Ketamine Versus Etomidate for Procedural Sedation for Pediatric Orthopedic Reductions - Full Text View

Purpose

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.

Condition	Intervention	Phase
Procedural Sedation	Drug: ketamine and midazolam Drug: etomidate, fentanyl, lidocaine	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Ketamine Versus Etomidate for Procedural Sedation for Pediatric Orthopedic Reductions

Resource links provided by NLM:

MedlinePlus related topics: Fractures

Drug Information available for: Lidocaine hydrochloride Lidocaine Fentanyl Fentanyl citrate Ketamine hydrochloride Ketamine Etomidate Midazolam hydrochloride

U.S. FDA Resources

Further study details as provided by Drexel University:

Primary Outcome Measures:

OSBD-r [ Time Frame: immediate ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Likert satisfaction scale [ Time Frame: immediate ] [ Designated as safety issue: No ]
procedural recall [ Time Frame: immediate ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	August 2006
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 ketamine and midazolam	Drug: ketamine and midazolam ketamine 1 mg/kg/dose, midazolam 0.05 mg/kg/dose max 2 mg
Experimental: 2 etomidate and fentanyl and lidocaine	Drug: etomidate, fentanyl, lidocaine etomidate 0.2 mg/kg/dose, fentanyl 1 microgram/kg/dose, lidocaine 0.5 mg/kg/dose

Eligibility

Ages Eligible for Study:	5 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00596050

Locations

United States, Pennsylvania
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134

Sponsors and Collaborators

Drexel University College of Medicine

Investigators

Principal Investigator:

Jannet J Lee-Jayaram, M.D.

Drexel University College of Medicine

More Information

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

Responsible Party:	Jannet J. Lee-Jayaram, M.D./Clinical Instructor in Pediatrics and Emergency Medicine, Drexel University College of Medicine
ClinicalTrials.gov Identifier:	NCT00596050 History of Changes
Other Study ID Numbers:	16271, Project No 1041266, Action No 47488, Detail No 240976
Study First Received:	January 7, 2008
Last Updated:	March 25, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Drexel University:

procedural sedation
fracture reduction
pediatric emergency medicine

etomidate
ketamine
analgesia

Additional relevant MeSH terms:

Ketamine
Fentanyl
Midazolam
Etomidate
Lidocaine
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Excitatory Amino Acid Antagonists

Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Hypnotics and Sedatives
GABA Modulators
GABA Agents
Narcotics
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 22, 2013