Failed Moderate Sedation During Procedure, Ketamine Adverse Reaction
Conditions
Keywords
ketamine, pediatric, procedural sedation
Brief summary
The purpose of this study is to evaluate the feasibility of intranasal ketamine for adequate sedation of children undergoing minor procedures in the Emergency Department. An intranasal dose of 10mg/kg will be used in patients requiring procedural sedation. The investigators hypothesize that this dose of intranasal ketamine will be able to provide adequate sedation and analgesia for the physician to successfully complete the planned diagnostic or therapeutic intervention (Pediatr Emer Care 2012;28: 767-70). The primary endpoint will be successful sedation, as defined by the ability to complete the planned procedure without rescue medication, which includes re-dosing of the same medication.
Interventions
DRUGKetamine Hcl 100Mg/Ml Inj
10mg/kg of Ketamine Hcl 100Mg/Ml Inj to be administered intranasally for pediatric procedural sedation
Sponsors
University of Arizona
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Children who meet inclusion and exclusion criteria will be approached for participation in the study.
Eligibility
Sex/Gender
ALL
Age
2 Years to 7 Years
Healthy volunteers
No
Inclusion criteria
* Children ages 2 years to 7 years who present as patients to the Pediatric Emergency Department at Banner University Medical Center Tucson Campus * Body weight of 20kg or less (actual, estimated, or measured) * NPO for four hours or more * Undergoing various procedures, which are deemed by the treating provider to require procedural sedation for the completion of the procedure.
Exclusion criteria
* Discretion of parents * Discretion of provider * Body weight greater than 20kg (actual, estimated, or measured) * Starting Aldrete score \<9/10 * Known or suspected psychosis * Known or suspected central nervous system mass, abnormalities, hydrocephalus, or other condition that would suggest elevated pre-anesthetic cerebrospinal fluid pressure * Significant elevation in blood pressure * Known hypersensitivity to ketamine * Non-English or Spanish speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful procedural sedation | The patient will be assessed from the start of procedural sedation medication administration until the completion of the procedural sedation, defined as the patient retuning to baseline (alert and oriented x3 with normal behavior). | Successful procedural sedation, as defined by the ability to complete the planned procedure without rescue medication, which includes re-dosing of the same medication. |
Countries
United States
Outcome results
None listed