Ketamine Versus Etomidate for Procedural Sedation for Pediatric Orthopedic Reductions

Conscious Sedation Failure During Procedure Clinical Trial

Official title:

Ketamine Versus Etomidate for Procedural Sedation for Pediatric Orthopedic Reductions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00596050
• Other study ID #: 16271
• Secondary ID: Project No 10412
• Status: Completed
• Phase: Phase 4
• First received: January 7, 2008
• Last updated: May 8, 2017
• Start date: August 2006
• Est. completion date: June 2008

Study information

• Verified date: May 2017
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Conscious Sedation Failure During Procedure

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	St. Christopher's Hospital for Children	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Drexel University College of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. — View Citation

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. — View Citation

Dickinson R, Singer AJ, Carrion W. Etomidate for pediatric sedation prior to fracture reduction. Acad Emerg Med. 2001 Jan;8(1):74-7. — View Citation

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. — View Citation

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. — View Citation

Jay SM, Ozolins M, Elliott C, Caldwell S. Assessment of children's distress during painful medical procedures. J Health Psycho. 1983; 2: 133-147

Keim SM, Erstad BL, Sakles JC, Davis V. Etomidate for procedural sedation in the emergency department. Pharmacotherapy. 2002 May;22(5):586-92. — View Citation

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. — View Citation

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. — View Citation

Ruth WJ, Burton JH, Bock AJ. Intravenous etomidate for procedural sedation in emergency department patients. Acad Emerg Med. 2001 Jan;8(1):13-8. — View Citation

Schenarts CL, Burton JH, Riker RR. Adrenocortical dysfunction following etomidate induction in emergency department patients. Acad Emerg Med. 2001 Jan;8(1):1-7. — View Citation

Scott J, Huskisson EC. Graphic representation of pain. Pain. 1976 Jun;2(2):175-84. — View Citation

Vinson DR, Bradbury DR. Etomidate for procedural sedation in emergency medicine. Ann Emerg Med. 2002 Jun;39(6):592-8. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OSBD-r	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.	immediate
Secondary	Likert satisfaction scale	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.	immediate
Secondary	procedural recall	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.	immediate