Trauma Clinical Trial
Official title:
Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures
Verified date | April 2023 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This a randomized clinical trial involving children with non-operative fractures presenting the emergency department randomized either to intranasal or intravenous ketamine.
Status | Terminated |
Enrollment | 40 |
Est. completion date | April 30, 2022 |
Est. primary completion date | January 21, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 18 Years |
Eligibility | Inclusion Criteria: - Children 1-18 years of age. - American Society of Anesthesiologists (ASA) I or II - Non-operative fracture requiring reduction - Body weight less than or equal to 25 kg as measured by standard weighing scale Exclusion Criteria: - ASA classification III or above - Age less than 1 year - History of hypertension, known coronary artery disease or Kawasaki disease, congestive heart failure, acute glaucoma or globe injury, increased intracranial pressure or intracranial mass lesion, acute porphyria, developmental delays, or major psychiatric disorder - Prior allergy to ketamine - Unavailable parent or guardian to provide consent - Non-English speaking |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama at Birmingham | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants Who Achieved Adequate Sedation. | Determine if IN ketamine provides non-inferior sedation to IV ketamine as defined by a Modified Ramsay Sedation score of = 4. Modified Ramsay Sedation scale is used to evaluate levels of sedation. The scale range is from 0 to 6 with a higher score indicated deeper levels of sedation. At levels of 4 or greater is set to be satisfactory for deep sedation. | Induction up to 10 minutes | |
Primary | Percentage of Adequately Sedated Participants Successfully Completing the Procedure Without Requiring Rescue Medications. | Rescue medication is defined as requiring additional doses of Ketamine to maintain adequate sedation. Successful procedure completion will be define as completing the procedure with only the induction dose and without requiring rescue medications. | From induction to discharge from sedation by emergency physician, up to 3 hours. | |
Secondary | Percentage of Participants With Non-serious Adverse Events. | Non-serious adverse events include allergic reaction, vomiting, emergence agitation, and oxygen desaturations. | From induction to discharge from the emergency department. | |
Secondary | Duration of Sedation Using Modified Ramsay Sedation Scale. | Modified Ramsay Sedation scale is used to evaluate levels of sedation. The scale range is from 0 to 6 with a higher score indicated deeper levels of sedation. At levels of 2 or less is set to be satisfactory for discharge from sedation. | From induction to discharge from sedation by the emergency physician. | |
Secondary | Duration of Emergency Department Stay. | Measured from time of arrival to emergency department to discharge order. | From arrival to emergency department to discharge order entered by emergency physician. |
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