Rescue Emetic Therapy for Children Having Elective Surgery (RETCHES)
Recruitment status was: Recruiting
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."
|Post Operative Nausea and Vomiting Rescue Emetic Therapy||Drug: Metaclopramide Drug: Ondansetron Drug: diphenhydramine Drug: Saline|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Rescue Emetic Therapy for Children Having Elective Therapy|
- 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 ]
|Study Start Date:||February 2010|
|Estimated Study Completion Date:||February 2014|
|Estimated Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01067677
|Contact: Franklyn P Cladis, MDemail@example.com|
|United States, Pennsylvania|
|The Children's Hospital of Pittsburgh||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15210|
|Contact: Franklyn P Cladis, MD 412-692-5260 firstname.lastname@example.org|
|Principal Investigator: Franklyn P Cladis, MD|
|Sub-Investigator: Kathy Fertal, RN|
|Sub-Investigator: Slava Martyn|
|Sub-Investigator: Susan Woelfel, MD|
|Sub-Investigator: Neal Campbell, MD|
|Principal Investigator:||Franklyn P Cladis, MD||University of Pittsburgh|