Rescue Emetic Therapy for Children Having Elective Surgery
NCT ID: NCT01067677
Last Updated: 2017-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2010-02-28
2014-02-28
Brief Summary
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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."
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Metoclopramide
rescue emetic therapy
Metaclopramide
0.5 mg/kg for rescue after PONV
Ondansetron
Rescue emetic therapy
Ondansetron
0.1 mg/kg (max 4 mg0
Diphenhydramine
Rescue emetic therapy
diphenhydramine
0.25 mg/kg (max 25 mg)
Saline
Placebo
Saline
equal volume (5 ml)as experimental rescue medications
Interventions
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Metaclopramide
0.5 mg/kg for rescue after PONV
Ondansetron
0.1 mg/kg (max 4 mg0
diphenhydramine
0.25 mg/kg (max 25 mg)
Saline
equal volume (5 ml)as experimental rescue medications
Eligibility Criteria
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Inclusion Criteria
2. Patients scheduled for tonsillectomy and/or adenoidectomy (with and without myringotomy) , or dental restoration,
3. Patients receiving a general anesthetic (inhaled agent without nitrous oxide) with POV prophylaxis with two agents (ondansetron and dexamethasone)
4. Post operative vomiting in PACU or second stage recovery requiring antiemetic rescue.
Exclusion Criteria
2. Allergy or sensitivity to ondansetron, dexamethasone, metoclopramide, or diphenhydramine
3. Patients with diabetes
4. Patients with seizures
5. Patients receiving a benzodiazepine premedication
3 Years
18 Years
ALL
Yes
Sponsors
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Franklyn Cladis
OTHER
Responsible Party
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Franklyn Cladis
Associate Professor
Principal Investigators
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Franklyn P Cladis, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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The Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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1-Cladis
Identifier Type: -
Identifier Source: org_study_id
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