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Ondansetron Reduce Vomiting Associated With Ketamine PSA

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ClinicalTrials.gov Identifier: NCT00387556
Recruitment Status : Completed
First Posted : October 13, 2006
Last Update Posted : May 13, 2013
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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Brief Summary:
Ondansetron, a commonly used anti-vomiting medication, may reduce the occurrence of vomiting associated with ketamine during procedural sedation in the pediatric emergency department.

Condition or disease Intervention/treatment Phase
Conscious Sedation Drug: Ondansetron Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Does Ondansetron Reduce the Incidence of Vomiting When Used in Conjunction With Ketamine During Procedural Sedation in the Pediatric Emergency Department
Study Start Date : December 2002
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Ketamine + Ondansetron
ketamine 1 mg/kg IV (maximum single dose 100 mg)+ondansetron (0.15 mg/kg/dose; maximum dose 4 mg)
 Drug: Ondansetron
ondansetron (0.15 mg/kg/dose; maximum dose 4 mg)
Other Name: Zofran
Placebo Comparator: Ketamine + Placebo
ketamine 1 mg/kg IV (maximum single dose 100 mg)+2 ml normal saline solution IV (placebo
 Drug: Ondansetron
ondansetron (0.15 mg/kg/dose; maximum dose 4 mg)
Other Name: Zofran


Outcome Measures
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Primary Outcome Measures :
  1. incidence of vomiting [ Time Frame: Duration of ED stay and after discharge ]
    The primary outcomes in this study were vomiting in the ED and after discharge, as determined by telephone follow-up


Secondary Outcome Measures :
  1. Length of ED stay [ Time Frame: Duration of ED stay ]
    Secondary outcome measures were length of ED stay

  2. Satisfaction with Sedation [ Time Frame: Length of ED stay. ]
    patient or parent satisfaction with their sedation


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 1-21 years, ASA I or II, fracture of dislocation reduction

Exclusion Criteria:

  • age < 1 year, ASA III or IV, hypertension, glaucoma, acute globe injury, increased intracranial pressure or central nervous system mass lesion, major psychiatric disorder, porphyria, previous adverse reaction to ketamine or ondansetron, parent, guardian or patient unwilling to provide informed consent.
Contacts and Locations
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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): NCT00387556


Locations
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United States, Colorado
The Childrens Hospital
Denver, Colorado, United States, 80218
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Joe E Wathen, MD University of Colorado Health Science Center
More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00387556    
Other Study ID Numbers: 02-0528
First Posted: October 13, 2006    Key Record Dates
Last Update Posted: May 13, 2013
Last Verified: May 2013
Keywords provided by University of Colorado, Denver:
ketamine
children
emesis
Additional relevant MeSH terms:
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Vomiting
Signs and Symptoms, Digestive
Ondansetron
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