Ketamine Versus Etomidate for Procedural Sedation for Pediatric Orthopedic Reductions
NCT ID: NCT00596050
Last Updated: 2017-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
50 participants
INTERVENTIONAL
2006-08-31
2008-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ketamine and midazolam
ketamine and midazolam
ketamine and midazolam
ketamine 1 mg/kg/dose, midazolam 0.05 mg/kg/dose max 2 mg
etomidate and fentanyl and lidocaine
etomidate and fentanyl and lidocaine
etomidate, fentanyl, and lidocaine
etomidate 0.2 mg/kg/dose, fentanyl 1 microgram/kg/dose, lidocaine 0.5 mg/kg/dose
Interventions
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ketamine and midazolam
ketamine 1 mg/kg/dose, midazolam 0.05 mg/kg/dose max 2 mg
etomidate, fentanyl, and lidocaine
etomidate 0.2 mg/kg/dose, fentanyl 1 microgram/kg/dose, lidocaine 0.5 mg/kg/dose
Eligibility Criteria
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Inclusion Criteria
* extremity fracture requiring reduction with sedation in emergency department
Exclusion Criteria
* multi-system trauma
* history of psychosis
* pregnancy
* illicit drug use
* developmental delay
* non-english speaker
5 Years
18 Years
ALL
Yes
Sponsors
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Drexel University College of Medicine
OTHER
Responsible Party
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Principal Investigators
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Jannet J Lee-Jayaram, M.D.
Role: PRINCIPAL_INVESTIGATOR
Drexel University College of Medicine
Locations
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St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States
Countries
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References
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Bahn EL, Holt KR. Procedural sedation and analgesia: a review and new concepts. Emerg Med Clin North Am. 2005 May;23(2):503-17. doi: 10.1016/j.emc.2004.12.013.
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. doi: 10.1542/peds.102.4.956.
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. doi: 10.1136/emj.18.1.39.
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. doi: 10.1016/s0196-0644(96)70140-3.
Ruth WJ, Burton JH, Bock AJ. Intravenous etomidate for procedural sedation in emergency department patients. Acad Emerg Med. 2001 Jan;8(1):13-8. doi: 10.1111/j.1553-2712.2001.tb00539.x.
Vinson DR, Bradbury DR. Etomidate for procedural sedation in emergency medicine. Ann Emerg Med. 2002 Jun;39(6):592-8. doi: 10.1067/mem.2002.123695.
Dickinson R, Singer AJ, Carrion W. Etomidate for pediatric sedation prior to fracture reduction. Acad Emerg Med. 2001 Jan;8(1):74-7. doi: 10.1111/j.1553-2712.2001.tb00558.x.
Schenarts CL, Burton JH, Riker RR. Adrenocortical dysfunction following etomidate induction in emergency department patients. Acad Emerg Med. 2001 Jan;8(1):1-7. doi: 10.1111/j.1553-2712.2001.tb00537.x.
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. doi: 10.1542/peds.112.1.116.
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. doi: 10.1592/phco.22.8.586.33204.
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. doi: 10.1016/j.annemergmed.2004.04.012. 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
Other Identifiers
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Project No 1041266
Identifier Type: OTHER
Identifier Source: secondary_id
Action No 47488
Identifier Type: OTHER
Identifier Source: secondary_id
Detail No 240976
Identifier Type: OTHER
Identifier Source: secondary_id
16271
Identifier Type: -
Identifier Source: org_study_id
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