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

NCT ID: NCT03781817

Last Updated: 2023-04-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-09
• Study Completion Date: 2022-04-30

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.

Conditions

Trauma; Fractures, Closed; Children, Only; Deep Sedation; Ketamine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intravenous ketamine

Participants randomized to IV ketamine will be receive IV ketamine and Intranasal normal saline.

Group Type: ACTIVE_COMPARATOR

Intravenous Ketamine

Intervention Type: DRUG

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

Participants randomized to Intranasal Ketamine group will receive Intranasal ketamine and IV normal saline.

Group Type: EXPERIMENTAL

Intranasal Ketamine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

James Statler

Pediatric Emergency Medicine Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James Statler, MD

Role: STUDY_CHAIR

Emory University

Judson Barber, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

IRB-300002731

Identifier Type: -

Identifier Source: org_study_id