Ketofol Versus Fentofol for Procedural Sedation in the Pediatric Emergency Department

NCT02079090 | Completed Phase 3 DMC

• 1 other identifier: H14-00273
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Sedation and pain medication is required when bone fractures need to be fixed in the emergency department (ED). Many drugs have been used safely as single agents or in combination for the sedation of children. These drugs include Propofol, Ketamine and Fentanyl. However each of these medications has side effects and drawbacks. The combination of Propofol and Fentanyl (Fentofol) has never been compared directly with the combination of Propofol and Ketamine (Ketofol) for painful procedures in the ED, and the goal of this study is to determine which combination works better. The primary outcome of this study is to determine which drug combination has a shorter time from onset of sedation to full recovery. The investigators hypothesize that Fentofol will have shorter sedation to recovery times.

Conditions

Emergency Department Procedural Sedation; Fracture Reduction

Keywords

Propofol; Ketamine; Fentanyl; Procedural sedation; children; Emergency Department

Outcome Measures

Primary Outcomes (1)

• Duration of Sedation

  Duration of sedation is measured from time of administration of Propofol (time 0) to recovery being achieved.

  Less than 30 minutes

Secondary Outcomes (5)

• Recovery Time

  Less than 30 minutes

• Additional analgesia or sedation medications

  Less than 30 minutes

• Efficacy of sedation for completion of procedure

  Less than 30 minutes

• Satisfaction with sedation

  Less than 60 minutes

• Incidence of adverse events

  From initiation of PSA until 48 to 72 hours post-ED discharge

Study Arms (2)

Ketofol

ACTIVE COMPARATOR

Patient will receive 0.5 mg/kg Ketamine, and 2 minutes later receive 1 mg/kg Propofol.

Drug: Ketofol

Fentofol

EXPERIMENTAL

Patient will receive 1 microgram/kg Fentanyl, and 2 minutes later receive 1 mg/kg Propofol.

Drug: Fentofol

Interventions

Ketofol DRUG

0.5 mg/kg Ketamine IV, and 2 minutes later receive 1 mg/kg Propofol (Diprivan).

Ketofol

Fentofol DRUG

1 microgram/kg Fentanyl, and 2 minutes later receive 1 mg/kg Propofol (Diprivan)

Fentofol

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children 3-17 years of age
• Presenting to the ED for assessment of a long bone fracture
• Require PSA for closed reduction of the fracture
• American Society of Anesthesia Grade I or II

You may not qualify if:

• Families not providing informed consent (or assent where appropriate)
• Families unable to communicate in English
• Children sustained life- or limb-threatening injuries
• Children involved in a multi-system trauma
• Children with a pathological fractures
• Children with a contraindication to using Propofol, Ketamine or Fentanyl:
• Allergy or previous adverse reaction to study drugs Psychosis/schizophrenia Active upper respiratory tract infection or asthma, or chronic respiratory illnesses Coronary artery disease, congestive heart failure, hypertension, or chronic cardiac disease Chronic renal disease Increased intracranial pressure Porphyria or thyroid disorder
• Severe developmental delay or autism

Sponsors & Collaborators

• University of British Columbia: lead
• Child and Family Research Institute: collaborator

Study Sites (1)

University of British Columbia: BC Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

Related Publications (10)

• Green SM, Roback MG, Kennedy RM, Krauss B. Clinical practice guideline for emergency department ketamine dissociative sedation: 2011 update. Ann Emerg Med. 2011 May;57(5):449-61. doi: 10.1016/j.annemergmed.2010.11.030. Epub 2011 Jan 21.

  PMID: 21256625 BACKGROUND

• Mallory MD, Baxter AL, Yanosky DJ, Cravero JP; Pediatric Sedation Research Consortium. Emergency physician-administered propofol sedation: a report on 25,433 sedations from the pediatric sedation research consortium. Ann Emerg Med. 2011 May;57(5):462-8.e1. doi: 10.1016/j.annemergmed.2011.03.008.

  PMID: 21513827 BACKGROUND

• Andolfatto G, Willman E. A prospective case series of pediatric procedural sedation and analgesia in the emergency department using single-syringe ketamine-propofol combination (ketofol). Acad Emerg Med. 2010 Feb;17(2):194-201. doi: 10.1111/j.1553-2712.2009.00646.x.

  PMID: 20370749 BACKGROUND

• Shah A, Mosdossy G, McLeod S, Lehnhardt K, Peddle M, Rieder M. A blinded, randomized controlled trial to evaluate ketamine/propofol versus ketamine alone for procedural sedation in children. Ann Emerg Med. 2011 May;57(5):425-33.e2. doi: 10.1016/j.annemergmed.2010.08.032. Epub 2010 Oct 13.

  PMID: 20947210 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

• 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.

  PMID: 9755272 BACKGROUND

• Messenger DW, Murray HE, Dungey PE, van Vlymen J, Sivilotti ML. Subdissociative-dose ketamine versus fentanyl for analgesia during propofol procedural sedation: a randomized clinical trial. Acad Emerg Med. 2008 Oct;15(10):877-86. doi: 10.1111/j.1553-2712.2008.00219.x. Epub 2008 Aug 27.

  PMID: 18754820 BACKGROUND

• Chiaretti A, Ruggiero A, Barone G, Antonelli A, Lazzareschi I, Genovese O, Paiano S, Sammartino M, Maurizi P, Riccardi R. Propofol/alfentanil and propofol/ketamine procedural sedation in children with acute lymphoblastic leukaemia: safety, efficacy and their correlation with pain neuromediator expression. Eur J Cancer Care (Engl). 2010 Mar;19(2):212-20. doi: 10.1111/j.1365-2354.2008.01006.x. Epub 2009 May 21.

  PMID: 19490010 BACKGROUND

• Tosun Z, Esmaoglu A, Coruh A. Propofol-ketamine vs propofol-fentanyl combinations for deep sedation and analgesia in pediatric patients undergoing burn dressing changes. Paediatr Anaesth. 2008 Jan;18(1):43-7. doi: 10.1111/j.1460-9592.2007.02380.x.

  PMID: 18095965 BACKGROUND

• Bhatt M, Kennedy RM, Osmond MH, Krauss B, McAllister JD, Ansermino JM, Evered LM, Roback MG; Consensus Panel on Sedation Research of Pediatric Emergency Research Canada (PERC) and the Pediatric Emergency Care Applied Research Network (PECARN). Consensus-based recommendations for standardizing terminology and reporting adverse events for emergency department procedural sedation and analgesia in children. Ann Emerg Med. 2009 Apr;53(4):426-435.e4. doi: 10.1016/j.annemergmed.2008.09.030. Epub 2008 Nov 20.

  PMID: 19026467 BACKGROUND

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

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

Study Officials

• Vikram Sabhaney, MD

  University of British Columbia, BC Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 1, 2014
• First Posted: March 5, 2014
• Study Start: July 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: October 27, 2017

Record last verified: 2017-10

Locations

CA (1)