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

• Status: Suspended
• Trial end date: 2022-04-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Treatments: Ketamine

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