Rescue Emetic Therapy for Children Having Elective Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Rescue Emetic Therapy for Children Having Elective Therapy

Conditions
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Post Operative Nausea and Vomiting, Rescue Emetic Therapy

Intervention / Treatment
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* Drug: Metaclopramide
* Drug: Ondansetron
* Drug: diphenhydramine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric patients 3-17 years old Patients scheduled for tonsillectomy and/or adenoidectomy (with and without myringotomy) , or dental restoration, Patients receiving a general anesthetic (inhaled agent without nitrous oxide) with POV prophylaxis with two agents (ondansetron and dexamethasone) Post operative vomiting in PACU or second stage recovery requiring antiemetic rescue. Exclusion Criteria: Vomiting in the past 24 hours or antiemetics in previous 24 hours Allergy or sensitivity to ondansetron, dexamethasone, metoclopramide, or diphenhydramine Patients with diabetes Patients with seizures Patients receiving a benzodiazepine premedication

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metoclopramide<br>rescue emetic therapy | Drug: Metaclopramide<br>* 0.5 mg/kg for rescue after PONV<br>|
| Experimental: Ondansetron<br>Rescue emetic therapy | Drug: Ondansetron<br>* 0.1 mg/kg (max 4 mg0<br>|
| Experimental: Diphenhydramine<br>Rescue emetic therapy | Drug: diphenhydramine<br>* 0.25 mg/kg (max 25 mg)<br>|
| Placebo Comparator: Saline<br>Placebo | Drug: Saline<br>* equal volume (5 ml)as experimental rescue medications<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary-Incidence of POV after rescue antiemetic in PACU, car ride home, day of surgery, and POD #1 and 2 |  | 48 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary - a. Discharge times |  | 48 hrs | 
| Adverse events (headaches, sedation, dystonic reaction, dry mouth) |  | 48 hrs | 
| POV risk factors. age, personal or family history of PONV, history of motion sickness, personal or family history of smoking |  | 48 hrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PONV, Post operative nausea and vomiting, rescue emetic therapy