Rescue Emetic Therapy for Children Having Elective Surgery

Post Operative Nausea and Vomiting Clinical Trial

— RETCHES  

Official title:

Rescue Emetic Therapy for Children Having Elective Therapy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01067677
• Other study ID #: 1-Cladis
• Status: Withdrawn
• Phase: N/A
• First received: February 10, 2010
• Last updated: November 12, 2017
• Start date: February 2010
• Est. completion date: February 2014

Study information

• Verified date: November 2017
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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."

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2014
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Post Operative Nausea and Vomiting
• Postoperative Nausea and Vomiting
• Rescue Emetic Therapy
• Vomiting

Intervention

Drug:
• Metaclopramide
0.5 mg/kg for rescue after PONV
• Ondansetron
0.1 mg/kg (max 4 mg0
• diphenhydramine
0.25 mg/kg (max 25 mg)
• Saline
equal volume (5 ml)as experimental rescue medications

Locations

Country	Name	City	State
United States	The Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Franklyn Cladis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary-Incidence of POV after rescue antiemetic in PACU, car ride home, day of surgery, and POD #1 and 2		48 hrs
Secondary	Secondary - a. Discharge times		48 hrs
Secondary	Adverse events (headaches, sedation, dystonic reaction, dry mouth)		48 hrs
Secondary	POV risk factors. age, personal or family history of PONV, history of motion sickness, personal or family history of smoking		48 hrs