Postoperative Nausea and Vomiting Clinical Trial
Official title:
Comparison of Three Different Prophylactic Treatments of PONV in Children
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).
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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