Clinical trial NCT00451724: Intranasal Ketamine for Procedural Sedation in Pediatric Laceration Repair
Official title: Intranasal Ketamine for Procedural Sedation in Pediatric Laceration Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Laceration
Keywords: Prospective
Randomized
Double blinded
Sedation
Ketamine
Intranasal
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2007-03-23
Enrollment: 45
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy of sedation (OSBDR)
timeFrame: 30 minutes
measure: Time to onset of sedation (Ramsay 6-point Sedation Scale)
timeFrame: 30 minutes
Secondary outcomes:
measure: Duration of sedation
timeFrame: Up to 1 hour
measure: Primary caregiver satisfaction
timeFrame: 24 hours
measure: Physician satisfaction
timeFrame: Duration of procedure
measure: Ketamine bioavailability
timeFrame: 1 hour
measure: Abnormalities in cardiopulmonary function
timeFrame: Until time of discharge
measure: Administration of supplemental sedative medication
timeFrame: During time required for procedure
measure: Prolonged sedation (i.e. > 1 hour)
timeFrame: Until time of discharge from emergency department
Other outcomes:
Locations:
city: Providence
country: United States
facility: Hasbro Children's Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: James G Linakis, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: