Intranasal Ketamine for Procedural Sedation in Pediatric Laceration Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00451724
Recruitment Status : Completed
First Posted : March 23, 2007
Last Update Posted : July 22, 2010
Information provided by:
Rhode Island Hospital

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.

Condition or disease Intervention/treatment Phase
Laceration Drug: Intranasal ketamine Phase 2

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  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Intranasal Ketamine for Procedural Sedation in Pediatric Laceration Repair
Study Start Date : May 2007
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
Drug Information available for: Ketamine

Primary Outcome Measures :
  1. Efficacy of sedation (OSBDR) [ Time Frame: 30 minutes ]
  2. Time to onset of sedation (Ramsay 6-point Sedation Scale) [ Time Frame: 30 minutes ]

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

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Ages Eligible for Study:   1 Year to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00451724

United States, Rhode Island
Hasbro Children's Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Rhode Island Hospital
Principal Investigator: James G Linakis, PhD, MD Rhode Island Hospital Identifier: NCT00451724     History of Changes
Other Study ID Numbers: 0014-07
First Posted: March 23, 2007    Key Record Dates
Last Update Posted: July 22, 2010
Last Verified: July 2010

Keywords provided by Rhode Island Hospital:
Double blinded

Additional relevant MeSH terms:
Wounds and Injuries
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action