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

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ClinicalTrials.gov Identifier: NCT04427605
Recruitment Status : Completed
First Posted : June 11, 2020
Last Update Posted : February 15, 2022
Sponsor:
Information provided by (Responsible Party):
angela amigoni, Azienda Ospedaliera di Padova

Tracking Information
First Submitted Date June 8, 2020
First Posted Date June 11, 2020
Last Update Posted Date February 15, 2022
Actual Study Start Date April 1, 2019
Actual Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 9, 2020)
level of sedation measured with Comfort Behavior Scale (CBS) [ Time Frame: 12 hours ]
CBS score decreased > 2 points after ketamine administration
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 9, 2020)
  • incidence adverse effects,delirium and withdrawal syndrome, assessed by physician (also using Cornell Assessment scale of Pediatric Delirium and Withdrawal Assessment tool 1) [ Time Frame: evaluation during all the duration of ketamine infusion till to 48 hours after the end of it ]
    incidence of adverse effects and number of patients withf delirium (Cornell Assessment scale of Pediatric Delirium) and withdrawal syndrome (Withdrawal Assessment tool 1)
  • bronchospasm severity [ Time Frame: 12 hours ]
    change of bronchodilator after ketamine infusion
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 9, 2020)
presence of hypotension [ Time Frame: 12 hours ]
change of inotropic therapy after ketamine infusion
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Efficacy and Safety of Continuous Infusion of Ketamine in Pediatric Intensive Care Unit (KISS Study)
Official Title Efficacy and Safety of Continuous Infusion of Ketamine in Pediatric Intensive Care Unit (KISS Study)
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.
Detailed Description Ketamine is an N-Methyl-d-aspartate-receptor-antagonist commonly used over the last decades as an anesthetic and analgesic agent for procedural sedation. The use of ketamine as a prolonged infusion was first described in 1990 and a prolonged infusion of ketamine has been described as a successful strategy for analgesia and sedation in patients with hemodynamic instability, in patients who were mechanically ventilated and poorly responsive to conventional drugs. An other indication for ketamine infusion is the presence of bronchospasm, due to its action in promoting bronchodilatation. However, existing studies on ketamine for prolonged sedation are mainly retrospective and include small sample size, suggesting that this topic needs to be further investigated. The aim of this observational single center study is to describe the use of ketamine used as adjuvant to conventional analgesic and sedative strategy (opioid and benzodiazepine in continuous infusion) as prolonged infusion (i.e. ≥ 12 hr) in pediatric patients. The investigators will evaluate ketamine indications, dosages, infusion duration, adoption of boluses, modality of weaning. Concomitant analgesic and sedative management and monitoring of level of sedation (using a validated scale) are considered measures of efficacy. Sparing of other bronchospasm drugs sedative dosage are considered measures of efficacy if ketamine is used in patients with obstructive respiratory diseases. Presence of adverse effects (including withdrawal syndrome symptoms and delirium) during infusione or 48 hours after weaning are considered measures of safety. Data were collected using a standardized data sheet. The study lasted 18 months to reach a numerosity of 55 patients. All the requested institutional approvals were collected before starting the data collection.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Analgesia
  • Ketamine Toxicity
  • Bronchospasm
  • Sedation Complication
Intervention Not Provided
Study Groups/Cohorts 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)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 12, 2022)
57
Original Estimated Enrollment
 (submitted: June 9, 2020)
55
Actual Study Completion Date September 1, 2021
Actual Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • parents refusal to participate
Sex/Gender
Sexes Eligible for Study: All
Ages up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT04427605
Other Study ID Numbers AOP1795
CESC ( Other Identifier: Local Ethic Committee for clinical trials )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party angela amigoni, Azienda Ospedaliera di Padova
Original Responsible Party Same as current
Current Study Sponsor Azienda Ospedaliera di Padova
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: angela amigoni, MD Azienda Ospedaliera di Padova
Study Director: andrea pettenazzo, MD Azienda Ospedaliera di Padova
PRS Account Azienda Ospedaliera di Padova
Verification Date February 2022