Laceration
Conditions
Keywords
Prospective, Randomized, Double blinded, Sedation, Ketamine, Intranasal
Brief summary
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
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.
Interventions
DRUGIntranasal ketamine
Sponsors
Rhode Island Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
1 Years to 7 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of sedation (OSBDR) | 30 minutes |
| Time to onset of sedation (Ramsay 6-point Sedation Scale) | 30 minutes |
Secondary
| Measure | Time frame |
|---|---|
| Physician satisfaction | Duration of procedure |
| Ketamine bioavailability | 1 hour |
| Duration of sedation | Up to 1 hour |
| Administration of supplemental sedative medication | During time required for procedure |
| Prolonged sedation (i.e. > 1 hour) | Until time of discharge from emergency department |
| Abnormalities in cardiopulmonary function | Until time of discharge |
| Primary caregiver satisfaction | 24 hours |
Countries
United States
Outcome results
None listed