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

NCT01387139 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 10-0835
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Procedural Sedation and Analgesia

Keywords

Ketamine; Propofol; Procedural Sedation and Analgesia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Recovery Time

  Once Vancouver Sedation Recovery Scale Score reaches 18 or greater, on average less than 1 hour

• Efficacy of Sedation

  After procedure is completed, on average less than 1 hour

• Parent Satisfaction

  After procedure is completed, on average less than 1 hour

• Physician Performing Procedure Satisfaction

  After procedure is completed, on average less than 1 hour

• Nurse Satisfaction

  After procedure is completed, on average less than 1 hour

Study Arms (2)

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)

Drug: Ketamine

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)

Drug: Ketamine Co-administered with Propofol

Interventions

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)

Ketamine Alone

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)

Ketamine Co-Administered with Propofol

Eligibility Criteria

• Age: 3 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Colorado Clinical & Translational Sciences Institute: collaborator

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (13)

• 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.

  PMID: 15930401 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.

  PMID: 11097698 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.

  PMID: 16132313 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.

  PMID: 15936092 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.

  PMID: 15896585 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.

  PMID: 14617116 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.

  PMID: 18091596 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.

  PMID: 17059854 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.

  PMID: 19224786 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.

  PMID: 17142550 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.

  PMID: 19026467 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.

  PMID: 8001210 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.

  PMID: 2367140 BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Ketamine; Propofol

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic

Results Point of Contact

• Title: Keith Weisz
• Organization: Ucolorado

keith.weisz@childrenscolorado.org

303-724-2592

Study Officials

• Lalit Bajaj, MD, MPH

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Keith Weisz, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2011
• First Posted: July 4, 2011
• Study Start: January 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: November 3, 2017
• Last Updated: December 8, 2017
• Results First Posted: February 17, 2016

Record last verified: 2017-11

Locations

US (1)