Intranasal Ketamine for Procedural Sedation in Pediatric Laceration Repair

Completed · Phase 2

Conditions studied: Laceration

In brief

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.

Key facts

Study ID

NCT00451724

Run by

Rhode Island Hospital

People needed

45

Starts

2007-05-01

Expected to finish

2010-02-01

Last updated by the study team

2010-07-22

Who can join

Age: 1 and older, up to 7. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hasbro Children's Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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