Ketamine Versus Etomidate for Procedural Sedation for Pediatric Orthopedic Reductions

Drexel University

Status and phase: Completed; Phase 4

Conditions: Conscious Sedation Failure During Procedure

Treatments: Drug: etomidate, fentanyl, and lidocaine; Drug: ketamine and midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT00596050

Detail No 240976 (Other Identifier)

16271

Project No 1041266 (Other Identifier)

Action No 47488 (Other Identifier)

Details and patient eligibility

About

There are multiple retrospective studies detailing the use of etomidate in pediatric procedural sedation but few to no prospective clinical trials. None have compared etomidate to ketamine, currently the most commonly used sedative in the emergency department for pediatric procedural sedation. The investigators propose a randomized, controlled trial comparing etomidate versus ketamine for procedural sedation for fracture reduction for children presenting with extremity fracture requiring sedation for reduction. The investigators hypothesize that etomidate in combination with fentanyl will have similar reduction of distress and procedural recall as ketamine in combination with midazolam.

Full description

There are multiple retrospective studies detailing the use of etomidate in pediatric procedural sedation but few to no prospective clinical trials. None have compared etomidate to ketamine, currently the most commonly used sedative in the emergency department for pediatric procedural sedation. The investigators propose a randomized, controlled trial comparing etomidate versus ketamine for procedural sedation for fracture reduction for children presenting with extremity fracture requiring sedation for reduction. The investigators hypothesize that etomidate in combination with fentanyl will have similar reduction of distress and procedural recall as ketamine in combination with midazolam.

Enrollment: 50 patients

Sex: All

Ages: 5 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age 5-18 years
• extremity fracture requiring reduction with sedation in emergency department

Exclusion criteria

• allergy to etomidate, midazolam, fentanyl, ketamine, lidocaine
• multi-system trauma
• history of psychosis
• pregnancy
• illicit drug use
• developmental delay
• non-english speaker

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

50 participants in 2 patient groups

ketamine and midazolam

Active Comparator group

Description:

ketamine and midazolam

Treatment:

Drug: ketamine and midazolam

etomidate and fentanyl and lidocaine

Active Comparator group

Description:

etomidate and fentanyl and lidocaine

Treatment:

Drug: etomidate, fentanyl, and lidocaine