Ketamine/Propofol vs Ketamine Alone for Pediatric Fracture Reduction

NCT00490997 | Completed Phase 4 DMC

• 2 other identifiers: R-07-017IRF 044-06
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to compare Ketamine-Propofol with Ketamine-only in a double-blind, randomised, controlled trial in a paediatric emergency department. We believe that the combination of these two agents will provide a new and more effective option for procedural sedation in paediatric emergency department patients. The hypothesis of the study is that paediatric emergency department patients requiring procedural sedation for an isolated orthopaedic injury with Ketamine-Propofol will have reduced total sedation time, time to recovery, complications and improved satisfaction scores compared to patients receiving Ketamine alone.

Conditions

Fractures

Keywords

ketamine; propofol; sedation; pediatric; emergency department; fracture

Outcome Measures

Primary Outcomes (1)

• Total Sedation Time

  defined as the time that the first study drug was injected until the patient is fully recovered with a minimum recovery score ≥ 8

Secondary Outcomes (3)

• Time to Recovery

  defined as the time interval from the last study drug given to recovery score ≥ 8

• patient, nurse, and physician satisfaction

  during and immediately after sedation

• complications and adverse events

  during and immediately after sedation

Study Arms (2)

1

ACTIVE COMPARATOR

Ketamine only arm

Drug: Ketamine only

2

ACTIVE COMPARATOR

Ketamine-Propofol arm

Drug: Ketamine - Propofol

Interventions

Ketamine only DRUG

Ketamine 1.0 mg/kg IV and placebo intralipid as initial sedation agents (double blinded). Ketamine .25 mg/kg IV and placebo intralipid q2 minutes prn for additional sedation

1

Ketamine - Propofol DRUG

Ketamine .5 mg/kg and Propofol 1 mg/kg as initial sedation agents (double-blinded). Saline Placebo and Propofol .5 mg/kg q 2minutes for additional sedation

2

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Healthy pediatric emergency patients with isolated extremity injury requiring reduction

You may not qualify if:

• Active respiratory illness
• Seizure disorder
• Craniofacial abnormalities
• Allergy to soy, ketamine, or propofol
• Hypertension
• Significant renal, cardiovascular or neurologic disease

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• University of Western Ontario, Canada: collaborator

Study Sites (1)

Children's Hospital of Western Ontario

London, Ontario, N6H 5B8, Canada

Location

Related Publications (5)

• Krauss B, Green SM. Procedural sedation and analgesia in children. Lancet. 2006 Mar 4;367(9512):766-80. doi: 10.1016/S0140-6736(06)68230-5.

  PMID: 16517277 BACKGROUND

• Willman EV, Andolfatto G. A prospective evaluation of "ketofol" (ketamine/propofol combination) for procedural sedation and analgesia in the emergency department. Ann Emerg Med. 2007 Jan;49(1):23-30. doi: 10.1016/j.annemergmed.2006.08.002. Epub 2006 Oct 23.

  PMID: 17059854 BACKGROUND

• Roback MG, Wathen JE, MacKenzie T, Bajaj L. A randomized, controlled trial of i.v. versus i.m. ketamine for sedation of pediatric patients receiving emergency department orthopedic procedures. Ann Emerg Med. 2006 Nov;48(5):605-12. doi: 10.1016/j.annemergmed.2006.06.001. Epub 2006 Aug 14.

  PMID: 17052563 BACKGROUND

• 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.

  PMID: 12837876 BACKGROUND

• Cravero JP, Blike GT, Beach M, Gallagher SM, Hertzog JH, Havidich JE, Gelman B; Pediatric Sedation Research Consortium. Incidence and nature of adverse events during pediatric sedation/anesthesia for procedures outside the operating room: report from the Pediatric Sedation Research Consortium. Pediatrics. 2006 Sep;118(3):1087-96. doi: 10.1542/peds.2006-0313.

  PMID: 16951002 BACKGROUND

MeSH Terms

Conditions

Fractures, Bone; Emergencies

Condition Hierarchy (Ancestors)

Wounds and Injuries; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Amit P Shah, MD FCFP(EM)

  Western University, Canada

  PRINCIPAL INVESTIGATOR

• Greg Mosdossy, MD, FRCPC

  Western University, Canada

  PRINCIPAL INVESTIGATOR

• Michael J Rieder, MD PhD FRCPC

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2007
• First Posted: June 25, 2007
• Study Start: June 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: August 25, 2017

Record last verified: 2008-08

Locations

CA (1)