Conscious Sedation Failure During Procedure
Conditions
Keywords
procedural sedation, fracture reduction, pediatric emergency medicine, etomidate, ketamine, analgesia
Brief summary
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.
Detailed 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.
Interventions
ketamine 1 mg/kg/dose, midazolam 0.05 mg/kg/dose max 2 mg
DRUGetomidate, fentanyl, and lidocaine
etomidate 0.2 mg/kg/dose, fentanyl 1 microgram/kg/dose, lidocaine 0.5 mg/kg/dose
Sponsors
Drexel University College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OSBD-r | immediate | Outcome measures included guardian and staff completion of visual analog scale and Likert scales for observed pain and satisfaction, blinded OSBD-r (Observational Scale of Behavioral Distress-Revised) scoring of digital recordings of reductions, and sedation and recovery times. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Likert satisfaction scale | immediate | Outcome measures included guardian and staff completion of visual analog scale and Likert scales for observed pain and satisfaction, blinded OSBD-r (Observational Scale of Behavioral Distress-Revised) scoring of digital recordings of reductions, and sedation and recovery times. |
| procedural recall | immediate | Outcome measures included guardian and staff completion of visual analog scale and Likert scales for observed pain and satisfaction, blinded OSBD-r (Observational Scale of Behavioral Distress-Revised) scoring of digital recordings of reductions, and sedation and recovery times. |
Countries
United States
Outcome results
None listed