Intranasal Ketamine for Procedural Sedation in Pediatric Laceration Repair

NCT ID: NCT00451724

Last Updated: 2010-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2010-02-28

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 intravenous line to give intravenous medications can be as distressing as the procedure itself. Oral medications generally take longer to work and are subject to first-pass metabolism. Another alternative is to give the medication by the intranasal route, which only requires a spray into the nose. Ketamine is a good sedative drug with favorable qualities, and is often used intramuscularly or intravenously. It has been used intranasally as a pre-induction by anesthetics, sedation for CT scans, and brief dental procedures, but its use has not yet been demonstrated in the setting of the pediatric emergency department for procedural sedation. We will be comparing three different doses of ketamine, applied intranasally using a mucosal atomization device, and determining if there are any differences in efficacy of sedation, time to onset of sedation, duration of sedation, caregiver and physician satisfaction, and number of adverse events. We will also use this opportunity to determine ketamine bioavailability when given intranasally using the mucosal atomization device.

Conditions

Laceration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Intranasal ketamine

Intervention Type: DRUG

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rhode Island Hospital

OTHER

Sponsor Role: lead

Principal Investigators

James G Linakis, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital

Locations

Hasbro Children's Hospital

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

0014-07

Identifier Type: -

Identifier Source: org_study_id