SUDDEN ONSET OF MARKED BRADYCARDIA, RESITANT TO TREATMENT,PROGRESSING TO COMPLETE HEART BLOCK
CLINICALLY ENLARGED LIVER
METABOLIC ACIDOSIS WITH A BASE DEFICIT OF > 10 MMOL/L ON AT LEAST ONE OCCASION
RHABDOMYOLYSIS OR MYOGLOBINURIA
Propofol marketed in the USA since 11/1989.
PRIS has been described in both children and adult patients sedated with propofol.
FIRST CASE REPORTS- 1992
FDA Investigation of Deaths associated with Propofol
Reviewed reports of death with propofol as the suspect drug: pediatric pt(≤ 16y) and adults(>16y) for non-procedural sedation.
Time period= Nov 1989-Apr 2005.
Metabolic acidosis and/or rhabdomyolysis with progressive cardiac failure US deaths for Nonprocedural sedation reported to the FDA
2yo boy PICU s/p shot in the head with an air gun pellet.
Intubated and ventilated for right sided cerebral edema and rim of subdural blood.
Sedated with propofol rate of 4-5.4 mg/kg/h. over 72 h.
oliguria, increase in K+,BUN, Cr and then sudden, persistent bradycardia(HR= 28).
Propofol stopped, trans-venous pacer placed, restored HR but had persistent acidosis.
Diagnosis: PRIS- started dialysis. Complete recovery.