Rescue Emetic Therapy for Children Having Elective Surgery

Withdrawn before enrolling · Not applicable

Conditions studied: Post Operative Nausea and Vomiting, Rescue Emetic Therapy

In brief

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."

Key facts

Study ID

NCT01067677

Run by

Franklyn Cladis

People needed

0

Starts

2010-02-01

Expected to finish

2014-02-01

Last updated by the study team

2017-11-14

Who can join

Age: 3 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Pediatric patients 3-17 years old
• Patients scheduled for tonsillectomy and/or adenoidectomy (with and without myringotomy) , or dental restoration,
• Patients receiving a general anesthetic (inhaled agent without nitrous oxide) with POV prophylaxis with two agents (ondansetron and dexamethasone)
• Post operative vomiting in PACU or second stage recovery requiring antiemetic rescue.

You may not qualify if…

• Vomiting in the past 24 hours or antiemetics in previous 24 hours
• Allergy or sensitivity to ondansetron, dexamethasone, metoclopramide, or diphenhydramine
• Patients with diabetes
• Patients with seizures
• Patients receiving a benzodiazepine premedication

Where it is running

• The Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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