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

NCT03781817 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: IRB-300002731
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

procedural sedation; ketamine; pediatric; fracture; intranasal; intravenous; emergency department

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Percentage of Participants With Non-serious Adverse Events.

  From induction to discharge from the emergency department.

• Duration of Sedation Using Modified Ramsay Sedation Scale.

  From induction to discharge from sedation by the emergency physician.

• Duration of Emergency Department Stay.

  From arrival to emergency department to discharge order entered by emergency physician.

Study Arms (2)

Intravenous ketamine

ACTIVE COMPARATOR

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

Drug: Intravenous Ketamine

Intranasal ketamine

EXPERIMENTAL

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

Drug: Intranasal Ketamine

Interventions

Intravenous Ketamine 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.

Intravenous ketamine

Intranasal Ketamine 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.

Intranasal ketamine

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Wounds and Injuries; Fractures, Closed; Fractures, Bone; Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: James Statler, MD
• Organization: University of Alabama at Birmingham, Department of Pediatrics

jstatler@uabmc.edu

(205) 638-6048

Study Officials

• James Statler, MD

  Emory University

  STUDY CHAIR

• Judson Barber, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Emergency Medicine Fellow

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: December 20, 2018
• Study Start: September 9, 2019
• Primary Completion: January 21, 2022
• Study Completion: April 30, 2022
• Last Updated: April 20, 2023
• Results First Posted: April 20, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)