Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures

Phase 4TerminatedNCT03781817

University of Alabama at Birmingham40 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Trauma Fractures, Closed Children, Only Deep Sedation Ketamine

Interventions

Intravenous KetamineDRUG

Subject randomized to IV Ketamine arm will receive IN Normal Saline at induction. After 8 minutes subjects will receive IV Ketamine (10 mg/mL) at a dose of 1.5 mg/kg. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved.

Intranasal KetamineDRUG

Subject randomized to IN Ketamine arm will receive IN Ketamine (100 mg/mL) at a dose of 9 mg/kg at induction. After 8 minutes subjects will receive IV Normal Saline. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved.

Eligibility

Sex: ALLMin age: 1 YearMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

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.

Time frame: Induction up to 10 minutes

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.

Time frame: From induction to discharge from sedation by emergency physician, up to 3 hours.

Secondary Outcomes

Percentage of Participants With Non-serious Adverse Events.

Non-serious adverse events include allergic reaction, vomiting, emergence agitation, and oxygen desaturations.

Time frame: From induction to discharge from the emergency department.

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.

Time frame: From induction to discharge from sedation by the emergency physician.

Duration of Emergency Department Stay.

Measured from time of arrival to emergency department to discharge order.

Time frame: From arrival to emergency department to discharge order entered by emergency physician.

Data from ClinicalTrials.gov

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