Intranasal Ketamine for Procedural Sedation in Pediatric Laceration Repair

Study Overview
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Brief Summary
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The purpose of this study is to compare how well three different doses of ketamine, given as a spray into the nose, help to sedate children and help them tolerate repairs of cuts on their faces.

Detailed Description
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Procedural sedation is frequently used to facilitate distressing and painful procedures in the pediatric emergency department. However, administering an intramuscular medication or placing an intravenous line to give intravenous medications can be as distressing as the procedure itself. Oral medications generally take longer to work and are subject to first-pass metabolism. Another alternative is to give the medication by the intranasal route, which only requires a spray into the nose. Ketamine is a good sedative drug with favorable qualities, and is often used intramuscularly or intravenously. It has been used intranasally as a pre-induction by anesthetics, sedation for CT scans, and brief dental procedures, but its use has not yet been demonstrated in the setting of the pediatric emergency department for procedural sedation. We will be comparing three different doses of ketamine, applied intranasally using a mucosal atomization device, and determining if there are any differences in efficacy of sedation, time to onset of sedation, duration of sedation, caregiver and physician satisfaction, and number of adverse events. We will also use this opportunity to determine ketamine bioavailability when given intranasally using the mucosal atomization device.

Official Title
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Intranasal Ketamine for Procedural Sedation in Pediatric Laceration Repair

Conditions
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Laceration

Intervention / Treatment
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* Drug: Intranasal ketamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children between 1 to 7 years old Simple facial laceration, defined as: linear; requiring two or more sutures; no greater than 5.0 centimeters; does not cross the lid margin of the eye; does not require a plastics/face surgery consult; occured within the last 24 hours. Physician feels that intravenous sedation is required to perform the laceration repair Exclusion Criteria: Closed head injury, any alteration in level of consciousness, clinical suspicion of intracranial injury or increased intracranial pressure Any conditions that qualify patient as American Society of Anesthesiologists' (ASA) III or IV Known diagnoses of hyperthyroidism or porphyria Glaucoma or penetrating eye injury Hypertension Any contraindication, including drug allergy, to study medications Severe trauma with other injuries requiring operative intervention Abnormal neurological exam in a previously normal child

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Intranasal ketamine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of sedation (OSBDR) |  | 30 minutes | 
| Time to onset of sedation (Ramsay 6-point Sedation Scale) |  | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of sedation |  | Up to 1 hour | 
| Primary caregiver satisfaction |  | 24 hours | 
| Physician satisfaction |  | Duration of procedure | 
| Ketamine bioavailability |  | 1 hour | 
| Abnormalities in cardiopulmonary function |  | Until time of discharge | 
| Administration of supplemental sedative medication |  | During time required for procedure | 
| Prolonged sedation (i.e. > 1 hour) |  | Until time of discharge from emergency department | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prospective, Randomized, Double blinded, Sedation, Ketamine, Intranasal