CompletedPhase 2ketamine

Intranasal Ketamine for Procedural Sedation in Pediatric Laceration Repair

NCT ID

NCT00451724

Target Enrollment

45 participants

Start Date

2007-05

Est. Completion

2010-02

About This Study

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.

Conditions Studied

Laceration

Interventions

•Intranasal ketamine

Eligibility

Age:1 Year - 7 Years

Healthy Volunteers:Yes

View full eligibility 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

Study Locations (1)

Hasbro Children's Hospital

Providence, Rhode Island, United States