Ketamine Versus Co-administration of Ketamine and Propofol for Procedural Sedation in a Pediatric Emergency Department

Condition(s) targeted: Conscious Sedation

Intervention: Ketamine (Drug); Ketamine Co-administered with Propofol (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: University of Colorado, Denver

Official(s) and/or principal investigator(s):
Lalit Bajaj, MD, MPH, Principal Investigator, Affiliation: University of Colorado, Denver
Keith Weisz, MD, Principal Investigator, Affiliation: University of Colorado, Denver

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.

Official title: Comparison of Ketamine Versus Co-Administration of Ketamine and Propofol for Procedural Sedation in a Pediatric Emergency Department

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Frequency of Adverse Events

Secondary outcome:

Recovery Time

Efficacy of Sedation

Levels of Ketamine and Propofol in the blood measured in nanograms per milliliter (ml)

Putative functional polymorphisms in genes that influence inter-individual variability in ketamine and propofol pharmacokinetics

Parent satisfaction

Patient Satisfaction

Physician Performing Procedure Satisfaction

Nurse Satisfaction

Levels of Ketamine and Propofol in the blood measured in nanograms per ml

Levels of Ketamine and Propofol in the blood measured in nanograms per ml

Levels of Ketamine and Propofol in the blood measured in nanograms per ml

Levels of Ketamine and Propofol in the blood measured in nanograms per ml

Putative functional polymorphisms in genes that influence inter-individual variability in ketamine and propofol pharmacokinetics

Putative functional polymorphisms in genes that influence inter-individual variability in ketamine and propofol pharmacokinetics

Putative functional polymorphisms in genes that influence inter-individual variability in ketamine and propofol pharmacokinetics

Putative functional polymorphisms in genes that influence inter-individual variability in ketamine and propofol pharmacokinetics

Detailed description: 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.

Minimum age: 3 Years. Maximum age: 21 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Ages > 3 years and < 21 years

- American Society of Anesthesiologists (ASA) class I or II

- Fracture or dislocation requiring reduction under procedural sedation with ketamine

as deemed by the attending emergency medicine physician

- Parent/Legal Guardian or Patient (if 18 years of age or older) has already given

verbal consent for procedural sedation as part of standard care for their condition Exclusion Criteria:

- Hypertension (Blood Pressure > 95th percentile for age)

- Glaucoma or acute globe injury

- Increased intracranial pressure or central nervous system mass lesion

- Porphyria

- Previous allergic reaction to ketamine

- Previous allergic reaction to Propofol or its components including soybean oil,

glycerol, egg lecithin, and disodium edentate

- Disorders of lipid metabolism including primary hyperlipoproteinemia, diabetic

hyperlipemia, or pancreatitis

- Mitochondrial myopathies or disorders of electron transport

- Pregnancy

- Parent, guardian or patient unwilling/unable to provide informed consent/assent

Children's Hospital Colorado, Aurora, Colorado 80045, United States

Related publications:

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.

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.

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.

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. Epub 2005 Jun 3.

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.

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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.

American Academy of Pediatrics; American Academy of Pediatric Dentistry, Coté 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.

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.

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Starting date: January 2011
Last updated: May 21, 2015