Emergency Department Procedural SedationPhase 3NCT02079090
Ketofol Versus Fentofol for Procedural Sedation in the Pediatric Emergency Department
A Phase 3 study testing Ketofol and Fentofol in people with Emergency Department Procedural Sedation and Fracture Reduction, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Emergency Department Procedural Sedation, Fracture Reduction
- What is being tested?
- Ketofol and Fentofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2014to Jun 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia: BC Children's Hospital
Vancouver, British Columbia, V6H 3V4
About this study
Official title: Ketofol Versus Fentofol for Procedural Sedation of Children 3 to 17 Years Old: a Double-Blind Randomized Controlled Trial
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.
Read the 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.
- Being tested
- Ketofol, Fentofol
- Keywords
- Propofol, Ketamine, Fentanyl, Procedural sedation, children, Emergency Department
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetofolDrug
0.5 mg/kg Ketamine IV, and 2 minutes later receive 1 mg/kg Propofol (Diprivan).
FentofolDrug
1 microgram/kg Fentanyl, and 2 minutes later receive 1 mg/kg Propofol (Diprivan)
| Study group | Role | What they receive |
|---|---|---|
| Ketofol | Active comparator | Patient will receive 0.5 mg/kg Ketamine, and 2 minutes later receive 1 mg/kg Propofol. Receives: Drug: Ketofol |
| Fentofol | Experimental | Patient will receive 1 microgram/kg Fentanyl, and 2 minutes later receive 1 mg/kg Propofol. Receives: Drug: Fentofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Sedation
Duration of sedation is measured from time of administration of Propofol (time 0) to recovery being achieved.
Measured: Less than 30 minutes
Secondary outcomes (5)
Recovery Time
Measured from time of last dose of study drug administered to recovery
Measured: Less than 30 minutes
Additional analgesia or sedation medications
Use of additional analgesic agents and sedation medications to complete PSA
Measured: Less than 30 minutes
Efficacy of sedation for completion of procedure
A sedation is considered efficacious if: the patient does not have unpleasant recall of the procedure, the patient did not experience sedation-related adverse events resulting in abandonment of the procedure/permanent complication/unplanned admission to the hospital or ED, and the patient did not actively resist the procedure or require restraints.
Measured: Less than 30 minutes
Satisfaction with sedation
Satisfaction scores will be completed by the physician performing the sedation, the physician performing the procedure, the nurse performing the sedation and by the patient in the ED. This outcome will by measured using a 5-point Likert scale, except in children between ages 6 and 9, where a 5-point facial hedonic scale is used.
Measured: Less than 60 minutes
Incidence of adverse events
Adverse events, interventions and outcomes will be measured using the "Quebec Guidelines".
Measured: From initiation of PSA until 48 to 72 hours post-ED discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startJul 2014
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Emergency Department Procedural SedationStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Child and Family Research Institute
- Responsible party
- Principal investigator, Vikram Sabhaney, University of British Columbia
- Investigators
- Vikram Sabhaney, MD, Principal investigator, University of British Columbia, BC Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02079090
- Sponsor's protocol ID
- H14-00273
- Status last verified
- Oct 2017
- First submitted
- 1 Mar 2014
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21256625Mallory 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.
PubMed 21513827Andolfatto 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.
PubMed 20370749Shah 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.
PubMed 20947210Godambe 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.
PubMed 12837876Kennedy 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.
PubMed 9755272Messenger 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.
PubMed 18754820Chiaretti 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.
PubMed 19490010Tosun 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.
PubMed 18095965Bhatt 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.
PubMed 19026467
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketofol Versus Fentofol for Procedural Sedation of Children 3 to 17 Years Old: a Double-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02079090
- Acronym / sponsor ID
- H14-00273
- Keywords
- Propofol, Ketamine, Fentanyl, Procedural sedation, children, Emergency Department
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Child and Family Research Institute
- Study start
- Jul 2014
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 5 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketofol | Active comparator | Drug: KetofolPatient will receive 0.5 mg/kg Ketamine, and 2 minutes later receive 1 mg/kg Propofol. |
| Fentofol | Experimental | Drug: FentofolPatient will receive 1 microgram/kg Fentanyl, and 2 minutes later receive 1 mg/kg Propofol. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketofol0.5 mg/kg Ketamine IV, and 2 minutes later receive 1 mg/kg Propofol (Diprivan). | Drug | Ketofol |
| Fentofol1 microgram/kg Fentanyl, and 2 minutes later receive 1 mg/kg Propofol (Diprivan) | Drug | Fentofol |
Primary outcome
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.
5 secondary outcomes
Recovery Time
Time frame: Less than 30 minutes
Additional analgesia or sedation medications
Time frame: Less than 30 minutes
Efficacy of sedation for completion of procedure
Time frame: Less than 30 minutes
Satisfaction with sedation
Time frame: Less than 60 minutes
Incidence of adverse events
Time frame: From initiation of PSA until 48 to 72 hours post-ED discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- Background: PubMed 21256625Green 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.
- Background: PubMed 21513827Mallory 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.
- Background: PubMed 20370749Andolfatto 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.
- Background: PubMed 20947210Shah 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.
- Background: PubMed 12837876Godambe 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.
- Background: PubMed 9755272Kennedy 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.
- Background: PubMed 18754820Messenger 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.
- Background: PubMed 19490010Chiaretti 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.
- Background: PubMed 18095965Tosun 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.
- Background: PubMed 19026467Bhatt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vikram Sabhaney, MD principal investigator
University of British Columbia, BC Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketofol and Fentofol in people with Emergency Department Procedural Sedation and Fracture Reduction, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Sedation (time frame: Less than 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02079090, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2017.