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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eric Albrecht, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier:
NCT01434017
First received: September 13, 2011
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

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).

Condition Intervention Phase
Postoperative Nausea and Vomiting
Drug: Dexamethasone
Drug: Dexamethasone and droperidol
Drug: Dexamethasone and Ondansetron
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison of Three Different Prophylactic Treatments of PONV in Children

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Vaudois:

Primary Outcome Measures:
  • Incidence of PONV after tonsillectomy with or without adenoidectomy [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of side effects (extrapyramidal syndrome, hemorrhage, somnolence, headaches) [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Enrollment: 300
Study Start Date: November 2008
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dexamethasone
Patients will receive dexamethasone 250 mcg/kg just after induction of anesthesia.
Drug: Dexamethasone
Patients will receive dexamethasone 250 mcg/kg just after induction of anesthesia.
Active Comparator: Dexamethasone and Droperidol
Patients will receive dexamethasone 250 mcg/kg + droperidol 10 mcg/kg just after induction of anesthesia.
Drug: Dexamethasone and droperidol
Patients will receive dexamethasone 250 mcg/kg + droperidol 10 mcg/kg just after induction of anesthesia.
Active Comparator: Dexamethasone and Ondansetron
Patients will receive dexamethasone 250 mcg/kg + ondansetron 150 mcg/kg just after induction of anesthesia.
Drug: Dexamethasone and Ondansetron
Patients will receive dexamethasone 250 mcg/kg + ondansetron 150 mcg/kg just after induction of anesthesia.

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

Ages Eligible for Study:   2 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01434017

Locations
Switzerland
Centre Hospitalier Universitaire Vaudois and University of Lausanne
Lausanne, Vaud, Switzerland, 1011
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Investigators
Principal Investigator: Eric Albrecht Centre Hospitalier Universitaire Vaudois
  More Information

No publications provided

Responsible Party: Eric Albrecht, MD, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT01434017     History of Changes
Other Study ID Numbers: CHUV-51-08
Study First Received: September 13, 2011
Last Updated: February 26, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by Centre Hospitalier Universitaire Vaudois:
PONV
Dexamethasone
Droperidol
Ondansetron
Tonsillectomy

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Dexamethasone acetate
Dexamethasone
Droperidol
Ondansetron
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 10, 2014