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

Postoperative Nausea and Vomiting Clinical Trial

Official title:

Comparison of Three Different Prophylactic Treatments of PONV in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01434017
• Other study ID #: CHUV-51-08
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2011
• Last updated: February 26, 2014
• Start date: November 2008
• Est. completion date: June 2013

Study information

• Verified date: February 2014
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 10 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Dexamethasone
Patients will receive dexamethasone 250 mcg/kg just after induction of anesthesia.
• Dexamethasone and droperidol
Patients will receive dexamethasone 250 mcg/kg + droperidol 10 mcg/kg just after induction of anesthesia.
• Dexamethasone and Ondansetron
Patients will receive dexamethasone 250 mcg/kg + ondansetron 150 mcg/kg just after induction of anesthesia.

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois and University of Lausanne	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of PONV after tonsillectomy with or without adenoidectomy		48 hours	Yes
Secondary	Incidence of side effects (extrapyramidal syndrome, hemorrhage, somnolence, headaches)		48 hours	Yes