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

Phase 4

Terminated

• Conditions: Trauma; Fractures, Closed; Children, Only; Deep Sedation; Ketamine
• Interventions: Drug: Intranasal Ketamine; Drug: Intravenous Ketamine

• Registration Number: NCT03781817
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study First Submitted: 2018-12-18
• Study First Submitted QC: 2018-12-18
• Study First Posted: 2018-12-20
• Study Start: 2019-09-09
• Primary Completion: 2022-01-21
• Study Completion: 2022-04-30
• Results First Submitted: 2023-01-18
• Status Verified: 2023-04
• Results First Submitted QC: 2023-04-19
• Last Update Submitted: 2023-04-19
• Results First Posted: 2023-04-20
• Last Update Posted: 2023-04-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intranasal ketamine	Intranasal Ketamine	Participants randomized to Intranasal Ketamine group will receive Intranasal ketamine and IV normal saline.
Intravenous ketamine	Intravenous Ketamine	Participants randomized to IV ketamine will be receive IV ketamine and Intranasal normal saline.

Primary Outcome Measures

Name	Time	Method
Percentage of Adequately Sedated Participants Successfully Completing the Procedure Without Requiring Rescue Medications.	From induction to discharge from sedation by emergency physician, up to 3 hours.	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.
Number of Participants Who Achieved Adequate Sedation.	Induction up to 10 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Non-serious Adverse Events.	From induction to discharge from the emergency department.	Non-serious adverse events include allergic reaction, vomiting, emergence agitation, and oxygen desaturations.
Duration of Emergency Department Stay.	From arrival to emergency department to discharge order entered by emergency physician.	Measured from time of arrival to emergency department to discharge order.
Duration of Sedation Using Modified Ramsay Sedation Scale.	From induction to discharge from sedation by the emergency physician.	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.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States