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NCT Number: NCT04427605

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

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.

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Key information

Conditions

Analgesia Agnosia Bronchial Diseases Bronchial Spasm Bronchospasm Ketamine Toxicity Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Respiratory Tract Diseases Sedation Complication Signs and Symptoms

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedale Università Padova

Padova, PD, 35127, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • parents refusal to participate

Treatment and study plan

Primary outcomes

  1. level of sedation measured with Comfort Behavior Scale (CBS)

    Time frame: 12 hours

    CBS score decreased > 2 points after ketamine administration

Secondary outcomes

  1. 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)

  2. bronchospasm severity

    Time frame: 12 hours

    change of bronchodilator after ketamine infusion

Other outcomes

  1. presence of hypotension

    Time frame: 12 hours

    change of inotropic therapy after ketamine infusion

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera di Padova

Other

Registry information

Acronym: KISS

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 11, 2020
Registry last updated
Feb 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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