Intravenous Clonidine for Sedation in Infants and Children Who Are Mechanically Ventilated - Dosing Finding Study
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/3/2019 |
| Start Date: | September 2015 |
| End Date: | December 2019 |
| Contact: | Sapna R Kudchadkar, MD |
| Email: | sapna@jhmi.edu |
| Phone: | 410-955-6412 |
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.
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.
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.
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.
Inclusion Criteria:
- Infants and children age: 0-12 months
- Intubated and mechanically ventilated in the JHH PICU
- Meet criteria for starting dexmedetomidine (per PICU protocol)
Exclusion Criteria:
- Postoperative from complex congenital heart disease
- Asphyxia
- Traumatic Brain Injury
- Major Chromosomal anomaly (Trisomy 13, 18)
- Any infant or child who is receiving ECMO therapy
- If death is considered imminent
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