Objective: To determine the cause of unexplained postoperative adult r
espiratory distress syndrome (ARDS). Design: Case-control study of pos
toperative ARDS. Setting: Intensive care unit (ICU) of a Veterans Affa
irs hospital. Patients: Six postoperative patients recovering from unc
omplicated vascular or cardiothoracic surgery developed unexplained AR
DS. Controls were 17 patients having similar procedures without the de
velopment of ARDS. Intervention: Infusion of fentanyl with a tamper-pr
oof device. Measurements and Main Results: Development of ARDS. ARDS b
egan 1 to 4 days after surgery, was characterized by maximum alveolar-
arterial oxygen gradient that ranged from 232 to 544 torr (30.9 to 72.
5 kPa), and was associated with death of two patients. We observed no
association with patient location before ARDS onset, nonanalgesic medi
cation administered, staff assignment, or mode of respiratory therapy.
All six patients who developed unexplained ARDS had received epidural
fentanyl compared with none of 17 control patients without ARDS (p =
.0002), We instituted a tamper-proof mode of parenteral fentanyl admin
istration, and subsequently observed one case of ARDS in 26 consecutiv
e surgical patients (p = .000014). Conclusions: Based on these finding
s, as well as a prior history of fentanyl theft at our institution, we
conclude that tampering with fentanyl infusate was responsible for th
e ARDS epidemic that we observed.