NCT01434017

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

Comparison of Three Different Prophylactic Treatments of PONV in Children

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Centre Hospitalier Universitaire Vaudois · Academic / Other
• Sex: All
• Age: 2 Years – 10 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Postoperative Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	Dexamethasone	Patients will receive dexamethasone 250 mcg/kg just after induction of anesthesia.
DRUG	Dexamethasone and droperidol	Patients will receive dexamethasone 250 mcg/kg + droperidol 10 mcg/kg just after induction of anesthesia.
DRUG	Dexamethasone and Ondansetron	Patients will receive dexamethasone 250 mcg/kg + ondansetron 150 mcg/kg just after induction of anesthesia.

Timeline

• Start date: 2008-11-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2011-09-14
• Last updated: 2014-02-27

Locations

1 site across 1 country: Switzerland