Rescue Emetic Therapy for Children Having Elective Surgery

Condition(s) targeted: Post Operative Nausea and Vomiting; Rescue Emetic Therapy

Intervention: Metaclopramide (Drug); Ondansetron (Drug); diphenhydramine (Drug); Saline (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Children's Hospital of Pittsburgh

Official(s) and/or principal investigator(s):
Franklyn P Cladis, MD, Principal Investigator, Affiliation: University of Pittsburgh

Overall contact:
Franklyn P Cladis, MD, Phone: 412-692-5260, Email: cladfp@upmc.edu

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."

Official title: Rescue Emetic Therapy for Children Having Elective Therapy

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Primary-Incidence of POV after rescue antiemetic in PACU, car ride home, day of surgery, and POD #1 and 2

Secondary outcome:

Secondary - a. Discharge times

Adverse events (headaches, sedation, dystonic reaction, dry mouth)

POV risk factors. age, personal or family history of PONV, history of motion sickness, personal or family history of smoking

Minimum age: 3 Years. Maximum age: 18 Years. Gender(s): Both.

Criteria:

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

Franklyn P Cladis, MD, Phone: 412-692-5260, Email: cladfp@upmc.edu

The Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania 15210, United States; Recruiting
Franklyn P Cladis, MD, Phone: 412-692-5260, Email: cladfp@upmc.edu
Franklyn P Cladis, MD, Principal Investigator
Kathy Fertal, RN, Sub-Investigator
Slava Martyn, Sub-Investigator
Susan Woelfel, MD, Sub-Investigator
Neal Campbell, MD, Sub-Investigator

Starting date: February 2010
Last updated: June 21, 2011