Rescue Emetic Therapy for Children Having Elective Surgery (RETCHES)
|ClinicalTrials.gov Identifier: NCT01067677|
Recruitment Status : Withdrawn (We do not have the funding or resources to complete the study at this time)
First Posted : February 11, 2010
Last Update Posted : November 14, 2017
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.
- Hypothesis: Anti-emetic medications that have a different mechanism of action than the prophylactic regimen will be the most efficacious "rescue therapy."
- 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."
|Condition or disease||Intervention/treatment||Phase|
|Post Operative Nausea and Vomiting Rescue Emetic Therapy||Drug: Metaclopramide Drug: Ondansetron Drug: diphenhydramine Drug: Saline||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Rescue Emetic Therapy for Children Having Elective Therapy|
|Study Start Date :||February 2010|
|Estimated Primary Completion Date :||February 2012|
|Estimated Study Completion Date :||February 2014|
rescue emetic therapy
0.5 mg/kg for rescue after PONV
Rescue emetic therapy
0.1 mg/kg (max 4 mg0
Rescue emetic therapy
0.25 mg/kg (max 25 mg)
Placebo Comparator: Saline
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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01067677
|United States, Pennsylvania|
|The Children's Hospital of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15210|
|Principal Investigator:||Franklyn P Cladis, MD||University of Pittsburgh|