An interventional study of Metaclopramide and Ondansetron in Post Operative Nausea and Vomiting and Rescue Emetic Therapy, sponsored by Franklyn Cladis. Withdrawn at 1 site in United States. Open to participants aged 3 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-14.
Sponsored by Franklyn Cladis · Not applicable, Interventional, and Treatment
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.
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.
822 studies on the registry are indexed under Nausea; 104 are open to participants now.
Browse Nausea studies →This is the only study on the registry with Franklyn Cladis as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
rescue emetic therapy
Drug: Metaclopramide
Rescue emetic therapy
Drug: Ondansetron
Rescue emetic therapy
Drug: diphenhydramine
Placebo
Drug: Saline
0.5 mg/kg for rescue after PONV
0.1 mg/kg (max 4 mg0
0.25 mg/kg (max 25 mg)
equal volume (5 ml)as experimental rescue medications
Primary-Incidence of POV after rescue antiemetic in PACU, car ride home, day of surgery, and POD #1 and 2
Time frame: 48 hrs
Secondary - a. Discharge times
Time frame: 48 hrs
Adverse events (headaches, sedation, dystonic reaction, dry mouth)
Time frame: 48 hrs
POV risk factors. age, personal or family history of PONV, history of motion sickness, personal or family history of smoking
Time frame: 48 hrs
This study is withdrawn, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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