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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01434017

Enrollment

300

Registered

2011-09-14

Start date

2008-11-30

Completion date

2013-06-30

Last updated

2014-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Nausea and Vomiting

Keywords

PONV, Dexamethasone, Droperidol, Ondansetron, Tonsillectomy

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.

Interventions

DRUGDexamethasone

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

DRUGDexamethasone and droperidol

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

DRUGDexamethasone and Ondansetron

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

2 Years to 10 Years

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

Design outcomes

Primary

Measure	Time frame
Incidence of PONV after tonsillectomy with or without adenoidectomy	48 hours

Secondary

Measure	Time frame
Incidence of side effects (extrapyramidal syndrome, hemorrhage, somnolence, headaches)	48 hours

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026