Laceration Clinical Trial
Official title:
Intranasal Ketamine for Procedural Sedation in Pediatric Laceration Repair
Verified date | July 2010 |
Source | Rhode Island Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 45 |
Est. completion date | February 2010 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 1 Year to 7 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Hasbro Children's Hospital | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Rhode Island Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy of sedation (OSBDR) | 30 minutes | ||
Primary | Time to onset of sedation (Ramsay 6-point Sedation Scale) | 30 minutes | ||
Secondary | Duration of sedation | Up to 1 hour | ||
Secondary | Primary caregiver satisfaction | 24 hours | ||
Secondary | Physician satisfaction | Duration of procedure | ||
Secondary | Ketamine bioavailability | 1 hour | ||
Secondary | Abnormalities in cardiopulmonary function | Until time of discharge | ||
Secondary | Administration of supplemental sedative medication | During time required for procedure | ||
Secondary | Prolonged sedation (i.e. > 1 hour) | Until time of discharge from emergency department |
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