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Rescue Emetic Therapy for Children Having Elective Surgery

NCT ID: NCT01067677

Last Updated: 2017-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2014-02-28

Brief Summary

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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

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Conditions

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Post Operative Nausea and Vomiting Rescue Emetic Therapy

Keywords

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PONV Post operative nausea and vomiting rescue emetic therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Metoclopramide

rescue emetic therapy

Group Type EXPERIMENTAL

Metaclopramide

Intervention Type DRUG

0.5 mg/kg for rescue after PONV

Ondansetron

Rescue emetic therapy

Group Type EXPERIMENTAL

Ondansetron

Intervention Type DRUG

0.1 mg/kg (max 4 mg0

Diphenhydramine

Rescue emetic therapy

Group Type EXPERIMENTAL

diphenhydramine

Intervention Type DRUG

0.25 mg/kg (max 25 mg)

Saline

Placebo

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

equal volume (5 ml)as experimental rescue medications

Interventions

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Metaclopramide

0.5 mg/kg for rescue after PONV

Intervention Type DRUG

Ondansetron

0.1 mg/kg (max 4 mg0

Intervention Type DRUG

diphenhydramine

0.25 mg/kg (max 25 mg)

Intervention Type DRUG

Saline

equal volume (5 ml)as experimental rescue medications

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Franklyn Cladis

OTHER

Sponsor Role lead

Responsible Party

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Franklyn Cladis

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Franklyn P Cladis, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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The Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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1-Cladis

Identifier Type: -

Identifier Source: org_study_id