Clinical trial NCT03781817: Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures
Official title: Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Trauma
Fractures, Closed
Children, Only
Deep Sedation
Ketamine
Keywords: procedural sedation
ketamine
pediatric
fracture
intranasal
intravenous
emergency department
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2018-12-20
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This a randomized clinical trial involving children with non-operative fractures presenting the emergency department randomized either to intranasal or intravenous ketamine.

Detailed description: The purpose of this study is to determine if Intranasal Ketamine (INK) is efficacious for Procedural Sedation and Analgesia (PSA) when compared to Intravenous Ketamine (IVK) in children with non-operative fractures. The primary aim is to determine if INK provides non-inferior sedation to IVK as defined by a Modified Ramsay Sedation score of ≥ 4 and also to compare the proportion of successful procedure between two treatment groups. The secondary aim is to compare proportion of adverse events and compare duration of sedation and length of emergency department (ED) stay between treatment groups.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Who Achieved Adequate Sedation.
timeFrame: Induction up to 10 minutes
measure: Percentage of Adequately Sedated Participants Successfully Completing the Procedure Without Requiring Rescue Medications.
timeFrame: From induction to discharge from sedation by emergency physician, up to 3 hours.
Secondary outcomes:
measure: Percentage of Participants With Non-serious Adverse Events.
timeFrame: From induction to discharge from the emergency department.
measure: Duration of Sedation Using Modified Ramsay Sedation Scale.
timeFrame: From induction to discharge from sedation by the emergency physician.
measure: Duration of Emergency Department Stay.
timeFrame: From arrival to emergency department to discharge order entered by emergency physician.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: Emory University
name: James Statler, MD
role: STUDY_CHAIR
affiliation: University of Alabama at Birmingham
name: Judson Barber, MD
role: PRINCIPAL_INVESTIGATOR
References: