Efficacy and Safety of Continuous Infusion of Ketamine in Pediatric Intensive Care Unit (KISS Study)

NCT04427605 | Completed

• 2 other identifiers: AOP1795CESC
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

This study, prospectively evaluate the efficacy and safety of ketamine administered in continuous infusion lasted more than 12 hours in children admitted to Pediatric Intensive Care Unit of Padova. This drug may be used as adopted as adopted as adjuvant to analgesia and sedation or as adjuvant to bronchospasm therapy. The investigators evaluated efficacy considering the sparing of other analgesics and sedatives and the level of sedation after ketamine infusion for the first use and the sparing of other bronchospasm drugs sedative dosage for the second use. To evaluate safety the investigators considered the presence of adverse effects and onset of withdrawal and delirium syndrome. The study will included al least 55 pediatric patients \< 18 years and mechanically ventilated.

Conditions

Analgesia; Ketamine Toxicity; Bronchospasm; Sedation Complication

Keywords

pediatric intensive care unit; ketamine; sedation

Outcome Measures

Primary Outcomes (1)

• level of sedation measured with Comfort Behavior Scale (CBS)

  CBS score decreased \> 2 points after ketamine administration

  12 hours

Secondary Outcomes (2)

• incidence adverse effects,delirium and withdrawal syndrome, assessed by physician (also using Cornell Assessment scale of Pediatric Delirium and Withdrawal Assessment tool 1)

  evaluation during all the duration of ketamine infusion till to 48 hours after the end of it

• bronchospasm severity

  12 hours

Other Outcomes (1)

• presence of hypotension

  12 hours

Study Arms (1)

ketamine group

ketamine intravenous infusion in pediatric patients refractory to conventional analgesic-sedative strategy lasted more than 12 hours (dose range 10-50 mcg/Kg/min)

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Study population is composed by paediatric patients admitted in PICU treated with ketamine (lasted more than 12 hours) during mechanical ventilation in the studied period.

You may qualify if:

• pediatric intensive care unit admission
• mechanical ventilation
• ketamine infusion \> 12 hours

You may not qualify if:

• parents refusal to participate

Sponsors & Collaborators

• Azienda Ospedaliera di Padova: lead

Study Sites (1)

Azienda Ospedale Università Padova

Padua, PD, 35127, Italy

Location

Related Publications (7)

• Heiberger AL, Ngorsuraches S, Olgun G, Luze L, Leimbach C, Madison H, Lakhani SA. Safety and Utility of Continuous Ketamine Infusion for Sedation in Mechanically Ventilated Pediatric Patients. J Pediatr Pharmacol Ther. 2018 Nov-Dec;23(6):447-454. doi: 10.5863/1551-6776-23.6.447.

  PMID: 30697129 BACKGROUND

• Zanos P, Moaddel R, Morris PJ, Riggs LM, Highland JN, Georgiou P, Pereira EFR, Albuquerque EX, Thomas CJ, Zarate CA Jr, Gould TD. Ketamine and Ketamine Metabolite Pharmacology: Insights into Therapeutic Mechanisms. Pharmacol Rev. 2018 Jul;70(3):621-660. doi: 10.1124/pr.117.015198.

  PMID: 29945898 BACKGROUND

• Miller AC, Jamin CT, Elamin EM. Continuous intravenous infusion of ketamine for maintenance sedation. Minerva Anestesiol. 2011 Aug;77(8):812-20.

  PMID: 21730929 BACKGROUND

• Golding CL, Miller JL, Gessouroun MR, Johnson PN. Ketamine Continuous Infusions in Critically Ill Infants and Children. Ann Pharmacother. 2016 Mar;50(3):234-41. doi: 10.1177/1060028015626932. Epub 2016 Jan 18.

  PMID: 26783355 BACKGROUND

• Neunhoeffer F, Hanser A, Esslinger M, Icheva V, Kumpf M, Gerbig I, Hofbeck M, Michel J. Ketamine Infusion as a Counter Measure for Opioid Tolerance in Mechanically Ventilated Children: A Pilot Study. Paediatr Drugs. 2017 Jun;19(3):259-265. doi: 10.1007/s40272-017-0218-4.

  PMID: 28299720 BACKGROUND

• Allen JY, Macias CG. The efficacy of ketamine in pediatric emergency department patients who present with acute severe asthma. Ann Emerg Med. 2005 Jul;46(1):43-50. doi: 10.1016/j.annemergmed.2005.02.024.

  PMID: 15988425 BACKGROUND

• Petrillo TM, Fortenberry JD, Linzer JF, Simon HK. Emergency department use of ketamine in pediatric status asthmaticus. J Asthma. 2001 Dec;38(8):657-64. doi: 10.1081/jas-100107543.

  PMID: 11758894 BACKGROUND

MeSH Terms

Conditions

Agnosia; Bronchial Spasm

Condition Hierarchy (Ancestors)

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

Study Officials

• angela amigoni, MD

  Azienda Ospedaliera di Padova

  PRINCIPAL INVESTIGATOR

• andrea pettenazzo, MD

  Azienda Ospedaliera di Padova

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 11, 2020
• Study Start: April 1, 2019
• Primary Completion: July 31, 2021
• Study Completion: September 1, 2021
• Last Updated: February 15, 2022

Record last verified: 2022-02

Locations

IT (1)