Clinical trial NCT01434017: Comparison of Three Different Prophylactic Treatments of Postoperative Nausea and Vomiting (PONV) in Children
Official title: Comparison of Three Different Prophylactic Treatments of PONV in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Nausea and Vomiting
Keywords: PONV
Dexamethasone
Droperidol
Ondansetron
Tonsillectomy
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2011-09-14
Enrollment: 300
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of PONV after tonsillectomy with or without adenoidectomy
timeFrame: 48 hours
Secondary outcomes:
measure: Incidence of side effects (extrapyramidal syndrome, hemorrhage, somnolence, headaches)
timeFrame: 48 hours
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois and University of Lausanne
state: Vaud
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois
name: Eric Albrecht
role: PRINCIPAL_INVESTIGATOR
References: