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

The University of Alabama at Birmingham

Status and phase: Terminated; Phase 4

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

Treatments: Drug: Intravenous Ketamine; Drug: Intranasal Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT03781817

IRB-300002731

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Intravenous ketamine

Active Comparator group

Description:

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

Treatment:

Drug: Intravenous Ketamine

Intranasal ketamine

Experimental group

Description:

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

Treatment:

Drug: Intranasal Ketamine