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NCT Number: NCT01434017

Comparison of Three Different Prophylactic Treatments of Postoperative Nausea and Vomiting (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).

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Key information

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre Hospitalier Universitaire Vaudois and University of Lausanne

Lausanne, Canton of Vaud, 1011, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

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

Dexamethasone and droperidol

Drug

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

Dexamethasone and Ondansetron

Drug

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

Primary outcomes

  1. Incidence of PONV after tonsillectomy with or without adenoidectomy

    Time frame: 48 hours

Secondary outcomes

  1. Incidence of side effects (extrapyramidal syndrome, hemorrhage, somnolence, headaches)

    Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Official study title

Comparison of Three Different Prophylactic Treatments of PONV in Children

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Sep 14, 2011
Registry last updated
Feb 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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