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| Name | Class |
|---|---|
| Colorado Clinical & Translational Sciences Institute | OTHER |
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The purpose of this study is to compare the effectiveness of the co-administration of intravenous ketamine and propofol to intravenous ketamine as a single agent for procedural sedation in the pediatric emergency department. The investigators hypothesize that patients receiving co-administration of ketamine and propofol will have a lower rate of adverse events, compared to patients receiving ketamine for procedural sedation.
Procedural sedation and analgesia (PSA) is a frequent occurrence in pediatric emergency departments. The goals of PSA include maximizing analgesia and amnesia, and minimizing adverse events while ensuring stable cardiopulmonary function. For decades, ketamine has been the main pharmacologic agent used for pediatric PSA. Numerous studies support the use of ketamine for sedation, amnesia, and analgesia on children undergoing painful procedures in the emergency department setting. Research has continually shown ketamine to cause emergence phenomenon, laryngospasm and vomiting.
Propofol is a sedative-hypnotic widely used for procedural sedation in adult emergency departments. The advantages of propofol include rapid onset, with quick and predictable recovery time, and antiemetic effects. Disadvantages include dose-dependent hypotension, bradycardia, respiratory depression, as well as pain with injection. In addition, propofol does not provide any analgesia.
Ketamine and propofol administered together have been successfully utilized in a variety of settings, including dermatologic, cardiovascular, and interventional radiological procedures in children. The co-administration of ketamine and propofol has been shown to preserve sedation while minimizing the respective adverse events. When used in combination, doses administered of each can be reduced, while producing a more stable hemodynamic and respiratory profile. Furthermore, this combination may reduce the frequency of emergence reactions, vomiting, and the pain of propofol injection.
To date, there are no randomized controlled trials evaluating the co-administration of ketamine and propofol versus ketamine monotherapy for PSA in the Pediatric Emergency Department.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine Alone | Active Comparator | 1.0 milligrams/kilogram (mg/kg) ketamine with additional doses of 0.5 mg/kg ketamine as needed (maximum single dose based on 100 kilogram (kg) person) |
|
| Ketamine Co-Administered with Propofol | Experimental | 0.5 mg/kg ketamine and 0.5 mg/kg propofol with additional doses of 0.25 mg/kg ketamine and 0.25 mg/kg propofol as needed (maximum single dose based on 100 kg person) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | 1.0 milligrams/kilogram (mg/kg) ketamine with additional doses of 0.5 mg/kg ketamine as needed (maximum single dose based on 100 kilogram (kg) person) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Adverse Events | We will record all adverse events during the sedation, and then perform a follow-up call to determine if any additional adverse events occured after discharge. | From enrollment through completion of follow-up, up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery Time | Time until the patient has a Vancouver Sedation Recovery Scale Score of 18 or greater. | Once Vancouver Sedation Recovery Scale Score reaches 18 or greater, on average less than 1 hour |
| Efficacy of Sedation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lalit Bajaj, MD, MPH | University of Colorado, Denver | Principal Investigator |
| Keith Weisz, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15930401 | Background | Roback MG, Wathen JE, Bajaj L, Bothner JP. Adverse events associated with procedural sedation and analgesia in a pediatric emergency department: a comparison of common parenteral drugs. Acad Emerg Med. 2005 Jun;12(6):508-13. doi: 10.1197/j.aem.2004.12.009. | |
| 11097698 | Background | Wathen JE, Roback MG, Mackenzie T, Bothner JP. Does midazolam alter the clinical effects of intravenous ketamine sedation in children? A double-blind, randomized, controlled, emergency department trial. Ann Emerg Med. 2000 Dec;36(6):579-88. doi: 10.1067/mem.2000.111131. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ketamine Alone | Ketamine: 1.0 milligrams/kilogram (mg/kg) ketamine with additional doses of 0.5 mg/kg ketamine as needed (maximum single dose based on 100 kilogram (kg) person) |
| FG001 | Ketamine Co-Administered With Propofol |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Ketamine Co-administered with Propofol | Drug | 0.5 mg/kg ketamine and 0.5 mg/kg propofol with additional doses of 0.25 mg/kg ketamine and 0.25 mg/kg propofol as needed (maximum single dose based on 100 kg person) |
|
Efficacy is defined as:
| After procedure is completed, on average less than 1 hour |
| Parent Satisfaction | Measured on a 10-point scale (1= least satisfied, 10= most satisfied) | After procedure is completed, on average less than 1 hour |
| Physician Performing Procedure Satisfaction | Measured on a 10-point scale (1= least satisfied, 10= most satisfied) | After procedure is completed, on average less than 1 hour |
| Nurse Satisfaction | Measured on a 10-point scale (1= least satisfied, 10= most satisfied) | After procedure is completed, on average less than 1 hour |
| 16132313 | Background | Akin A, Esmaoglu A, Guler G, Demircioglu R, Narin N, Boyaci A. Propofol and propofol-ketamine in pediatric patients undergoing cardiac catheterization. Pediatr Cardiol. 2005 Sep-Oct;26(5):553-7. doi: 10.1007/s00246-004-0707-4. |
| 15936092 | Background | Akin A, Esmaoglu A, Tosun Z, Gulcu N, Aydogan H, Boyaci A. Comparison of propofol with propofol-ketamine combination in pediatric patients undergoing auditory brainstem response testing. Int J Pediatr Otorhinolaryngol. 2005 Nov;69(11):1541-5. doi: 10.1016/j.ijporl.2005.04.011. Epub 2005 Jun 3. |
| 15896585 | Background | Akin A, Guler G, Esmaoglu A, Bedirli N, Boyaci A. A comparison of fentanyl-propofol with a ketamine-propofol combination for sedation during endometrial biopsy. J Clin Anesth. 2005 May;17(3):187-90. doi: 10.1016/j.jclinane.2004.06.019. |
| 14617116 | Background | Barbi E, Marchetti F, Gerarduzzi T, Neri E, Gagliardo A, Sarti A, Ventura A. Pretreatment with intravenous ketamine reduces propofol injection pain. Paediatr Anaesth. 2003 Nov;13(9):764-8. doi: 10.1046/j.1460-9592.2003.01150.x. |
| 18091596 | Background | Sharieff GQ, Trocinski DR, Kanegaye JT, Fisher B, Harley JR. Ketamine-propofol combination sedation for fracture reduction in the pediatric emergency department. Pediatr Emerg Care. 2007 Dec;23(12):881-4. doi: 10.1097/pec.0b013e31815c9df6. |
| 17059854 | Background | 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. doi: 10.1016/j.annemergmed.2006.08.002. Epub 2006 Oct 23. |
| 19224786 | Background | Cravero JP, Beach ML, Blike GT, Gallagher SM, Hertzog JH; Pediatric Sedation Research Consortium. The incidence and nature of adverse events during pediatric sedation/anesthesia with propofol for procedures outside the operating room: a report from the Pediatric Sedation Research Consortium. Anesth Analg. 2009 Mar;108(3):795-804. doi: 10.1213/ane.0b013e31818fc334. |
| 17142550 | Background | American Academy of Pediatrics; American Academy of Pediatric Dentistry; Cote CJ, Wilson S; Work Group on Sedation. Guidelines for monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures: an update. Pediatrics. 2006 Dec;118(6):2587-602. doi: 10.1542/peds.2006-2780. |
| 19026467 | 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. |
| 8001210 | Background | Macnab AJ, Levine M, Glick N, Phillips N, Susak L, Elliott M. The Vancouver sedative recovery scale for children: validation and reliability of scoring based on videotaped instruction. Can J Anaesth. 1994 Oct;41(10):913-8. doi: 10.1007/BF03010934. |
| 2367140 | Background | Bieri D, Reeve RA, Champion DG, Addicoat L, Ziegler JB. The Faces Pain Scale for the self-assessment of the severity of pain experienced by children: development, initial validation, and preliminary investigation for ratio scale properties. Pain. 1990 May;41(2):139-150. doi: 10.1016/0304-3959(90)90018-9. |
Ketamine Co-administered with Propofol: 0.5 mg/kg ketamine and 0.5 mg/kg propofol with additional doses of 0.25 mg/kg ketamine and 0.25 mg/kg propofol as needed (maximum single dose based on 100 kg person)
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketamine Alone | |
| BG001 | Ketamine Co-Administered With Propofol | |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Frequency of Adverse Events | We will record all adverse events during the sedation, and then perform a follow-up call to determine if any additional adverse events occured after discharge. | Adverse events | Posted | Number | participants | From enrollment through completion of follow-up, up to 7 days |
|
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| Secondary | Recovery Time | Time until the patient has a Vancouver Sedation Recovery Scale Score of 18 or greater. | Posted | Median | Inter-Quartile Range | minutes | Once Vancouver Sedation Recovery Scale Score reaches 18 or greater, on average less than 1 hour |
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| Secondary | Efficacy of Sedation | Efficacy is defined as:
| Posted | Number | participants | After procedure is completed, on average less than 1 hour |
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| Secondary | Parent Satisfaction | Measured on a 10-point scale (1= least satisfied, 10= most satisfied) | Posted | Median | Inter-Quartile Range | units on a scale (1-10) | After procedure is completed, on average less than 1 hour |
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| Secondary | Physician Performing Procedure Satisfaction | Measured on a 10-point scale (1= least satisfied, 10= most satisfied) | Posted | Median | Inter-Quartile Range | units on a scale | After procedure is completed, on average less than 1 hour |
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| Secondary | Nurse Satisfaction | Measured on a 10-point scale (1= least satisfied, 10= most satisfied) | Posted | Median | Inter-Quartile Range | units on a scale | After procedure is completed, on average less than 1 hour |
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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 Alone | 0 | 99 | 38 | 99 | |||
| EG001 | Ketamine Co-Administered With Propofol | 0 | 84 | 33 | 84 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory depression | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders |
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| Cardiovascular event | Cardiac disorders |
| |||
| Unpleasant recovery Reaction | Psychiatric disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Keith Weisz | Ucolorado | 303-724-2592 | keith.weisz@childrenscolorado.org |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| vomiting/retching |
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| Unpleasant recovery reaction |
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