Ketamine Versus Etomidate for Procedural Sedation for Pediatric Orthopedic Reductions
Information source: Drexel University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Conscious Sedation Failure During Procedure
Intervention: ketamine and midazolam (Drug); etomidate, fentanyl, and lidocaine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Drexel University College of Medicine Official(s) and/or principal investigator(s): Jannet J Lee-Jayaram, M.D., Principal Investigator, Affiliation: Drexel University College of Medicine
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.
Clinical Details
Official title: Ketamine Versus Etomidate for Procedural Sedation for Pediatric Orthopedic Reductions
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: OSBD-r
Secondary outcome: Likert satisfaction scaleprocedural recall
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.
Eligibility
Minimum age: 5 Years.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
St. Christopher's Hospital for Children, Philadelphia, Pennsylvania 19134, United States
Additional Information
Related publications: Bahn EL, Holt KR. Procedural sedation and analgesia: a review and new concepts. Emerg Med Clin North Am. 2005 May;23(2):503-17. Review. Kennedy RM, Porter FL, Miller JP, Jaffe DM. Comparison of fentanyl/midazolam with ketamine/midazolam for pediatric orthopedic emergencies. Pediatrics. 1998 Oct;102(4 Pt 1):956-63. Acworth JP, Purdie D, Clark RC. Intravenous ketamine plus midazolam is superior to intranasal midazolam for emergency paediatric procedural sedation. Emerg Med J. 2001 Jan;18(1):39-45. Gerardi MJ, Sacchetti AD, Cantor RM, Santamaria JP, Gausche M, Lucid W, Foltin GL. Rapid-sequence intubation of the pediatric patient. Pediatric Emergency Medicine Committee of the American College of Emergency Physicians. Ann Emerg Med. 1996 Jul;28(1):55-74. Review. Ruth WJ, Burton JH, Bock AJ. Intravenous etomidate for procedural sedation in emergency department patients. Acad Emerg Med. 2001 Jan;8(1):13-8. Vinson DR, Bradbury DR. Etomidate for procedural sedation in emergency medicine. Ann Emerg Med. 2002 Jun;39(6):592-8. Dickinson R, Singer AJ, Carrion W. Etomidate for pediatric sedation prior to fracture reduction. Acad Emerg Med. 2001 Jan;8(1):74-7. Schenarts CL, Burton JH, Riker RR. Adrenocortical dysfunction following etomidate induction in emergency department patients. Acad Emerg Med. 2001 Jan;8(1):1-7. Godambe SA, Elliot V, Matheny D, Pershad J. Comparison of propofol/fentanyl versus ketamine/midazolam for brief orthopedic procedural sedation in a pediatric emergency department. Pediatrics. 2003 Jul;112(1 Pt 1):116-23. Scott J, Huskisson EC. Graphic representation of pain. Pain. 1976 Jun;2(2):175-84. Keim SM, Erstad BL, Sakles JC, Davis V. Etomidate for procedural sedation in the emergency department. Pharmacotherapy. 2002 May;22(5):586-92. Mace SE, Barata IA, Cravero JP, Dalsey WC, Godwin SA, Kennedy RM, Malley KC, Moss RL, Sacchetti AD, Warden CR, Wears RL; American College of Emergency Physicians. Clinical policy: evidence-based approach to pharmacologic agents used in pediatric sedation and analgesia in the emergency department. Ann Emerg Med. 2004 Oct;44(4):342-77. Jay SM, Ozolins M, Elliott C, Caldwell S. Assessment of children's distress during painful medical procedures. J Health Psycho. 1983; 2: 133-147
Starting date: August 2006
Last updated: August 13, 2014
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