Rescue Emetic Therapy for Children Having Elective Surgery (RETCHES)

Rescue Emetic Therapy for Children Having Elective Therapy

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."

Study Overview

• Status: Withdrawn
• Conditions: Post Operative Nausea and Vomiting; Rescue Emetic Therapy
• Intervention / Treatment: Drug: Metaclopramide; Drug: Ondansetron; Drug: diphenhydramine; Drug: Saline

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15210
      • The Children's Hospital of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Primary-Incidence of POV after rescue antiemetic in PACU, car ride home, day of surgery, and POD #1 and 2	48 hrs

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Franklyn Cladis
• Investigators: Principal Investigator: Franklyn P Cladis, MD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Anticipated): February 1, 2012
• Study Completion (Anticipated): February 1, 2014

Study Registration Dates

• First Submitted: February 10, 2010
• First Submitted That Met QC Criteria: February 10, 2010
• First Posted (Estimate): February 11, 2010

Study Record Updates

• Last Update Posted (Actual): November 14, 2017
• Last Update Submitted That Met QC Criteria: November 12, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: PONV; Post operative nausea and vomiting; rescue emetic therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Hypnotics and Sedatives; Anti-Anxiety Agents; Anesthetics, Local; Anti-Allergic Agents; Sleep Aids, Pharmaceutical; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Diphenhydramine; Promethazine; Ondansetron; Metoclopramide
• Other Study ID Numbers: 1-Cladis