Intranasal Ketamine for Procedural Sedation in Pediatric Laceration Repair

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.

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

Study Locations

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

Participation Criteria

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

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)	30 minutes
Time to onset of sedation (Ramsay 6-point Sedation Scale)	30 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

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: March 21, 2007
• First Posted (Estimate): March 23, 2007

Study Record Updates

• Last Update Posted (Estimate): July 22, 2010
• Last Update Submitted That Met QC Criteria: July 21, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: Ketamine; Randomized; Sedation; Intranasal; Prospective; Double blinded
• Additional Relevant MeSH Terms: Wounds and Injuries; Lacerations; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: 0014-07