Intranasal Ketamine for Procedural Sedation in Pediatric Laceration Repair

Laceration Clinical Trial

Official title:

Intranasal Ketamine for Procedural Sedation in Pediatric Laceration Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00451724
• Other study ID #: 0014-07
• Status: Completed
• Phase: Phase 2
• First received: March 21, 2007
• Last updated: July 21, 2010
• Start date: May 2007
• Est. completion date: February 2010

Study information

• Verified date: July 2010
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 7 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Laceration
• Lacerations

Intervention

Drug:
• Intranasal ketamine

Locations

Country	Name	City	State
United States	Hasbro Children's Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Rhode Island Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of sedation (OSBDR)		30 minutes
Primary	Time to onset of sedation (Ramsay 6-point Sedation Scale)		30 minutes
Secondary	Duration of sedation		Up to 1 hour
Secondary	Primary caregiver satisfaction		24 hours
Secondary	Physician satisfaction		Duration of procedure
Secondary	Ketamine bioavailability		1 hour
Secondary	Abnormalities in cardiopulmonary function		Until time of discharge
Secondary	Administration of supplemental sedative medication		During time required for procedure
Secondary	Prolonged sedation (i.e. > 1 hour)		Until time of discharge from emergency department