Ketofol Versus Fentofol for Procedural Sedation in the Pediatric Emergency Department
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ClinicalTrials.gov Identifier: NCT02079090 |
Recruitment Status :
Completed
First Posted : March 5, 2014
Last Update Posted : October 27, 2017
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Tracking Information | ||||
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First Submitted Date ICMJE | March 1, 2014 | |||
First Posted Date ICMJE | March 5, 2014 | |||
Last Update Posted Date | October 27, 2017 | |||
Study Start Date ICMJE | July 2014 | |||
Actual Primary Completion Date | June 2017 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Duration of Sedation [ Time Frame: Less than 30 minutes ] Duration of sedation is measured from time of administration of Propofol (time 0) to recovery being achieved.
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Ketofol Versus Fentofol for Procedural Sedation in the Pediatric Emergency Department | |||
Official Title ICMJE | Ketofol Versus Fentofol for Procedural Sedation of Children 3 to 17 Years Old: a Double-Blind Randomized Controlled Trial | |||
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. | |||
Detailed Description | Purpose: The purpose of this study is to compare the duration of procedural sedation and analgesia (PSA) from time of medication delivery to recovery for children in the ED provided by Fentofol and Ketofol. Hypothesis: The hypothesis is that Fentofol will have a shorter duration of sedation time as compared to Ketofol. Justification: PSA for children is a common occurrence in the ED and has been performed using Ketamine or Propofol. Propofol offers several advantages over Ketamine, including shorter recovery times, and low rates of nausea and vomiting. Propofol is a potent sedative-hypnotic that does not provide analgesia, hence another agent is commonly used in combination for painful procedures. Propofol has been used in combination with Ketamine (Ketofol) and with Fentanyl (Fentofol) to improve the quality of sedation for painful procedures such as fracture reduction. Ketofol has been shown in a double blind randomized controlled trial to be at least equivalent, or even superior to Ketamine in children who are undergoing PSA, with shorter duration of sedation, increased provider and patient satisfaction, and reduced frequency of nausea/vomiting events. A combination of 1 to 2 microgram/kg Fentanyl and 1 mg/kg Propofol has been shown to substantially reduce recovery time as compared to 0.05 mg/kg Midazolam and 1 to 2 mg/kg Ketamine, and provided adequate levels of analgesia during PSA. As a result, both Ketofol and Fentofol are considered standard treatments for PSA in the ED. However, there is currently no pediatric literature available comparing Ketofol and Fentofol for PSA in the ED setting and the results of this study will potentially identify which of the two sedation agents is superior. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
30 | |||
Original Estimated Enrollment ICMJE |
140 | |||
Actual Study Completion Date ICMJE | June 2017 | |||
Actual Primary Completion Date | June 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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
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Sex/Gender ICMJE |
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Ages ICMJE | 3 Years to 17 Years (Child) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02079090 | |||
Other Study ID Numbers ICMJE | H14-00273 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Vikram Sabhaney, University of British Columbia | |||
Study Sponsor ICMJE | University of British Columbia | |||
Collaborators ICMJE | Child and Family Research Institute | |||
Investigators ICMJE |
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PRS Account | University of British Columbia | |||
Verification Date | October 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |