Overview

Intranasal Ketamine for Procedural Sedation in Pediatric Laceration Repair

Status:
Completed
Trial end date:
2010-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Rhode Island Hospital
Treatments:
Ketamine
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