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The Effect of Ondansetron During Intramuscular Ketamine Use in Children: A Trial in Emergency Department

This study is currently recruiting participants.
Verified January 2012 by Seoul National University Hospital
Sponsor:
Collaborators:
Asan Medical Center
Myongji Hospital
Information provided by (Responsible Party):
Do Kyun Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01477242
First received: October 23, 2011
Last updated: January 19, 2012
Last verified: January 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the anti-emetic effect of oral ondansetron. For this evaluation, the investigators will perform a multi-center, double-blind, placebo-controled, randomized study. The investigators assumption is that oral ondansetron prior to intramuscular ketamine will reduce the occurrence of ketamine-induced vomiting.


Condition Intervention
Sedation and Analgesia
Side Effect of Drug
 Drug: Ondansetron

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Oral Ondansetron During Intramuscular Ketamine Use in Children

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • vomiting at ED stay and 12 hours after discharge [ Time Frame: the participants will be followed for the duration of ED stay (upto 24hr) and 12hours after discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • parent's satisfaction [ Time Frame: satisfaction will be surveyed within 48hours after discharge ] [ Designated as safety issue: No ]
  • length of emergency department stay [ Time Frame: length of stay will be calculated upto 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 266
Study Start Date: November 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ondansetron
Ondansetron use group
 Drug: Ondansetron
2mg (5mL) in < 15 kg and 4mg (10mL) in 15kg to 30kg
Other Names:
  • Zofran zydis
  • vomiset
Placebo Comparator: Placebo
Placebo group
 Drug: Ondansetron
2mg (5mL) in < 15 kg and 4mg (10mL) in 15kg to 30kg
Other Names:
  • Zofran zydis
  • vomiset

Detailed Description:

Methods

  • a multi-center, double-blind, placebo-controled, randomized study ( 4 tertiary hospital ED)
  • survey for the occurrence of vomiting at ED and after discharge

Primary outcome

  • the number of vomiting at ED and at home

Secondary outcome

  • parent's satisfaction and ED length of stay
  Eligibility

Ages Eligible for Study:   3 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • children under 18 years of age
  • children who are planned to admit ketamine intramuscular injection
  • children with ASA classification class I or II

Exclusion Criteria:

  • don't want to enroll to study
  • children with condition of contraindication of ketamine (IICP, IIOP, psychosis, brain tumor, thyroid disease, porphyria)
  • children with condition of contraindication of ondansetron (hypersensitivity to 5-HT3 antagonist, Long QT syndrome, severe liver failure, obstructive ileus)
  • children under 3 months of age
  • children whose weight are over 30 kg
  • children managed by other drug with ketamine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01477242

Contacts
Contact: Do Kyun Kim, M.D. 82-2-2072-0238 birdbeak@naver.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110744
Contact: Do Kyun Kim, M.D.     82-2-2072-0238        
Principal Investigator: Do Kyun Kim, M.D.            
Sub-Investigator: Jae Yun Jung, M.D.            
Sponsors and Collaborators
Seoul National University Hospital
Asan Medical Center
Myongji Hospital
Investigators
Principal Investigator: Do Kyun Kim, M.D. Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Do Kyun Kim, assistant professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01477242     History of Changes
Other Study ID Numbers: H-1105-114-364
Study First Received: October 23, 2011
Last Updated: January 19, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
vomiting
anti-emetics
ketamine
sedation

Additional relevant MeSH terms:
Ketamine
Ondansetron
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Antipsychotic Agents
Tranquilizing Agents
Psychotropic Drugs
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on May 22, 2013