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