Ketamine/Propofol vs Ketamine Alone for Pediatric Fracture Reduction - Full Text View

Purpose

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 time to recovery, complications and improved satisfaction scores compared to patients receiving Ketamine alone.

Condition	Intervention	Phase
Fractures	Drug: Ketamine only Drug: Ketamine - Propofol	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:	A Prospective Randomized Double Blind Evaluation of Ketamine/Propofol vs Ketamine Alone for Pediatric Extremity Fracture Reduction

Resource links provided by NLM:

MedlinePlus related topics: Fractures

Drug Information available for: Ketamine hydrochloride Propofol Ketamine

U.S. FDA Resources

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:

recovery time [ Time Frame: time that the last study drug was injected until the patient is fully recovered with a minimum recovery score ≥ 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

time from first drug to procedure start [ Time Frame: during and immediately after sedation ] [ Designated as safety issue: No ]
time from first drug injected to patient recovery [ Time Frame: during and immediately after sedation ] [ Designated as safety issue: No ]
patient, nurse, and physician satisfaction [ Time Frame: during and immediately after sedation ] [ Designated as safety issue: No ]
complications and adverse events [ Time Frame: during and immediately after sedation ] [ Designated as safety issue: Yes ]

Enrollment:	140
Study Start Date:	June 2007
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Ketamine only arm	Drug: Ketamine only 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
Active Comparator: 2 Ketamine-Propofol arm	Drug: Ketamine - Propofol 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

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Eligibility

Ages Eligible for Study:	2 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Healthy pediatric emergency patients with isolated extremity injury requiring reduction

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00490997

Locations

Canada, Ontario
Children's Hospital of Western Ontario
London, Ontario, Canada, N6H 5B8

Sponsors and Collaborators

Lawson Health Research Institute

University of Western Ontario, Canada

Investigators

Principal Investigator:	Amit P Shah, MD FCFP(EM)	University of Western Ontario, Canada
Principal Investigator:	Greg Mosdossy, MD, FRCPC	University of Western Ontario, Canada
Principal Investigator:	Michael J Rieder, MD PhD FRCPC	University of Western Ontario, Canada

More Information

Publications:

Krauss B, Green SM. Procedural sedation and analgesia in children. Lancet. 2006 Mar 4;367(9512):766-80. Review.

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. Epub 2006 Oct 23.

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. Epub 2006 Aug 14.

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.

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.

Responsible Party:	Dr. Amit Shah, Division of Emergency Medicine, University of Western Ontario
ClinicalTrials.gov Identifier:	NCT00490997 History of Changes
Other Study ID Numbers:	R-07-017, IRF 044-06
Study First Received:	June 21, 2007
Last Updated:	August 14, 2008
Health Authority:	Canada: Health Canada

Keywords provided by Lawson Health Research Institute:

ketamine
propofol
sedation

pediatric
emergency department
fracture

Additional relevant MeSH terms:

Fractures, Bone
Wounds and Injuries
Ketamine
Propofol
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
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on May 21, 2013