NCT01067677

Rescue Emetic Therapy for Children Having Elective Surgery

Rescue Emetic Therapy for Children Having Elective Therapy

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Franklyn Cladis · Academic / Other
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Accepted

Summary

To compare ondansetron, metoclopramide, diphenhydramine, and placebo in order to determine which anti-emetic is most efficacious as a "rescue therapy" for pediatric patients ages 3-18 who have post-operative vomiting after a standardized prophylactic regimen of ondansetron and dexamethasone. We hypothesize that anti-emetics with a different mechanism of action than the prophylactic regimen will be the most effective "rescue therapy" in children having surgery in an ambulatory surgery center. 1. Problem: Despite commonly-used anti-emetics for prophylaxis, some children still go on to develop post-operative vomiting (POV). Goal: To determine which anti-emetic--ondansetron, metoclopramide, diphenhydramine, or placebo--is most efficacious for pediatric patients in this situation. 2. Hypothesis: Anti-emetic medications that have a different mechanism of action than the prophylactic regimen will be the most efficacious "rescue therapy." 3. Hypothesis: Metoclopramide at the dose of 0.5 mg/kg (max dose 20 mg) will be more effective than ondansetron, diphenhydramine, or placebo as "rescue therapy."

Conditions

• Post Operative Nausea and Vomiting
• Rescue Emetic Therapy

Interventions

Type	Name	Description
DRUG	Metaclopramide	0.5 mg/kg for rescue after PONV
DRUG	Ondansetron	0.1 mg/kg (max 4 mg0
DRUG	diphenhydramine	0.25 mg/kg (max 25 mg)
DRUG	Saline	equal volume (5 ml)as experimental rescue medications

Timeline

• Start date: 2010-02-01
• Primary completion: 2012-02-01
• Completion: 2014-02-01
• First posted: 2010-02-11
• Last updated: 2017-11-14

Locations

1 site across 1 country: United States