Rescue Emetic Therapy for Children Having Elective Surgery

NCT01067677 | Withdrawn

• 1 other identifier: 1-Cladis
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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. 1.Problem: Despite commonly-used anti-emetics for prophylaxis, some children still go on to develop post-operative vomiting (POV).
2. 2.Hypothesis: Anti-emetic medications that have a different mechanism of action than the prophylactic regimen will be the most efficacious "rescue therapy."
3. 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."

Conditions

Post Operative Nausea and Vomiting; Rescue Emetic Therapy

Keywords

PONV; Post operative nausea and vomiting; rescue emetic therapy

Outcome Measures

Primary Outcomes (1)

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

  48 hrs

Secondary Outcomes (3)

• 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

Study Arms (4)

Metoclopramide

EXPERIMENTAL

rescue emetic therapy

Drug: Metaclopramide

Ondansetron

EXPERIMENTAL

Rescue emetic therapy

Drug: Ondansetron

Diphenhydramine

EXPERIMENTAL

Rescue emetic therapy

Drug: diphenhydramine

Saline

PLACEBO COMPARATOR

Placebo

Drug: Saline

Interventions

Metaclopramide DRUG

0.5 mg/kg for rescue after PONV

Metoclopramide

Ondansetron DRUG

0.1 mg/kg (max 4 mg0

Ondansetron

diphenhydramine DRUG

0.25 mg/kg (max 25 mg)

Diphenhydramine

Saline DRUG

equal volume (5 ml)as experimental rescue medications

Saline

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Franklyn Cladis: lead

Study Sites (1)

The Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15210, United States

Location

MeSH Terms

Conditions

Vomiting; Postoperative Nausea and Vomiting

Interventions

Metoclopramide; Ondansetron; Diphenhydramine; Sodium Chloride

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Nausea

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Ethylamines; Amines; Benzhydryl Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Franklyn P Cladis, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 10, 2010
• First Posted: February 11, 2010
• Study Start: February 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2014
• Last Updated: November 14, 2017

Record last verified: 2017-11

Locations

US (1)