Ondansetron Reduce Vomiting Associated With Ketamine PSA

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Conscious Sedation

Treatments: Drug: Ondansetron

Study type: Interventional

Funder types: Other

Identifiers

NCT00387556

02-0528

Details and patient eligibility

About

Ondansetron, a commonly used anti-vomiting medication, may reduce the occurrence of vomiting associated with ketamine during procedural sedation in the pediatric emergency department.

Enrollment: 268 patients

Sex: All

Ages: 1 to 21 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age 1-21 years, ASA I or II, fracture of dislocation reduction

Exclusion criteria

• age < 1 year, ASA III or IV, hypertension, glaucoma, acute globe injury, increased intracranial pressure or central nervous system mass lesion, major psychiatric disorder, porphyria, previous adverse reaction to ketamine or ondansetron, parent, guardian or patient unwilling to provide informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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268 participants in 2 patient groups, including a placebo group

Ketamine + Ondansetron

Experimental group

Description:

ketamine 1 mg/kg IV (maximum single dose 100 mg)+ondansetron (0.15 mg/kg/dose; maximum dose 4 mg)

Treatment:

Drug: Ondansetron

Ketamine + Placebo

Placebo Comparator group

Description:

ketamine 1 mg/kg IV (maximum single dose 100 mg)+2 ml normal saline solution IV (placebo

Treatment:

Drug: Ondansetron