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

Last updated: January 19, 2012
Sponsor: Seoul National University Hospital
Overall Status: Trial Status Unknown

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT01477242
H-1105-114-364
  • Ages > 3
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • don't want to enroll to study

  • children with condition of contraindication of ketamine (IICP, IIOP, psychosis, braintumor, thyroid disease, porphyria)

  • children with condition of contraindication of ondansetron (hypersensitivity to 5-HT3antagonist, 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

Study Design

Total Participants: 266
Study Start date:
November 01, 2011
Estimated Completion Date:
May 31, 2012

Study 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

Connect with a study center

  • Seoul National University Hospital

    Seoul, 110744
    Korea, Republic of

    Active - Recruiting

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