Intranasal ketamine in Laceration - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Laceration

Intervention / Treatment

Drug: Intranasal ketamine

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.

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Rhode Island
  - Providence, Rhode Island, United States, 02903
    - Hasbro Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 7 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy of sedation (OSBDR) Time Frame: 30 minutes	30 minutes
Time to onset of sedation (Ramsay 6-point Sedation Scale) Time Frame: 30 minutes	30 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Duration of sedation Time Frame: Up to 1 hour	Up to 1 hour
Primary caregiver satisfaction Time Frame: 24 hours	24 hours
Physician satisfaction Time Frame: Duration of procedure	Duration of procedure
Ketamine bioavailability Time Frame: 1 hour	1 hour
Abnormalities in cardiopulmonary function Time Frame: Until time of discharge	Until time of discharge
Administration of supplemental sedative medication Time Frame: During time required for procedure	During time required for procedure
Prolonged sedation (i.e. > 1 hour) Time Frame: Until time of discharge from emergency department	Until time of discharge from emergency department

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rhode Island Hospital

Investigators

Principal Investigator: James G Linakis, PhD, MD, Rhode Island Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

March 21, 2007

First Submitted That Met QC Criteria