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

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ClinicalTrials.gov Identifier: NCT01477242
Recruitment Status : Unknown
Verified January 2012 by Do Kyun Kim, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : November 22, 2011
Last Update Posted : January 20, 2012
Sponsor:
Collaborators:
Asan Medical Center
Myongji Hospital
Information provided by (Responsible Party):
Do Kyun Kim, Seoul National University Hospital

Brief Summary:
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 or disease Intervention/treatment
Sedation and Analgesia Side Effect of Drug Drug: Ondansetron

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 266 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Oral Ondansetron During Intramuscular Ketamine Use in Children
Study Start Date : November 2011
Estimated Primary Completion Date : May 2012
Estimated Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. parent's satisfaction [ Time Frame: satisfaction will be surveyed within 48hours after discharge ]
  2. length of emergency department stay [ Time Frame: length of stay will be calculated upto 24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

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): 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

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
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: January 20, 2012
Last Verified: January 2012

Keywords provided by Do Kyun Kim, Seoul National University Hospital:
vomiting
anti-emetics
ketamine
sedation

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Ketamine
Ondansetron
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Antipsychotic Agents
Tranquilizing Agents
Psychotropic Drugs
Anti-Anxiety Agents