoperative vomiting (POV) is one of the most common complication in children undergoing tonsillectomy. Its incidence is between 62% and 73% when no prophylactic antiemetic is given. Because of Limited efficacy and side effects with antiemetics, many alternative treatment had been used. Acupuncture is simple, inexpensive, and noninvasive with minimal side effects. The objective of this study is to compare two prophylactic antiemetic treatments : Dexamethasone (0.15 mg/kg) immediately after induction of anaesthesia Acupuncture treatment (immediately after induction of anaesthesia and for approximately 20 minutes)

Official Title
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Vomiting After Tonsillectomy in Children: A Comparison of Dexamethasone and Acupuncture

Conditions
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Vomiting

Intervention / Treatment
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* Drug: Dexamethasone
* Device: Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children aged 2-8 y. children ASA 1-2 tonsillectomy with or without adenoidectomy Exclusion Criteria: American Society of Anesthesiologists grade greater than or equal to III (patient with severe systemic disease) intravenous induction contraindication to steroids Rash or local infection over an acupuncture point administration of steroids in the 24 hours before the surgery Use of medication with antiemetic effect within the 24 hours before surgery Gastric or intestinal diseases refusal of parents

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 8 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexamethasone<br>Patients will receive Intravenous dexamethasone 0.15 mg/kg immediately after induction of anesthesia. | Drug: Dexamethasone<br>* Patients will receive Intravenous dexamethasone 0.15 mg/kg immediately after induction of anesthesia.<br>|
| Active Comparator: Acupuncture<br>Acupuncture at point Neiguan (Pericardium-6) bilaterally and at point CV13 (Shang Wen) with acupuncture needles (0.25x25 mm) to a depth of approximately 7 mm will be performed on the children immediately after induction of anaesthesia and removed after 20 minutes | Device: Acupuncture<br>* Acupuncture treatment (just after induction of anaesthesia and for approximately 20 minutes)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of POV after tonsillectomy with or without adenoidectomy | by 3 point ordinal scale | 24 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tonsillectomy, postoperative vomiting (POV), Dexamethasone, Acupuncture