Intranasal Ketamine for Procedural Sedation in Pediatric Laceration Repair

This study has been completed.
Sponsor:
Information provided by:
Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT00451724
First received: March 21, 2007
Last updated: July 21, 2010
Last verified: July 2010
  Purpose

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 Intervention Phase
Laceration
Drug: Intranasal ketamine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Intranasal Ketamine for Procedural Sedation in Pediatric Laceration Repair

Resource links provided by NLM:


Further study details as provided by Rhode Island Hospital:

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

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

Estimated Enrollment: 45
Study Start Date: May 2007
Study Completion Date: February 2010
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.

  Eligibility

Ages Eligible for Study:   1 Year to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00451724

Locations
United States, Rhode Island
Hasbro Children's Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Rhode Island Hospital
Investigators
Principal Investigator: James G Linakis, PhD, MD Rhode Island Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00451724     History of Changes
Other Study ID Numbers: 0014-07
Study First Received: March 21, 2007
Last Updated: July 21, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Rhode Island Hospital:
Prospective
Randomized
Double blinded
Sedation
Ketamine
Intranasal

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

ClinicalTrials.gov processed this record on April 23, 2014