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

Study Overview
=================
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

Official Title
-----------------
The Effect of Oral Ondansetron During Intramuscular Ketamine Use in Children

Conditions
-----------------
Sedation and Analgesia, Side Effect of Drug

Intervention / Treatment
-----------------
* Drug: Ondansetron


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 3 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ondansetron<br>Ondansetron use group | Drug: Ondansetron<br>* 2mg (5mL) in < 15 kg and 4mg (10mL) in 15kg to 30kg<br>* Other names: vomiset;|
| Placebo Comparator: Placebo<br>Placebo group | Drug: Ondansetron<br>* 2mg (5mL) in < 15 kg and 4mg (10mL) in 15kg to 30kg<br>* Other names: vomiset;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vomiting, anti-emetics, ketamine, sedation