ASA Study of Damage Claims Sheds Light on Safety
Pain practitioners using implantable drug-delivery systems (IDDS) should exercise greater caution to prevent medication errors and to detect the earliest signs of progressive neurologic deterioration, according to a newly released study by the American Society of Anesthesiology Closed Claims Project.
Due to an increase in implantable device-related anesthesia pain medicine claims, the authors investigated anesthesia liability associated with these devices as part of the Closed Claims Project's continuing effort to shed light on patterns that can improve patient safety.
Half of pain medicine claims for damages related to IDDS maintenance were associated with death or permanent severe injury, most commonly from medication errors or failure to recognize progressive neurologic deterioration.
"Practitioners implanting or managing devices for chronic pain should exercise caution in these areas to minimize patient harm," the authors wrote.
The study was led by Dermot R. Fitzgibbon, MD, and colleagues. The authors identified 148 pain medicine device claims from 1990 or later in the Anesthesia Closed Claims Project Database. Device-related damaging events included medication administration events, infections, hematomas, retained catheter fragments, cerebrospinal fluid leaks, cord or cauda equina trauma, device placed at wrong level, stimulator incorrectly programmed, delay in recognition of granuloma formation, and other issues.
The most common devices were IIDDS (64%) and spinal cord stimulators (29%). Device-related care consisted of surgical device procedures (n = 107) and IDDS maintenance (n = 41).
Severity of injury was greater in IDDS maintenance claims (56% death or severe permanent injury) versus surgical device procedures (26%, p < 0.001).
Death and brain damage in IDDS maintenance claims resulted from medication administration errors (n = 13; 32%); spinal cord injury resulted from delayed recognition of granuloma formation (n = 9; 22%). The most common damaging events for surgical device procedures were infections, inadequate pain relief, cord trauma, retained catheter fragments, and subcutaneous hygroma. Care was more commonly assessed as less than appropriate (78%) and payments more common (63%) in IDDS maintenance than in surgical device procedure claims (p < 0.001). (See: Fitzgibbon DR, Stephens LS, Posner KL, et al. Injury and liability associated with implantable devices for chronic pain. Anesthesiology. 2016;124: Apr 7 [epub ahead of print].)
Combined Studies of IV Acetaminophen in the ED Promising Despite Limitations
An analysis and review of 14 randomized controlled trials (RCTs), each with various methodological flaws, provides some limited evidence to support the use of intravenous acetaminophen (IV APAP) as a primary analgesic for acute pain control for patients in the emergency room setting.
IV APAP has been widely used in Europe for more than 20 years and was approved by the FDA in 2010. The authors of the evidence-based review wrote that emerging literature suggesting use of IV APAP for pain reduction in the emergency department (ED) prompted them to examine the evidence.
The authors searched MEDLINE and EMBASE databases and included RCTs that described or evaluated the use of IV APAP for acute pain in the ED. The primary outcome was the difference in pain score between IV APAP and active comparator or placebo from baseline to a cutoff time specified in the original trials. Secondary outcome measures were incidence of adverse events and reduction in the amount of adjuvant analgesics consumed by patients who received IV APAP.
The resulting 14 RCTs that met the authors' inclusion criteria enrolled a total of 1472 patients. The level of evidence for the individual trials ranged from very low to moderate, and each had some methodological flaws.
In 3 of the 14 trials, a significant reduction in pain scores was observed in patients who received IV APAP. One trial demonstrated a significant reduction in mean pain scores when IV APAP was compared to IV morphine at 30 minutes after drug administration (4.7 +/- 2.3 vs. 2.9 +/- 2.2). In another trial, patients who received IV APAP reported lower pain scores (31.7 mm + 18, 95% CI, 8.2-25.2) compared with those who received IV morphine (48.3 mm + 14.1, 95% CI, 8.2-25.2), 15 minutes after drug administration. A third trial found a significant reduction (P = 0.005) in mean pain scores when IV APAP was compared with IM piroxicam 90 minutes after drug administration.
In the remaining 8 trials, however, pain scores were not statistically different for IV APAP versus other pain medications.
The authors noted that the incidence of adverse effects associated with IV APAP was low. With some evidence indicating this comparatively low-risk drug could be helpful in the ED and reduce the need for morphine, it is worth further investigation using better methodology. (See: Sin B, Wai M, Tatunchak T, et al. The use of intravenous acetaminophen for acute pain in the emergency department. Acad Emerg Med. 2016 Jan 29. doi: 0.1111/acem.12921. PMID: 26824905.)