Rescue Emetic Therapy for Children Having Elective Surgery (RETCHES)

Franklyn Cladis

Status: Withdrawn

Conditions: Rescue Emetic Therapy; Post Operative Nausea and Vomiting

Treatments: Drug: Ondansetron; Drug: Metaclopramide; Drug: diphenhydramine; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01067677

1-Cladis

Details and patient eligibility

About

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.

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."

Sex: All

Ages: 3 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Pediatric patients 3-17 years old
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

1. Vomiting in the past 24 hours or antiemetics in previous 24 hours
2. Allergy or sensitivity to ondansetron, dexamethasone, metoclopramide, or diphenhydramine
3. Patients with diabetes
4. Patients with seizures
5. Patients receiving a benzodiazepine premedication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 4 patient groups, including a placebo group

Metoclopramide

Experimental group

Description:

rescue emetic therapy

Treatment:

Drug: Metaclopramide

Ondansetron

Experimental group

Description:

Rescue emetic therapy

Treatment:

Drug: Ondansetron

Diphenhydramine

Experimental group

Description:

Rescue emetic therapy

Treatment:

Drug: diphenhydramine

Saline

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Saline