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

NCT01477242 | Unknown

• 1 other identifier: H-1105-114-364
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedation and Analgesia; Side Effect of Drug

Keywords

vomiting; anti-emetics; ketamine; sedation

Outcome Measures

Primary Outcomes (1)

• vomiting at ED stay and 12 hours after discharge

  the participants will be followed for the duration of ED stay (upto 24hr) and 12hours after discharge

Secondary Outcomes (2)

• parent's satisfaction

  satisfaction will be surveyed within 48hours after discharge

• length of emergency department stay

  length of stay will be calculated upto 24 hours

Study Arms (2)

Ondansetron

EXPERIMENTAL

Ondansetron use group

Drug: Ondansetron

Placebo

PLACEBO COMPARATOR

Placebo group

Drug: Ondansetron

Interventions

Ondansetron DRUG

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

Also known as: Zofran zydis, vomiset

Ondansetron; Placebo

Eligibility Criteria

• Age: 3 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Asan Medical Center: collaborator
• Myongji Hospital: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 110744, South Korea

RECRUITING

MeSH Terms

Conditions

Agnosia; Vomiting

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Do Kyun Kim, M.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Do Kyun Kim, M.D.

CONTACT

82-2-2072-0238; birdbeak@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: October 23, 2011
• First Posted: November 22, 2011
• Study Start: November 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: January 20, 2012

Record last verified: 2012-01

Locations

KR (1)