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Ketamine Versus Etomidate for Procedural Sedation for Pediatric Orthopedic Reductions

Information source: Drexel University
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Procedural Sedation

Intervention: ketamine and midazolam (Drug); etomidate, fentanyl, lidocaine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Drexel University

Official(s) and/or principal investigator(s):
Jannet J Lee-Jayaram, M.D., Principal Investigator, Affiliation: Drexel University College of Medicine

Overall contact:
Jannet J Lee-Jayaram, M.D., Phone: 215-427-8431, Email: jjl48@drexel.edu

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. We 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. We 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, Control: Active Control, 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 scale

procedural recall

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

Jannet J Lee-Jayaram, M.D., Phone: 215-427-8431, Email: jjl48@drexel.edu

St. Christopher's Hospital for Children, Philadelphia, Pennsylvania 19134, United States; Recruiting
Jannet J Lee-Jayaram, M.D., Principal Investigator
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. No abstract available.

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. No abstract available.

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: January 15, 2008

Page last updated: October 04, 2010

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