Comparison of Three Different Prophylactic Treatments of Postoperative Nausea and Vomiting (PONV) in Children

Study Overview
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Brief Summary
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Incidence of postoperative nausea and vomiting (PONV) in children after tonsillectomy with or without adenoidectomy may be as high as 75%. Several medications may prevent and treat PONV, such as steroids, antidopaminergic drugs and serotonin (5-HT3) antagonists. The objective of this study is to compare three prophylactic antiemetic treatments: dexamethasone alone (250 mcg/kg) dexamethasone (250 mcg/kg) + droperidol (10 mcg/kg) dexamethasone (250 mcg/kg) + ondansetron (150 mcg/kg).

Detailed Description
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Tonsillectomy with or without adenoidectomy may be associated with severe postoperative nausea and vomiting (PONV). Causes are principally trigeminal nerve stimulation and presence of blood in the stomach. Consequences are disagreement, unsatisfactory, delayed discharge, and overnight admission in day-cases. More barely, patients may also have suture and esophagus rupture, aspiration of gastric contents, dehydration and electrolyte disturbances. Several medications may prevent and treat PONV, such as steroids, antidopaminergic drugs and serotonin (5-HT3) antagonists. The objective of this study is to compare three prophylactic antiemetic treatments: dexamethasone alone (250 mcg/kg) dexamethasone (250 mcg/kg) + droperidol (10 mcg/kg) dexamethasone (250 mcg/kg) + ondansetron (150 mcg/kg). The hypothesis is that the combination of dexamethasone and droperidol is as effective as the combination of dexamethasone and ondansetron, both of them being more effective than dexamethasone alone. Moreover, droperidol is cheaper than ondansetron and may be recommended as a first-line treatment.

Official Title
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Comparison of Three Different Prophylactic Treatments of PONV in Children

Conditions
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Postoperative Nausea and Vomiting

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Dexamethasone and droperidol
* Drug: Dexamethasone and Ondansetron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children aged 2-10 y. children ASA 1-2 weight > 15 kg tonsillectomy with or without adenoidectomy Exclusion Criteria: intravenous induction contraindication to steroids contraindication to antidopaminergic drugs contraindication to serotoninergic antagonists administration of steroids, antidopaminergic drugs, or serotoninergic antagonists in the 24 hours before the surgery refusal of parents no-french speaking parents

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 10 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 dexamethasone 250 mcg/kg just after induction of anesthesia. | Drug: Dexamethasone<br>* Patients will receive dexamethasone 250 mcg/kg just after induction of anesthesia.<br>|
| Active Comparator: Dexamethasone and Droperidol<br>Patients will receive dexamethasone 250 mcg/kg + droperidol 10 mcg/kg just after induction of anesthesia. | Drug: Dexamethasone and droperidol<br>* Patients will receive dexamethasone 250 mcg/kg + droperidol 10 mcg/kg just after induction of anesthesia.<br>|
| Active Comparator: Dexamethasone and Ondansetron<br>Patients will receive dexamethasone 250 mcg/kg + ondansetron 150 mcg/kg just after induction of anesthesia. | Drug: Dexamethasone and Ondansetron<br>* Patients will receive dexamethasone 250 mcg/kg + ondansetron 150 mcg/kg just after induction of anesthesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of PONV after tonsillectomy with or without adenoidectomy |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of side effects (extrapyramidal syndrome, hemorrhage, somnolence, headaches) |  | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PONV, Dexamethasone, Droperidol, Ondansetron, Tonsillectomy