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Rescue Emetic Therapy for Children Having Elective Surgery (RETCHES)

Primary Purpose

Post Operative Nausea and Vomiting, Rescue Emetic Therapy

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Metaclopramide

Ondansetron

diphenhydramine

Saline

About this trial

This is an interventional treatment trial for Post Operative Nausea and Vomiting focused on measuring PONV, Post operative nausea and vomiting, rescue emetic therapy

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

The Children's Hospital of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Metoclopramide

Ondansetron

Diphenhydramine

Saline

Arm Description

rescue emetic therapy

Rescue emetic therapy

Placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01067677

First Posted

February 10, 2010

Last Updated

November 12, 2017

Sponsor

Franklyn Cladis

1. Study Identification

Unique Protocol Identification Number

NCT01067677

Brief Title

Rescue Emetic Therapy for Children Having Elective Surgery

Acronym

RETCHES

Official Title

Rescue Emetic Therapy for Children Having Elective Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Withdrawn

Why Stopped

We do not have the funding or resources to complete the study at this time

Study Start Date

February 2010 (undefined)

Primary Completion Date

February 2012 (Anticipated)

Study Completion Date

February 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Franklyn Cladis

4. Oversight

Data Monitoring Committee

5. Study Description

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. 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."

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post Operative Nausea and Vomiting, Rescue Emetic Therapy

Keywords

PONV, Post operative nausea and vomiting, rescue emetic therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Metoclopramide

Arm Type

Experimental

Arm Description

rescue emetic therapy

Arm Title

Ondansetron

Arm Type

Experimental

Arm Description

Rescue emetic therapy

Arm Title

Diphenhydramine

Arm Type

Experimental

Arm Description

Rescue emetic therapy

Arm Title

Saline

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

Metaclopramide

Intervention Description

0.5 mg/kg for rescue after PONV

Intervention Type

Drug

Intervention Name(s)

Ondansetron

Intervention Description

0.1 mg/kg (max 4 mg0

Intervention Type

Drug

Intervention Name(s)

diphenhydramine

Intervention Description

0.25 mg/kg (max 25 mg)

Intervention Type

Drug

Intervention Name(s)

Saline

Intervention Description

equal volume (5 ml)as experimental rescue medications

Primary Outcome Measure Information:

Title

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

Time Frame

48 hrs

Secondary Outcome Measure Information:

Title

Secondary - a. Discharge times

Time Frame

48 hrs

Title

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

Time Frame

48 hrs

Title

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

Time Frame

48 hrs

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Franklyn P Cladis, MD

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Children's Hospital of Pittsburgh

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15210

Country

United States

12. IPD Sharing Statement

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Rescue Emetic Therapy for Children Having Elective Surgery

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