Clinical Trials Logo
  1. Home
  2. Other
  3. NCT02249039

Intravenous Clonidine for Sedation in Infants and Children Who Are Mechanically Ventilated - Dosing Finding Study

Mechanical Ventilation Complication Clinical Trial

Official title:
Intravenous Clonidine for Sedation in Infants and Children Who Are Mechanically Ventilated - Dosing Finding Study

Clinical Trial Summary

Critically ill infants and children who are mechanically ventilated are often given large doses of opiates and benzodiazepines to provide analgesia-sedation. These drugs significantly cause tolerance and dependence, depresses the drive to breathe, and thus prolongs the need for mechanical ventilation and the associated complications. We propose IV CLON could be used as effectively as DEX.

Clinical Trial Description

All critically ill mechanically ventilated infants and children receive intravenous analgesic-sedatives which often include opiates and benzodiazepines (BENZO). Undesirable side effects from these drugs include respiratory depression, tolerance and dependence. Alpha 2-adrenergic receptor agonists, dexmedetomidine (DEX) and clonidine (CLON) have excellent sedative-analgesics effects, do not cause respiratory depression and are opiate/BENZO sparing. While both are efficacious in providing sedation, several factors have led to a substantial increase in the use of the newer drug DEX over the more established drug CLON in adults, children and infants. However, studies to guide therapy and dosing for infants and children are lacking. While these infants and children do require less opiate/BENZO therapy and fewer days on mechanical ventilation, they quickly develop tolerance to and have significant withdrawal from DEX. This necessitates protracted weaning of DEX and longer length of stay in the pediatric intensive care unit (PICU) since DEX can only be administered as a continuous intravenous (IV) infusion. CLON, on the other hand, has a longer half-life and has formulations that allow for continuous or intermittent IV and oral administration. Dr. Gauda has an approved IND to use the epidural formulation of CLON intravenously in infants and children. The purpose of this pilot study is to determine the effective IV dosing scheme of CLON that can be safely used as an adjunct to analgesic-sedation management for infants and children in the PICU. It will include a total of 24 infants and children with 4 CLON and DEX exposed in each age stratum: 0-3, 4-6, and 7-12 months. We hypothesize that IV CLON can achieve optimal sedation and reduce the need for opiate/BENZO therapy in critically ill infants and children who would otherwise receive DEX, and thus, reduce the length of stay in the PICU. Data from this study will be used to inform a larger randomized trial and will directly benefit infants and children in Baltimore who are critically ill. Funds are requested to cover the cost of the CLON drug levels and the investigational pharmacy. ;

Study Design

Related Conditions & MeSH terms

  • Mechanical Ventilation Complication
Clinical Trial Details
NCT number NCT02249039
Study type Interventional
Source Johns Hopkins University
Contact
Status Completed
Phase Phase 1
Start date September 2015
Completion date December 2019
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05030337 - Optimising Ventilation in Preterms With Closed-loop Oxygen Control N/A
Completed NCT05144607 - Impact of Inspiratory Muscle Pressure Curves on the Ability of Professionals to Identify Patient-ventilator Asynchronies N/A
Recruiting NCT03697785 - Weaning Algorithm for Mechanical VEntilation N/A
Completed NCT05084976 - Parental Perception of COVID-19 Vaccine in Technology Dependent Patients
Active, not recruiting NCT05886387 - a Bayesian Analysis of Three Randomised Clinical Trials of Intraoperative Ventilation
Completed NCT04429399 - Lowering PEEP: Weaning From High PEEP Setting N/A
Recruiting NCT02071524 - Evaluation of the Effects of Fluid Therapy on Respiratory Mechanics N/A
Completed NCT01114022 - Prevention Inhalation of Bacterial by Using Endotracheal Tube Balloon Polyvinyl Chloride or Polyurethane N/A
Completed NCT00893763 - Strategies To Prevent Pneumonia 2 (SToPP2) Phase 2
Terminated NCT05056103 - Automated Secretion Removal in ICU Patients N/A
Active, not recruiting NCT04558476 - Efficacy of CONvalescent Plasma in Patients With COVID-19 Treated With Mechanical Ventilation Phase 2
Recruiting NCT05295186 - PAV Trial During SBT Trial
Active, not recruiting NCT05370248 - The Effect of 6 ml/kg vs 10 ml/kg Tidal Volume on Diaphragm Dysfunction in Critically Mechanically Ventilated Patient N/A
Completed NCT04818164 - Prone Position Improves End-Expiratory Lung Volumes in COVID-19 Acute Respiratory Distress Syndrome
Completed NCT04589910 - Measuring Thickness of the Normal Diaphragm in Children Via Ultrasound. N/A
Completed NCT04193254 - LPP , MP and DP:Relation With Mortality and SOFA in Mechanically Ventilated Patients in ER, Ward and ICU
Not yet recruiting NCT03245684 - Assisted or Controlled Ventilation in Ards (Ascovent) N/A
Completed NCT06332768 - NIV Versus HFO Versus Standard Therapy Immediately After Weaning From Mechanical Ventilation in ARDS Patients N/A
Not yet recruiting NCT03259854 - Non Invasive Mechanical Ventilation VERSUS Oxygen MASK N/A
Completed NCT03335449 - Effects on Respiratory Mechanics of Two Different Ventilation Strategies During Robotic-Gynecological Surgery N/A