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

Vaud University Hospital Center

Status and phase: Completed; Phase 4

Conditions: Postoperative Nausea and Vomiting

Treatments: Drug: Dexamethasone and Ondansetron; Drug: Dexamethasone and droperidol; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT01434017

CHUV-51-08

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 300 patients

Sex: All

Ages: 2 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 3 patient groups

Dexamethasone

Active Comparator group

Description:

Patients will receive dexamethasone 250 mcg/kg just after induction of anesthesia.

Treatment:

Drug: Dexamethasone

Dexamethasone and Droperidol

Active Comparator group

Description:

Patients will receive dexamethasone 250 mcg/kg + droperidol 10 mcg/kg just after induction of anesthesia.

Treatment:

Drug: Dexamethasone and droperidol

Dexamethasone and Ondansetron

Active Comparator group

Description:

Patients will receive dexamethasone 250 mcg/kg + ondansetron 150 mcg/kg just after induction of anesthesia.

Treatment:

Drug: Dexamethasone and Ondansetron