Serious Adverse Events after a Single Shot of Intrathecal Morphine: A Case Series and Systematic Review.

Background: The dose of intrathecal morphine is important because of its narrow therapeutic range. Due to a compounding error, pharmacy-compounded, ready-to-use syringes contained 1 mg ml-1 morphine instead of the intended 50 mcg ml-1. Six patients consequently received this twenty-fold dose. This study aims to describe the serious adverse events in these six patients and a systematic review is added to describe the characteristics of serious adverse events after intrathecal morphine. Methods: A retrospective case series described all six patients that received the erroneous morphine intrathecally for analgesia after laparoscopic segmental colonic resections. The patients' charts were reviewed for the occurrence, timing, duration and management of adverse events, the vital signs at the night after surgery, and length of hospital stay. A systematic review investigated characteristics of serious adverse events after intrathecal morphine in a perioperative setting. Results: Four patients had a serious adverse event, which was respiratory depression combined with somnolence (n = 3) and hypotension (n = 1). The review yielded 63 cases with serious adverse events, predominantly somnolence and/or respiratory depression. The onset occurred between 2 and 24 hours after injection. The severity of symptoms varied and life-threatening respiratory depression only occurred after a dose >900 mcg or when potentiating medication was used. Naloxone did not affect analgesia. No prolonged sequalae occurred. Conclusion: This study reveals that respiratory depression and somnolence are the predominant serious adverse events after intrathecal morphine in a perioperative setting and demonstrated a large variation in the presentation of symptoms.

Nurses versus physician-led interhospital critical care transport: a randomized non-inferiority trial.

PURPOSE: Regionalization and concentration of critical care increases the need for interhospital transport. However, optimal staffing of ground critical care transport has not been evaluated. METHODS: In this prospective, randomized, open-label, blinded-endpoint non-inferiority trial, critically ill patients on mechanical ventilation transported by interhospital ground critical care transport were randomized between transport staffed by a dedicated team comprising a critical care nurse and paramedic (nurses group) or a dedicated team including a critical care physician (nurses + physician group). The primary outcome was the number of patients with critical events, both clinical and technical, during transport. Clinical events included decrease in blood pressure, oxygen saturation, or temperature, blood loss, new cardiac arrhythmias, or death. Non-inferiority was assumed if the upper limit of the two-sided 90 % confidence interval (CI) for the between-group difference lies below the non-inferiority margin of 3 %. RESULTS: Of 618 eligible transported critically ill patients, 298 could be analyzed after randomization and allocation to the nurses group (n = 147) or nurses + physician group (n = 151). The percentages of patients with critical events were 16.3 % (24 incidents in 147 transports) in the nurses group and 15.2 % (23 incidents in 151 transports) in the nurses + physician group (difference 1.1 %, two-sided 90 % CI [-5.9 to 8.1]). Critical events occurred in both groups at a higher than the expected (0-1 %) rate. In the nurses group consultations for physician assistance were requested in 8.2 % (12 in 147 transports), all of which were performed prior to transport. CONCLUSIONS: The number of patients with critical events did not markedly differ between critical care transports staffed by a critical care nurse and paramedic compared to a team including a critical care physician. However, as a result of an unexpected higher rate of critical events in both groups recorded by an electronic health record, non-inferiority of nurse-led interhospital critical transport could not be established ( http://www.controlled-trials.com/ISRCTN39701540 ).