CClinicalTrials.gg
Status unknownNCT01477242Updated Jan 20, 2012

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

An interventional study of Ondansetron in Sedation and Analgesia and Side Effect of Drug, sponsored by Seoul National University Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 3 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-01-20.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
266
Allocation
Randomized
Ages
3 Months and older
Sex
All
01

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.

Read the 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
02

Conditions studied

  • Sedation and Analgesia
  • Side Effect of Drug

Keywords

  • vomiting
  • anti-emetics
  • ketamine
  • sedation
03

In context

Drug-Related Side Effects and Adverse Reactions

437 studies on the registry are indexed under Drug-Related Side Effects and Adverse Reactions; 76 are open to participants now.

This study's planned enrollment of 266 is above the median of 103 across 255 interventional studies indexed under Drug-Related Side Effects and Adverse Reactions.

Browse Drug-Related Side Effects and Adverse Reactions studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Months and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
266 participants (estimated)

Study arms

  • Experimental
    Ondansetron

    Ondansetron use group

    Drug: Ondansetron

  • Placebo comparator
    Placebo

    Placebo group

    Drug: Ondansetron

Interventions

  • DrugOndansetron

    2mg (5mL) in \< 15 kg and 4mg (10mL) in 15kg to 30kg

    Also known as: Zofran zydis, vomiset

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

1 of 1 sites recruiting
  • Seoul National University Hospital
    Seoul, 110744, Korea, Republic of
    • Do Kyun Kim, M.D. · Contact · 82-2-2072-0238
    • Do Kyun Kim, M.D. · Principal investigator
    • Jae Yun Jung, M.D. · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01477242
Lead sponsor
Seoul National University Hospital
Collaborators
Asan Medical Center, Myongji Hospital
Responsible party
Do Kyun Kim (assistant professor, Seoul National University Hospital) — Principal investigator
First posted
Nov 22, 2011
Start date
Nov 2011
Primary completion
May 2012 (estimated)
Completion
May 2012 (estimated)
Last update
Jan 20, 2012

Study contacts

Do Kyun Kim, M.D.
Contact
birdbeak@naver.com
82-2-2072-0238
Do Kyun Kim, M.D.
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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