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Patients meeting inclusion criteria was low, and PI went to another institution.
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| Name | Class |
|---|---|
| Maimonides Medical Center | OTHER |
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Direct comparison of intranasal sub-dissociative dose ketamine with intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department.
Intranasal (IN) delivery of analgesic agents provides rapid and convenient drug administration without the need for needles. In children, the placement of an intravenous line often increases anxiety and pain, requires nursing time, and can be very difficult to achieve, so the IN route is particularly advantageous. IN delivery of fentanyl has become increasingly more common in pain management for children in many settings, including pre-hospital and emergency department (ED) settings. Over the past decade, many studies have demonstrated that intranasal fentanyl is as effective as intravenous morphine to treat acute moderate to severe pain. Intranasal fentanyl has become standard of care in some pediatric EDs with the advantage of avoiding intravenous line placement. However, adverse effects attributed to IN fentanyl are similar to those of other opioid analgesics: hypotension, sedation, and occasionally respiratory depression. Ketamine is a noncompetitive N-methyl D-aspartate (NMDA) receptor antagonist that blocks the release of the excitatory neurotransmitter glutamate and provides anesthesia, amnesia, and analgesia by decreasing central sensitization and "wind-up" phenomenon. Due to its high lipid solubility, ketamine rapidly crosses the blood-brain barrier, provides rapid onset of action (peak concentration at 1 minute after intravenous push) and rapid recovery to baseline (duration of action 5-15 minutes after intravenous push). At sub-dissociative doses, either used as an adjunct to opioid analgesics or as a solo agent, ketamine provides effective analgesia while preserving airway patency, ventilation, and cardiovascular stability.
Ketamine has been less studied for pain management, however it has been safely used via different routes of administration in children. Studies dating back to 1990's use ketamine at doses as high as 6 mg/kg intranasally in children for pre-medication prior to surgery or for sedation with little or no reported adverse effects. A hospital in Australia is currently conducting a clinical trial comparing IN fentanyl 1.5 ug/kg to IN ketamine 1mg/kg for the treatment of pain caused by isolated musculoskeletal injury. The intention of our study is similar to this, however the investigators will not limit the patients to those with only musculoskeletal pain and a more simplified pain scale will be used.
To assess pain, the investigators will use the standard pain scale that is currently used in our Pediatric ED in order to minimize the need to re-train any of our staff with a different pain scale. The scale incorporates the Numerical rating scale (0-10 scale; NRS) and the Wong-Baker faces pain scale (6 faces corresponding to 0,2,4,6,8,10; WBS). While prior studies have used different pain scales, primarily the visual analog scale (VAS), the scales that the investigator currently use have been validated in children in 2009.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine | Experimental | intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department. |
|
| Fentanyl | Active Comparator | intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score at 30 Minutes | An 11 point Likert Visual Analog Scale with 0 being no pain, 5 being moderate pain and 10 being very severe pain was verbally administered to the patient at 30 minutes post administration of analgesia. | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events at 30 Minutes | The patient were asked at 30 minutes post administration of analgesia if they experienced any side effects like nausea, vomiting, headache etc. | 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sabina Zavolkovskaya, MD | Maimonides Medical Center | Principal Investigator |
| Sergey Motov, MD | Maimonides Medical Center | Study Director |
| John Marshall, MD | Maimonides Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maimonides Medical Center | Brooklyn | New York | 11219 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24127709 | Background | Andolfatto G, Willman E, Joo D, Miller P, Wong WB, Koehn M, Dobson R, Angus E, Moadebi S. Intranasal ketamine for analgesia in the emergency department: a prospective observational series. Acad Emerg Med. 2013 Oct;20(10):1050-4. doi: 10.1111/acem.12229. | |
| 17067720 | Background | Borland M, Jacobs I, King B, O'Brien D. A randomized controlled trial comparing intranasal fentanyl to intravenous morphine for managing acute pain in children in the emergency department. Ann Emerg Med. 2007 Mar;49(3):335-40. doi: 10.1016/j.annemergmed.2006.06.016. Epub 2006 Oct 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ketamine | intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department. Ketamine: intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department. |
| FG001 | Fentanyl | intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department. Fentanyl: intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketamine | intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department. Ketamine: intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Score at 30 Minutes | An 11 point Likert Visual Analog Scale with 0 being no pain, 5 being moderate pain and 10 being very severe pain was verbally administered to the patient at 30 minutes post administration of analgesia. | Posted | Mean | Standard Deviation | units on a scale | 30 minutes |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ketamine | intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department. Ketamine: intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizzines | Nervous system disorders | Systematic Assessment | Dizziness |
Small Sample size
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sergey Motov, MD (Prinicipal Investigator) | Maimonides Medical Center | 718-283-8693 | smotov@maimonidesmed.org |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D007649 | Ketamine |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
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| Fentanyl | Drug | intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department. |
|
|
| 19125831 | Background | Borland ML, Clark LJ, Esson A. Comparative review of the clinical use of intranasal fentanyl versus morphine in a paediatric emergency department. Emerg Med Australas. 2008 Dec;20(6):515-20. doi: 10.1111/j.1742-6723.2008.01138.x. |
| 21489168 | Background | Borland M, Milsom S, Esson A. Equivalency of two concentrations of fentanyl administered by the intranasal route for acute analgesia in children in a paediatric emergency department: a randomized controlled trial. Emerg Med Australas. 2011 Apr;23(2):202-8. doi: 10.1111/j.1742-6723.2011.01391.x. Epub 2011 Feb 8. |
| 20003121 | Background | Garra G, Singer AJ, Taira BR, Chohan J, Cardoz H, Chisena E, Thode HC Jr. Validation of the Wong-Baker FACES Pain Rating Scale in pediatric emergency department patients. Acad Emerg Med. 2010 Jan;17(1):50-4. doi: 10.1111/j.1553-2712.2009.00620.x. Epub 2009 Dec 9. |
| Background | Goldman RD: Intranasal drug delivery for children with acute illness. Curr Drug Ther 2006, 1(1):127-130. |
| 22465159 | Background | Grassin-Delyle S, Buenestado A, Naline E, Faisy C, Blouquit-Laye S, Couderc LJ, Le Guen M, Fischler M, Devillier P. Intranasal drug delivery: an efficient and non-invasive route for systemic administration: focus on opioids. Pharmacol Ther. 2012 Jun;134(3):366-79. doi: 10.1016/j.pharmthera.2012.03.003. Epub 2012 Mar 23. |
| 23842536 | Background | Graudins A, Meek R, Egerton-Warburton D, Seith R, Furness T, Chapman R. The PICHFORK (Pain InCHildren Fentanyl OR Ketamine) trial comparing the efficacy of intranasal ketamine and fentanyl in the relief of moderate to severe pain in children with limb injuries: study protocol for a randomized controlled trial. Trials. 2013 Jul 10;14:208. doi: 10.1186/1745-6215-14-208. |
| 20070272 | Background | Holdgate A, Cao A, Lo KM. The implementation of intranasal fentanyl for children in a mixed adult and pediatric emergency department reduces time to analgesic administration. Acad Emerg Med. 2010 Feb;17(2):214-7. doi: 10.1111/j.1553-2712.2009.00636.x. |
| 24268523 | Background | Karlsen AP, Pedersen DM, Trautner S, Dahl JB, Hansen MS. Safety of intranasal fentanyl in the out-of-hospital setting: a prospective observational study. Ann Emerg Med. 2014 Jun;63(6):699-703. doi: 10.1016/j.annemergmed.2013.10.025. Epub 2013 Nov 22. |
| 17898251 | Background | Miner JR, Kletti C, Herold M, Hubbard D, Biros MH. Randomized clinical trial of nebulized fentanyl citrate versus i.v. fentanyl citrate in children presenting to the emergency department with acute pain. Acad Emerg Med. 2007 Oct;14(10):895-8. doi: 10.1197/j.aem.2007.06.036. |
| Background | National Institute of Clinical Studies: Emergency care acute pain management manual, National Health and Medical Research Council. Canberra, Australia: ACT; 2011. |
| 22424915 | Background | Page MG, Katz J, Stinson J, Isaac L, Martin-Pichora AL, Campbell F. Validation of the numerical rating scale for pain intensity and unpleasantness in pediatric acute postoperative pain: sensitivity to change over time. J Pain. 2012 Apr;13(4):359-69. doi: 10.1016/j.jpain.2011.12.010. Epub 2012 Mar 15. |
| 17920976 | Background | Rickard C, O'Meara P, McGrail M, Garner D, McLean A, Le Lievre P. A randomized controlled trial of intranasal fentanyl vs intravenous morphine for analgesia in the prehospital setting. Am J Emerg Med. 2007 Oct;25(8):911-7. doi: 10.1016/j.ajem.2007.02.027. |
| 21175512 | Background | Saunders M, Adelgais K, Nelson D. Use of intranasal fentanyl for the relief of pediatric orthopedic trauma pain. Acad Emerg Med. 2010 Nov;17(11):1155-61. doi: 10.1111/j.1553-2712.2010.00905.x. |
| 24712757 | Background | Yeaman F, Meek R, Egerton-Warburton D, Rosengarten P, Graudins A. Sub-dissociative-dose intranasal ketamine for moderate to severe pain in adult emergency department patients. Emerg Med Australas. 2014 Jun;26(3):237-42. doi: 10.1111/1742-6723.12173. Epub 2014 Apr 8. |
| 23560967 | Background | Yeaman F, Oakley E, Meek R, Graudins A. Sub-dissociative dose intranasal ketamine for limb injury pain in children in the emergency department: a pilot study. Emerg Med Australas. 2013 Apr;25(2):161-7. doi: 10.1111/1742-6723.12059. Epub 2013 Mar 20. |
| Fentanyl |
intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department. Fentanyl: intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Adverse Events at 30 Minutes | The patient were asked at 30 minutes post administration of analgesia if they experienced any side effects like nausea, vomiting, headache etc. | Posted | Count of Participants | Participants | 30 minutes |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 5 |
| 11 |
| EG001 | Fentanyl | intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department. Fentanyl: intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department. | 0 | 11 | 0 | 11 | 1 | 11 |
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| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |