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Rescue Emetic Therapy for Children Having Elective Surgery (RETCHES)

This study is currently recruiting participants.
Verified September 2009 by Children's Hospital of Pittsburgh
Sponsor:
Information provided by:
Children's Hospital of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01067677
First received: February 10, 2010
Last updated: June 21, 2011
Last verified: September 2009
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rescue Emetic Therapy for Children Having Elective Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's Hospital 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 ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 1600
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

Ages Eligible for Study:   3 Years to 18 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01067677

Contacts
Contact: Franklyn P Cladis, MD 412-692-5260 cladfp@upmc.edu

Locations
United States, Pennsylvania
The Children's Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15210
Contact: Franklyn P Cladis, MD     412-692-5260     cladfp@upmc.edu    
Principal Investigator: Franklyn P Cladis, MD            
Sub-Investigator: Kathy Fertal, RN            
Sub-Investigator: Slava Martyn            
Sub-Investigator: Susan Woelfel, MD            
Sub-Investigator: Neal Campbell, MD            
Sponsors and Collaborators
Children's Hospital of Pittsburgh
Investigators
Principal Investigator: Franklyn P Cladis, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Franklyn Cladis MD, University of Pittsburgh, Department of Anesthesiology
ClinicalTrials.gov Identifier: NCT01067677     History of Changes
Other Study ID Numbers: 1-Cladis
Study First Received: February 10, 2010
Last Updated: June 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital 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
Diphenhydramine
Metoclopramide
Ondansetron
Promethazine
Emetics
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Allergic Agents
Anesthetics, Local
Anesthetics

ClinicalTrials.gov processed this record on May 19, 2013