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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

Tracking Information
First Submitted Date  ICMJE October 23, 2011
First Posted Date  ICMJE November 22, 2011
Last Update Posted Date January 20, 2012
Study Start Date  ICMJE November 2011
Estimated Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2011)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2011)
  • parent's satisfaction [ Time Frame: satisfaction will be surveyed within 48hours after discharge ]
  • length of emergency department stay [ Time Frame: length of stay will be calculated upto 24 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Ondansetron During Intramuscular Ketamine Use in Children: A Trial in Emergency Department
Official Title  ICMJE The Effect of Oral Ondansetron During Intramuscular Ketamine Use in Children
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Sedation and Analgesia
  • Side Effect of Drug
Intervention  ICMJE Drug: Ondansetron
2mg (5mL) in < 15 kg and 4mg (10mL) in 15kg to 30kg
Other Names:
  • Zofran zydis
  • vomiset
Study Arms  ICMJE
  • Experimental: Ondansetron
    Ondansetron use group
    Intervention: Drug: Ondansetron
  • Placebo Comparator: Placebo
    Placebo group
    Intervention: Drug: Ondansetron
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 18, 2011)
266
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2012
Estimated Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Months and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01477242
Other Study ID Numbers  ICMJE H-1105-114-364
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Do Kyun Kim, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE
  • Asan Medical Center
  • Myongji Hospital
Investigators  ICMJE
Principal Investigator: Do Kyun Kim, M.D. Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP