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Clinical trialNCT01067677WithdrawnInterventional

Rescue Emetic Therapy for Children Having Elective Surgery

SponsorFranklyn CladisEnrollment0Post Operative Nausea and VomitingRescue Emetic Therapy
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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."

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

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Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • the Children'S Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
28 Feb 2010
Primary completion
29 Feb 2012
Completion
28 Feb 2014
Last update posted
14 Nov 2017
Registered enrollment
0
Registry id
NCT01067677

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 11 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.