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Rescue Emetic Therapy for Children Having Elective Surgery (RETCHES)

This study has been withdrawn prior to enrollment.
(We do not have the funding or resources to complete the study at this time)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01067677
First Posted: February 11, 2010
Last Update Posted: November 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Franklyn Cladis, University of Pittsburgh
  Purpose

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."

Condition Intervention
Post Operative Nausea and Vomiting Rescue Emetic Therapy Drug: Metaclopramide Drug: Ondansetron Drug: diphenhydramine Drug: Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rescue Emetic Therapy for Children Having Elective Therapy

Resource links provided by NLM:


Further study details as provided by Franklyn Cladis, University of Pittsburgh:

Primary Outcome Measures:
  • 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 Measures:
  • Secondary - a. Discharge times [ Time Frame: 48 hrs ]
  • Adverse events (headaches, sedation, dystonic reaction, dry mouth) [ Time Frame: 48 hrs ]
  • POV risk factors. age, personal or family history of PONV, history of motion sickness, personal or family history of smoking [ Time Frame: 48 hrs ]

Enrollment: 0
Study Start Date: February 2010
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metoclopramide
rescue emetic therapy
Drug: Metaclopramide
0.5 mg/kg for rescue after PONV
Experimental: Ondansetron
Rescue emetic therapy
Drug: Ondansetron
0.1 mg/kg (max 4 mg0
Experimental: Diphenhydramine
Rescue emetic therapy
Drug: diphenhydramine
0.25 mg/kg (max 25 mg)
Placebo Comparator: Saline
Placebo
Drug: Saline
equal volume (5 ml)as experimental rescue medications

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01067677


Locations
United States, Pennsylvania
The Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15210
Sponsors and Collaborators
Franklyn Cladis
Investigators
Principal Investigator: Franklyn P Cladis, MD University of Pittsburgh
  More Information

Responsible Party: Franklyn Cladis, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01067677     History of Changes
Other Study ID Numbers: 1-Cladis
First Submitted: February 10, 2010
First Posted: February 11, 2010
Last Update Posted: November 14, 2017
Last Verified: November 2017

Keywords provided by Franklyn Cladis, University of Pittsburgh:
PONV
Post operative nausea and vomiting
rescue emetic therapy

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Ondansetron
Diphenhydramine
Metoclopramide
Promethazine
Emetics
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents
Anesthetics, Local
Anesthetics