Oral Clonidine-Based Strategy to Reduce Opiate Use During Cooling for Neonatal Encephalopathy: An Observational Study

Area of Science:

• Neonatal Neurology
• Pediatric Critical Care
• Pharmacology

Background:

• Therapeutic hypothermia (TH) is a standard treatment for neonatal hypoxic-ischemic encephalopathy (HIE).
• Sedation is crucial during TH, with morphine-based (MOR) strategies being common.
• Alternative sedation protocols are needed to optimize opiate use and hemodynamic stability.

Purpose of the Study:

• To compare an enteral clonidine-based sedation strategy (CLON) with a morphine-based strategy (MOR) in neonates undergoing TH for HIE.
• To evaluate the impact of CLON on opiate requirements, safety, and efficacy.
• To assess hemodynamic changes and the need for additional vasoactive support.

Main Methods:

• Single-center, observational study in a level IV NICU from January 2017 to October 2021.
• Patients were grouped into MOR (before April 2020) and CLON (after August 2020) based on protocol transition.
• Primary outcome: total and rescue morphine milligram equivalent/kg; Secondary outcome: hemodynamic changes.

Main Results:

• The CLON group (25 neonates) showed significantly lower morphine milligram equivalent/kg and need for rescue opiates compared to the MOR group (74 neonates).
• Fewer patients in the CLON group required rescue opiates as TH days advanced.
• The MOR group experienced more frequent hypotension, requiring greater dopamine doses and additional inotropes/hydrocortisone.

Conclusions:

• The enteral clonidine-based sedation protocol is noninferior to the morphine-based strategy for neonates with HIE undergoing TH.
• CLON appears to reduce opiate and inotrope requirements while maintaining perceived effectiveness and hemodynamic safety.
• This suggests CLON as a viable alternative for sedation during TH in HIE.