Intranasal Ketamine for Procedural Sedation in Pediatric Laceration Repair
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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 |
- Efficacy of sedation (OSBDR) [ Time Frame: 30 minutes ]
- Time to onset of sedation (Ramsay 6-point Sedation Scale) [ Time Frame: 30 minutes ]
- 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 |
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 |
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| United States, Rhode Island | |
| Hasbro Children's Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| 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 June 13, 2013