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

Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03781817
• Other study ID #: IRB-300002731
• Status: Terminated
• Phase: Phase 4
• Start date: September 9, 2019
• Est. completion date: April 30, 2022

Study information

• Verified date: April 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Children, Only
• Deep Sedation
• Fractures, Bone
• Fractures, Closed
• Ketamine
• Trauma

Intervention

Drug:
• Intravenous Ketamine
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 Ketamine
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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

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.