Status:
COMPLETED
Intranasal Ketamine for Procedural Sedation in Pediatric Laceration Repair
Lead Sponsor:
Rhode Island Hospital
Conditions:
Laceration
Eligibility:
All Genders
1-7 years
Phase:
PHASE2
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 intraven...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2010
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00451724
Start Date
May 1 2007
End Date
February 1 2010
Last Update
July 22 2010
Active Locations (1)
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1
Hasbro Children's Hospital
Providence, Rhode Island, United States, 02903