Rescue Emetic Therapy for Children Having Elective Surgery

Not Applicable

Withdrawn

• Conditions: Post Operative Nausea and Vomiting; Rescue Emetic Therapy
• Interventions: Drug: Saline; Drug: Metaclopramide; Drug: diphenhydramine; Drug: Ondansetron

• Registration Number: NCT01067677
• Lead Sponsor: Franklyn Cladis

Brief Summary

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."

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-10
• Study First Submitted QC: 2010-02-10
• Study First Posted: 2010-02-11
• Primary Completion: 2012-02
• Study Completion: 2014-02
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-12
• Last Update Posted: 2017-11-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	Saline	Placebo
Metoclopramide	Metaclopramide	rescue emetic therapy
Diphenhydramine	diphenhydramine	Rescue emetic therapy
Ondansetron	Ondansetron	Rescue emetic therapy

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

The Children's Hospital of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States