This observational study is being conducted to determine plasma concentrations of tetrahydrocannabinol (THC) and its metabolites, 11-OH-THC and THC-COOH, in plasma of pediatric patients who visit the emergency department due to acute cannabis-induced CNS depression.
This is a multi-center, prospective, cross-sectional observational study to determine the concentrations of tetrahydrocannabinol (THC) and its metabolites (and/or other cannabinoids) in the plasma of pediatric patients admitted to emergency departments with acute cannabis-induced CNS depression. .The study will explore the relationships between these concentrations and parameters such as demographics, symptom severity, time to symptom resolution, and clinical outcomes. Samples will be collected as part of standard clinical procedure without requiring study participants to spend additional time in the hospital.
Study Type
OBSERVATIONAL
Enrollment
36
University of Massachusetts Memorial Children's Medical Center
Worcester, Massachusetts, United States
RECRUITINGPlasma Concentration of delta-9 tetrahydrocannabinol (THC)
Concentration of THC and THC metabolites (11-OH-THC and THC-COOH) in plasma of subjects admitted to emergency departments due to acute cannabis induced CNS depression.
Time frame: Day 1
Demographics
Describe the demographics of patients with acute cannabis-induced CNS depression
Time frame: Baseline
Cannabis Exposure
Dose of cannabis ingested
Time frame: Baseline
Cannabis-Related Symptoms
Clinical symptoms resulting from cannabis exposure
Time frame: Baseline, 30 minutes, 1 hour, 6 hours
Richmond Agitation and Sedation (RASS) Score
The RASS evaluates a patient's level of agitation or sedation on a 10-point scale ranging from +4 (combative) to -5 (unarousable) with zero representing a calm, alert state
Time frame: Baseline, 30 minutes, 1 hour, 6 hours
Glasgow Coma Scale (GCS) Score
The GCS assesses a patient's level of consciousness based on eye opening, verbal response, and motor response. The total score ranges from 3 (deep unconsciousness to 15 (fully alert)
Time frame: Baseline, 30 minutes, 1 hour, 6 hours
Caregiver Global Impression of Change (CaGI-C)
The CaGI-C is completed by the caregiver or legally authorized representative and captures their overall impression of how the child's condition has changed since arrival at the emergency department. It will be measured using a 7-point Likert scale ranging from 1 (very much improved) to 7 (very much worse)
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Time frame: Baseline, 6 hours
Hospital or Intensive Care Unit Admission
This assesses whether the subject was admitted to the hospital or intensive care unit. It is a binary measure and can be yes or no.
Time frame: From Enrollment Through Time of Discharge, up to 24 hours
Time to Discharge
This assesses the time from arrival at the emergency department until the subject is released. It is measured in minutes.
Time frame: From Enrollment Through Time of Discharge, up to 24 hours
Need for Positive Pressure Ventilation
This is a binary assessment (yes or no) and captures whether the subject required ventilation assistance due to the cannabinoid exposure.
Time frame: From Enrollment Through Time of Discharge, up to 24 hours
Occurrence of Seizures Requiring Intervention
This is a binary assessment (yes or no) and captures whether the subject experienced seizures which required intervention during the visit to the emergency department.
Time frame: From Enrollment Through Time of Discharge, up to 24 hours