The influence of inter-hospital transfers on mortality in severely injured patients.

PURPOSE: The importance of treating severely injured patients in higher-level trauma centers is undisputable. However, it is uncertain whether severely injured patients that were initially transported to a lower-level trauma center (i.e., undertriage) benefit from being transferred to a higher-level trauma center. METHODS: This observational study included all severely injured patients (i.e., Injury Severity Score ≥ 16) that were initially transported to a lower-level trauma center within eight ambulance regions. The exposure of interest was whether a patient was transferred to a higher-level trauma center. Primary outcomes were 24-h and 30-day mortality. Generalized linear models including inverse probability weights for several potential confounders were constructed to evaluate the association between transfer status and mortality. RESULTS: We included 165,404 trauma patients that were transported with high priority to a trauma center, of which 3932 patients were severely injured. 1065 (27.1%) patients were transported to a lower-level trauma center of which 322 (30.2%) were transferred to a higher-level trauma center. Transferring undertriaged patients to a higher-level trauma center was significantly associated with reduced 24-h (relative risk [RR] 0.26, 95%-CI 0.10-0.68) and 30-day mortality (RR 0.65, 0.46-0.92). Similar results were observed in patients with critical injuries (24-h: RR 0.35, 0.16-0.77; 30-day: RR 0.55, 0.37-0.80) and patients with traumatic brain injury (24-h: RR 0.31, 0.11-0.83; 30-day: RR 0.66, 0.46-0.96). CONCLUSIONS: A minority of the undertriaged patients are transferred to a higher-level trauma center. An inter-hospital transfer appears to be safe and may improve the survival of severely injured patients initially transported to a lower-level trauma center.

Impact of the SARS-CoV-2 pandemic on trauma care: a nationwide observational study.

PURPOSE: The SARS-CoV-2 pandemic severely disrupted society and the health care system. In addition to epidemiological changes, little is known about the pandemic's effects on the trauma care chain. Therefore, in addition to epidemiology and aetiology, this study aims to describe the impact of the SARS-CoV-2 pandemic on prehospital times, resource use and outcome. METHODS: A multicentre observational cohort study based on the Dutch Nationwide Trauma Registry was performed. Characteristics, resource usage, and outcomes of trauma patients treated at all trauma-receiving hospitals during the first (W1, March 12 through May 11) and second waves (W2, May 12 through September 23), as well as the interbellum period in between (INT, September 23 through December 31), were compared with those treated from the same periods in 2018 and 2019. RESULTS: The trauma caseload was reduced by 20% during the W1 period and 11% during the W2 period. The median length of stay was significantly shortened for hip fracture and major trauma patients (ISS ≥ 16). A 33% and 66% increase in the prevalence of minor self-harm-related injuries was recorded during the W1 and W2 periods, respectively, and a 36% increase in violence-related injuries was recorded during the INT. Mortality was significantly higher in the W1 (2.9% vs. 2.2%) and W2 (3.2% vs. 2.7%) periods. CONCLUSION: The imposed restrictions in response to the SARS-CoV-2 pandemic led to diminished numbers of acute trauma admissions in the Netherlands. The long-lasting pressing demand for resources, including ICU services, has negatively affected trauma care. Further caution is warranted regarding the increased incidence of injuries related to violence and self-harm.

The impact of prehospital time intervals on mortality in moderately and severely injured patients.

BACKGROUND: Modern trauma systems and emergency medical services aim to reduce prehospital time intervals to achieve optimal outcomes. However, current literature remains inconclusive on the relationship between time to definitive treatment and mortality. The aim of this study was to investigate the association between prehospital time and mortality. METHODS: All moderately and severely injured trauma patients (i.e., patients with an Injury Severity Score of 9 or greater) who were transported from the scene of injury to a trauma center by ground ambulances of the participating emergency medical services between 2015 and 2017 were included. Exposures of interest were total prehospital time, on-scene time, and transport time. Outcomes were 24-hour and 30-day mortality. Generalized linear models including inverse probability weights for several potential confounders were constructed. A generalized additive model was constructed to enable visual inspection of the association. RESULTS: We included 22,525 moderately and severely injured patients. Twenty-four-hour and 30-day mortality were 1.3% and 7.3%, respectively. On-scene time per minute was significantly associated with 24-hour (relative risk [RR], 1.029; 95% confidence interval, 1.018-1.040) and 30-day mortality (RR, 1.013; 1.008-1.017). We found that this association was also present in patients with severe injuries, traumatic brain injury, severe abdominal injury, and stab or gunshot wound. An on-scene time of 20 minutes or longer demonstrated a strong association with 24-hour (RR, 1.797; 1.406-2.296) and 30-day mortality (RR, 1.298; 1.180-1.428). Total prehospital (24-hour: RR, 0.998; 0.990-1.007; 30-day: RR, 1.000, 0.997-1.004) and transport (24-hour: RR, 0.996; 0.982-1.010; 30-day: RR, 0.995; 0.989-1.001) time were not associated with mortality. CONCLUSION: A prolonged on-scene time is associated with mortality in moderately and severely injured patients, which suggests that a reduced on-scene time may be favorable for these patients. In addition, transport time was found not to be associated with mortality. LEVEL OF EVIDENCE: Prognostic and Epidemiologic; level III.

Priority accuracy by dispatch centers and Emergency Medical Services professionals in trauma patients: a cohort study.

PURPOSE: Priority-setting by dispatch centers and Emergency Medical Services professionals has a major impact on pre-hospital triage and times of trauma patients. Patients requiring specialized care benefit from expedited transport to higher-level trauma centers, while transportation of these patients to lower-level trauma centers is associated with higher mortality rates. This study aims to evaluate the accuracy of priority-setting by dispatch centers and Emergency Medical Services professionals. METHODS: This observational study included trauma patients transported from the scene of injury to a trauma center. Priority-setting was evaluated in terms of the proportion of patients requiring specialized trauma care assigned with the highest priority (i.e., sensitivity), undertriage, and overtriage. Patients in need of specialized care were defined by a composite resource-based endpoint. An Injury Severity Score ≥ 16 served as a secondary reference standard. RESULTS: Between January 2015 and December 2017, records of 114,459 trauma patients were collected, of which 3327 (2.9%) patients were in need of specialized care according to the primary reference standard. Dispatch centers and Emergency Medical Services professionals assigned 83.8% and 74.5% of these patients with the highest priority, respectively. Undertriage rates ranged between 22.7 and 65.5% in the different prioritization subgroups. There were differences between dispatch and transport priorities in 17.7% of the patients. CONCLUSION: The majority of patients that required specialized care were assigned with the highest priority by the dispatch centers and Emergency Medical Services professionals. Highly accurate priority criteria could improve the quality of pre-hospital triage.

Evaluating the effect of driving distance to the nearest higher level trauma centre on undertriage: a cohort study.

BACKGROUND: It is of great importance that emergency medical services professionals transport trauma patients in need of specialised care to higher level trauma centres to achieve optimal patient outcomes. Possibly, undertriage is more likely to occur in patients with a longer distance to the nearest higher level trauma centre. This study aims to determine the association between driving distance and undertriage. METHOD: This prospective cohort study was conducted from January 2015 to December 2017. All trauma patients in need of specialised care that were transported to a trauma centre by emergency medical services professionals from eight ambulance regions in the Netherlands were included. Patients with critical resource use or an Injury Severity Score ≥16 were defined as in need of specialised care. Driving distance was calculated between the scene of injury and the nearest higher level trauma centre. Undertriage was defined as transporting a patient in need of specialised care to a lower level trauma centre. Generalised linear models adjusting for confounders were constructed to determine the association between driving distance to the nearest higher level trauma centre per 1 and 10 km and undertriage. A sensitivity analysis was conducted with a generalised linear model including inverse probability weights. RESULTS: 6101 patients, of which 4404 patients with critical resource use and 3760 patients with an Injury Severity Score ≥16, were included. The adjusted generalised linear model demonstrated a significant association between a 1 km (OR 1.04; 95% CI 1.04 to 1.05) and 10 kilometre (OR 1.50; 95% CI 1.42 to 1.58) increase in driving distance and undertriage in patients with critical resource use. Also in patients with an Injury Severity Score ≥16, a significant association between driving distance (1 km (OR 1.06; 95% CI 1.06 to 1.07), 10 km (OR 1.83; 95% CI 1.71 to 1.95)) and undertriage was observed. CONCLUSION: Patients in need of specialised care are less likely to be transported to the appropriate trauma centre with increasing driving distance. Our results suggest that emergency medical services professionals incorporate driving distance into their decision making regarding transport destinations, although distance is not included in the triage protocol.

The impact of the Trauma Triage App on pre-hospital trauma triage: design and protocol of the stepped-wedge, cluster-randomized TESLA trial.

BACKGROUND: Field triage of trauma patients is crucial to get the right patient to the right hospital within a particular time frame. Minimization of undertriage, overtriage, and interhospital transfer rates could substantially reduce mortality rates, life-long disabilities, and costs. Identification of patients in need of specialized trauma care is predominantly based on the judgment of Emergency Medical Services professionals and a pre-hospital triage protocol. The Trauma Triage App is a smartphone application that includes a prediction model to aid Emergency Medical Services professionals in the identification of patients in need of specialized trauma care. The aim of this trial is to assess the impact of this new digital approach to field triage on the primary endpoint undertriage. METHODS: The Trauma triage using Supervised Learning Algorithms (TESLA) trial is a stepped-wedge cluster-randomized controlled trial with eight clusters defined as Emergency Medical Services regions. These clusters are an integral part of five inclusive trauma regions. Injured patients, evaluated on-scene by an Emergency Medical Services professional, suspected of moderate to severe injuries, will be assessed for eligibility. This unidirectional crossover trial will start with a baseline period in which the default pre-hospital triage protocol is used, after which all clusters gradually implement the Trauma Triage App as an add-on to the existing triage protocol. The primary endpoint is undertriage on patient and cluster level and is defined as the transportation of a severely injured patient (Injury Severity Score ≥ 16) to a lower-level trauma center. Secondary endpoints include overtriage, hospital resource use, and a cost-utility analysis. DISCUSSION: The TESLA trial will assess the impact of the Trauma Triage App in clinical practice. This novel approach to field triage will give new and previously undiscovered insights into several isolated components of the diagnostic strategy to get the right trauma patient to the right hospital. The stepped-wedge design allows for within and between cluster comparisons. TRIAL REGISTRATION: Netherlands Trial Register, NTR7243. Registered 30 May 2018, https://www.trialregister.nl/trial/7038.

Long-term Patient-reported Quality of Life and Pain After a Multidisciplinary Clinical Pathway for Elderly Patients With Hip Fracture: A Retrospective Comparative Cohort Study.

INTRODUCTION: There is an increase in incidence of hip fractures in the ageing population. The implementation of multidisciplinary clinical pathways (MCP) has proven to be effective in improving the care for these frail patients, and MCP tends to be more effective than usual care (UC). The aim of this study was to analyze potential differences in patient-reported outcome among elderly patients with hip fractures who followed MCP versus those who followed UC. MATERIALS AND METHODS: This retrospective cohort study included patients aged 65 years or older with a low-energy hip fracture, who underwent surgery in the Maastricht University Medical Center, Maastricht, the Netherlands. Two cohorts were analyzed; the first one had patients who underwent UC in 2012 and the second one contained patients who followed MCP in 2015. Collected data regarded demographics, patient-reported outcomes (Short Form 12 [SF-12] and the Numeric Rating Scale [NRS] to measure pain), and patient outcome. RESULTS: This cohort study included 398 patients, 182 of them were included in the MCP group and 216 were in the UC group. No differences in gender, age, or American Society of Anesthesiologists classification were found between the groups. No significant differences were found in SF-12 and the NRS data between the MCP group and UC group. In the MCP group, significantly lower rates of postoperative complications were found than in the UC group, but mortality within 30 days and one year after the hip fracture was similar in both groups. DISCUSSION: Although the effects of hip fractures in the elderly on patient-reported outcome, pain and quality of life have been addressed in several recent studies, the effects of MCP on long-term outcome was unclear. CONCLUSION: A multidisciplinary clinical pathway approach for elderly patients with a hip fracture is associated with a reduced time to surgery and reduced postoperative complications, while no differences were found in quality of life, pain, or mortality.

Long-term functional outcome after a low-energy hip fracture in elderly patients.

BACKGROUND: The incidence of hip fractures is increasing. Elderly patients with a hip fracture frequently present with comorbidities, which are associated with higher mortality rates. Clinical studies regarding long-term functional outcome and mortality in hip fractures are rare. The aim of this study was to analyse the functional outcome and the mortality rate after a follow-up of 5 years in elderly patients with a hip fracture. MATERIALS AND METHODS: This combined retrospective and cross-sectional study included patients aged 65 years or older with a low energy hip fracture who underwent surgery in the Maastricht University Medical Center+, the Netherlands. Data such as demographics and mortality rates were retrospectively collected and functional outcome (i.e. mobility, pain, housing conditions and quality of life) was assessed by a questionnaire. RESULTS: Two hundred and sixteen patients were included in this study (mean age 82.2, SD ± 7.5). No significant differences were found in pain before hip fracture and after 1-year and 5-year follow-ups. Long-term functional outcome deteriorated after a hip fracture, with a significant increase in the use of walking aids (p < 0.001), a significant decrease of patients living in a private home (p < 0.001), and a low physical quality of life (SF-12 PCS = 27.1). The mortality incidences after 30-day, 1-year and 5-year follow-ups were 7.9%, 37.0% and 69.4%, respectively. CONCLUSION: Long-term functional outcome in elderly patients with hip fractures significantly deteriorated, with an increased dependency for mobility and housing conditions and a decreased physical quality of life. In addition, hip fractures are associated with high mortality rates at the 5-year follow-up. LEVEL OF EVIDENCE: Level III, a retrospective cohort study.

Beware of the force of the horse: mechanisms and severity of equestrian-related injuries.

BACKGROUND: Equestrian-related injuries (ERIs) are relatively severe compared with injuries in other popular sports. Previous studies on epidemiology of ERIs vary widely and mainly focus on incidence instead of severity of the injury. PURPOSE: The aim of this study was to determine incidence, mechanisms and severity of ERIs in two Dutch hospitals (level 1 and level 2 trauma centers) over a 5-year period. PATIENTS AND METHODS: All patients with ERIs who visited the emergency departments of VieCuri Medical Centre in Venlo and Maastricht University Medical Centre+ in Maastricht, The Netherlands, between July 2010 and June 2015 were retrospectively included. Clinical data were extracted from medical records. RESULTS: Most ERIs occurred in mounted riders (646 events; 68%); 94.9% of which involved a fall. Being kicked (42.5%) or trapped (30.1%) was the most common cause of injury in unmounted riders. Most frequently injured body parts were the upper extremities (43.8%) in mounted riders and lower extremities (40.5%) in the unmounted group. A relatively high percentage of facial injuries (9.7%) were found in the unmounted group. Seventeen per cent of all ERIs required admission. The median Injury Severity Score was 5 in the admitted population and 1 in the total population. CONCLUSION: Horseback riding is a risky activity. Prior studies particularly studied admitted patients in level 1 trauma centers outside of Europe and demonstrated a high risk of significant injury. However, our study demonstrates that these studies in selected groups might have overestimated the severity of ERIs in the general population.

Prevalence and Predictors of Patient Nonadherence to Pharmacological Acute Pain Therapy at Home After Day Surgery: A Prospective Cohort Study.

BACKGROUND: Good adherence to prescribed analgesics can be crucial to suppress or even prevent acute postoperative pain after day surgery. The aim of this study was to analyze prevalence and predictors of analgesic nonadherence after day surgery. METHODS: Elective patients scheduled for day surgery were prospectively enrolled from November 2008 to April 2010. Outcome parameters were measured by using questionnaire packages at 2 time points: 1 week preoperatively and 4 days postoperatively. The primary outcome parameter was analgesic nonadherence. Adherence was defined according to the patient's response to the questionnaire item "analgesia use as prescribed": full adherence, "yes"; partial adherence, "yes, sometimes"; nonadherence, "no." Bivariate and multivariate logistic regression analyses were performed to identify predictors of analgesic nonadherence. RESULTS: A total of 1,248 patients were included. The prevalence rates of analgesic nonadherence and partial adherence were 21.6% and 20.0%, respectively, in the total study population but dropped to 9.4% and 19.8%, respectively, in patients with moderate to severe pain. Low postoperative pain intensity and short duration of surgery were the most important predictors of analgesic nonadherence. The most important preoperative predictors for analgesic nonadherence were low preoperative pain intensity, low preoperative expectations of pain, and low fear of short-term effects of surgery. CONCLUSION: Analgesic nonadherence and partial adherence are common after day surgery but decrease as average pain intensity increases. Patients at risk for analgesic nonadherence can be identified during the preoperative period based on preoperative pain intensity, preoperative expectations of pain, and fear of surgery.

Procedure-Specific Pain Intensity Four Days After Day Surgery and the Relationship with Preoperative Pain: A Prospective Cohort Study.

BACKGROUND: Identification of painful procedures is essential for the development of procedure-specific pain-treatment schedules. The aim of this study was firstly, to analyze the prevalence of acute postsurgical pain (APSP) after various types of day surgery on the fourth postoperative day, and secondly, to assess the predictive value of preoperative pain for the development of APSP after different types of surgical procedures. METHODS: From November 2008 to April 2010, patients scheduled for elective day surgery were enrolled in this prospective cohort study. Data were collected one week preoperatively and four days postoperatively. The 11-point Numeric Rating Scale (NRS) was used for pain measurement. Moderate pain was defined as an NRS 4 to 5, and severe pain as an NRS > 5. The predictive value of preoperative pain for development of APSP was analyzed using a univariate logistic regression, stratified for the surgical procedure. RESULTS: From a total of 1123 included patients, 182 patients experienced moderate pain (16.3%) and 136 patients experienced severe pain (12.1%) on the fourth postoperative day. A large procedure-specific variability in APSP was observed, with shoulder, anal and dental surgery associated with the highest pain levels. Overall, preoperative pain significantly predicted postoperative pain on the fourth day (OR 4.45). This predictive value showed a procedure-specific variation and was not noted after various well-defined procedures. CONCLUSIONS: The prevalence of moderate to severe APSP was high four days after day surgery and showed a significant procedure-specific variation. Furthermore, there was a strong relationship between preoperative and postoperative pain, likewise characterized by a significant procedure-specific variation.

External Validation and Modification of a Predictive Model for Acute Postsurgical Pain at Home After Day Surgery.

OBJECTIVES: In 2009, Gramke and colleagues have described predictive factors to preoperatively detect those at risk for moderate to severe acute postsurgical pain (APSP) after day surgery. The aim of the present study is to externally validate this initial model and to improve and internally validate a modified version of this model. MATERIALS AND METHODS: Elective patients scheduled for day surgery were prospectively enrolled from November 2008 to April 2010. Model discrimination was quantified using the area under the receiver operating characteristic curve (AUC). Model calibration was assessed by visual inspection of the calibration plot. Subsequently, we modified (different assignment of type of surgery, different cutoff for moderate to severe APSP, continuous of dichotomized variables and testing of additional variables) and internally validated this model by standard bootstrapping techniques. RESULTS: A total of 1118 patients were included. The AUC for the original model was 0.81 in the derivation data set and 0.72 in our validation data set. The model showed poorly calibrated risk predictions. The AUC of the modified model was 0.82 (optimism-corrected AUC=0.78). This modified model showed good calibration. CONCLUSIONS: The original prediction model of Gramke and colleagues performed insufficiently on our cohort of outpatients with respect to discrimination and calibration. Internal validation of a modified model shows promising results. In this model, preoperative pain, patient derived expected pain, and different types of surgery are the strongest predictors of moderate to severe APSP after day surgery.

Correction: Validation of the Surgical Fear Questionnaire in Adult Patients Waiting for Elective Surgery.

[This corrects the article DOI: 10.1371/journal.pone.0100225.].

Prevalence and Predictive Factors of Chronic Postsurgical Pain and Global Surgical Recovery 1 Year After Outpatient Knee Arthroscopy: A Prospective Cohort Study.

Outpatient knee arthroscopy is one of the most commonly performed surgical procedures. Previous research has demonstrated that chronic postsurgical pain (CPSP) after outpatient surgery is prevalent. Our objective was to determine the prevalence and predictive factors of CPSP and Global Surgical Recovery (GSR) 1 year after knee arthroscopy.A prospective longitudinal cohort study was performed. Patients were included during an 18-month period. Data were collected by using 3 questionnaires: at 1 week preoperatively, 4 days postoperatively, and 1 year postoperatively. A value of >3 on an 11-point numeric rating scale (NRS) was defined as moderate to severe pain. A score of ≤80% on the Global Surgical Recovery Index was defined as poor GSR. Stepwise logistic regression analysis was performed to determine which variables were predictors for CPSP and poor GSR.The prevalence of moderate to severe preoperative pain in patients undergoing knee arthroscopy (n = 104) was 71.2%, of acute postsurgical pain 37.5%, and of CPSP 32.7%. Risk factors for CPSP were the presence of preoperative pain and preoperative analgesic use, with odds ratios of 6.31 (1.25-31.74) and 4.36 (1.58-12.07), respectively. The prevalence of poor GSR 1 year after outpatient knee arthrosocpy was 50.0%. Poor GSR 4 days after the surgery was a risk factor with an odds ratio of 8.38 (0.92-76.58) and quality of life 4 days after surgery was a protective factor with and odds ratio of 0.10 (0.02-0.64).Both CPSP and poor GSR are common 1 year after knee arthroscopy. Patients at risk for CPSP can be identified during the preoperative phase. Prediction of poor GSR 1 year after surgery is mainly related to early postoperative recovery.

Prevalence and Predictors of Quality of Recovery at Home After Day Surgery.

Traditionally, major complications and unanticipated admission/readmission rates were used to assess outcome after day surgery. However, in view of the relative absence of major complications the quality of recovery (QOR) should be considered one of the principal endpoints after day surgery. In our study, the level of QOR is defined by a combination of the Global Surgical Recovery (GSR) Index and the Quality of Life (QOL). The aim of this study was to analyze prevalence and predictors of QOR after day surgery on the fourth postoperative day. Elective patients scheduled for day surgery from November 2008 to April 2010 were enrolled in a prospective cohort study. Outcome parameters were measured by using questionnaire packages at 2 time points: 1 week preoperatively and 4 days postoperatively. Primary outcome parameter is the QOR and is defined as good if the GSR index >80% as well as the postoperative QOL is unchanged or improved as compared with baseline. QOR is defined as poor if both the GSR index ≤ 80% and if the postoperative QOL is decreased as compared with baseline. QOR is defined as intermediate in all other cases. Three logistic regression analyses were performed to determine predictors for poor QOR after day surgery. A total of 1118 patients were included. A good QOR was noted in 17.3% of patients, an intermediate QOR in 34.8%, and a poor QOR in 47.8% 4 days after day surgery. The best predictor for poor QOR after day surgery was type of surgery. Other predictors were younger age, work status, and longer duration of surgery. A history of previous surgery, expected pain (by the patient) and high long-term surgical fear were significant predictors of poor QOR in only 1 of 3 prediction models. The QOR at home 4 days after day surgery was poor in the majority of patients and showed a significant procedure-specific variation. Patients at risk for poor QOR can be identified during the preoperative period based on type of surgery, age, work status, and the duration of the surgery.

Prevalence and Predictive Factors of Chronic Postsurgical Pain and Poor Global Recovery 1 Year After Outpatient Surgery.

OBJECTIVES: To prospectively describe the prevalence and predictive factors of chronic postsurgical pain (CPSP) and poor global recovery in a large outpatient population at a university hospital, 1 year after outpatient surgery. MATERIALS AND METHODS: A prospective longitudinal cohort study was performed. During 18 months, patients presenting for preoperative assessment were invited to participate. Outcome parameters were measured by using questionnaires at 3 timepoints: 1 week preoperatively, 4 days postoperatively, and 1 year postoperatively. A value of >3 on an 11-point numeric rating scale was considered to indicate moderate to severe pain. A score of ≤80% on the Global Surgical Recovery Index was defined as poor global recovery. RESULTS: A total of 908 patients were included. The prevalence of moderate to severe preoperative pain was 37.7%, acute postsurgical pain 26.7%, and CPSP 15.3%. Risk factors for the development of CPSP were surgical specialty, preoperative pain, preoperative analgesic use, acute postoperative pain, surgical fear, lack of optimism, and poor preoperative quality of life. The prevalence of poor global recovery was 22.3%. Risk factors for poor global recovery were recurrent surgery because of the same pathology, preoperative pain, preoperative analgesic use, surgical fear, lack of optimism, poor preoperative and acute postoperative quality of life, and follow-up surgery during the first postoperative year. DISCUSSION: Moderate to severe CPSP after outpatient surgery is common, and should not be underestimated. Patients at risk for developing CPSP can be identified during the preoperative phase.

Controlled-release oxycodone versus naproxen at home after ambulatory surgery: a randomized controlled trial.

BACKGROUND: Strong opioids in the home setting after ambulatory surgery have rarely been studied for fear of hazardous adverse effects such as respiratory depression. OBJECTIVES: We compared the efficacy of paracetamol/controlled-release (CR) oxycodone and paracetamol/naproxen for treatment of acute postoperative pain at home after ambulatory surgery. Secondary outcomes were adverse effects of study medication, treatment satisfaction, and postoperative analgesic compliance. METHODS: Patients undergoing ambulatory knee arthroscopy or inguinal hernia repair surgery (n = 105) were randomized into 3 groups: Group1 paracetamol/naproxen (n = 35), Group 2 paracetamol/CR oxycodone for 24 hours (n = 35), and Group 3 paracetamol/CR oxycodone for 48 hours (n = 35). Pain intensity at movement and at rest using a visual analog scale as well as satisfaction with postoperative analgesia and side effects were recorded for up to 48 hours postoperatively. Compliance with study medication was also assessed. RESULTS: For pain at movement and at rest, no significant differences were found between the paracetamol/naproxen group and either the paracetamol/CR oxycodone for 24 hours group (ß = 2.6 [4.9]; P = 0.597) or the paracetamol/CR oxycodone for 48 hours (ß = -1.7 [5.1]; P = 0.736). No major adverse effects of study medication were registered and satisfaction with postoperative pain treatment was high in all groups. Compliance was comparable across the groups. Despite clear instructions, 8 patients with the lowest pain scores did not use any of the prescribed pain medication. CONCLUSIONS: Paracetamol/CR oxycodone and paracetamol/naproxen are equally effective in treatment of acute postoperative pain at home after ambulatory surgery with comparable patient satisfaction level. We suggest paracetamol/CR oxycodone to be a valuable alternative for the current paracetamol/naproxen gold standard, particularly in patients with a contraindication for nonsteroidal anti-inflammatory drugs. ClinicalTrials.gov identifier: NCT02152592.

Validation of the surgical fear questionnaire in adult patients waiting for elective surgery.

OBJECTIVES: Because existing instruments for assessing surgical fear seem either too general or too limited, the Surgical Fear Questionnaire (SFQ) was developed. The aim of this study is to assess the validity and reliability of the SFQ. METHODS: Based on existing literature and expert consultation the ten-item SFQ was composed. Data on the SFQ were obtained from 5 prospective studies (N = 3233) in inpatient or day surgery patients. These data were used for exploratory factor analysis (EFA), confirmatory factor analysis (CFA), reliability analysis and validity analysis. RESULTS: EFA in Study 1 and 2 revealed a two-factor structure with one factor associated with fear of the short-term consequences of surgery (SFQ-s, item 1-4) and the other factor with fear of the long-term consequences of surgery (SFQ-l, item 5-10). However, in both studies two items of the SFQ-l had low factor loadings. Therefore in Study 3 and 4 the 2-factor structure was tested and confirmed by CFA in an eight-item version of the SFQ. Across all studies significant correlations of the SFQ with pain catastrophizing, state anxiety, and preoperative pain intensity indicated good convergent validity. Internal consistency (Cronbach's alpha) was between 0.765-0.920 (SFQ-total), 0.766-0.877 (SFQ-s), and 0.628-0.899 (SFQ-l). The SFQ proved to be sensitive to detect differences based on age, sex, education level, employment status and preoperative pain intensity. DISCUSSION: The SFQ is a valid and reliable eight-item index of surgical fear consisting of two subscales: fear of the short-term consequences of surgery and fear of the long-term consequences.

Pharmacokinetics and tolerability of nasal versus intravenous midazolam in healthy Dutch volunteers: a single-dose, randomized-sequence, open-label, 2-period crossover pilot study.

BACKGROUND: Intranasal (IN) midazolam is a potential alternative to rectal diazepam for the acute treatment of epileptic seizures. OBJECTIVE: The purpose of this pilot study was to investigate the pharmacokinetics and tolerability of IN midazolam (50 mg/mL) compared with intravenous (IV) midazolam (2.5 mg) in healthy adult volunteers. METHODS: In this single-dose, randomized-sequence, open-label, 2-period crossover pilot study subjects were randomly assigned to receive IN or IV midazolam, with a washout period of at least 5 days between treatments. The 50-mg/mL IN midazolam formulation consisted of 5 mg midazolam base per 0.1 mL (1 spray) and was administered once in 1 nostril. The IV midazolam solution (2.5 mg) was infused over 10 seconds. Blood samples were taken before and at regular intervals up to 240 minutes after dosing. Pharmacokinetic data (ie, C(max), T(max), t(½), and AUC) were analyzed using a 2-compartment model. RESULTS: Of 9 volunteers screened and enrolled, 7 completed the study (mean age 34.1 [9.0] years; mean weight, 68.6 [10.4] kg, range 53-89 kg; 6 men, 3 women; all white). The mean C(max) of 78 (40) ng/mL was reached 44 minutes after IN administration, whereas the mean C(max) was 51 (5) ng/mL after IV administration. The mean estimated C(t=5 min) was 31.4 (28.1) ng/mL after IN administration. The elimination t(½) was 1.9 (0.41) hours for IN midazolam and 2.3 (0.19) hours for IV midazolam. The bioavailability of IN midazolam was 82%. There were few adverse events, with a local burning feeling in the nose being the most reported event (6 of 7 subjects). CONCLUSIONS: In this select group of healthy volunteers, concentrations of midazolam >30 ng/mL were reached within 5 minutes of IN administration at a dose of 5 mg/0.1 mL. A burning feeling in the nostril was the main adverse effect. Additional research is needed to evaluate the safety profile, convenience, satisfaction, and efficacy of nasal midazolam in the treatment of adults with seizures. This trial is registered at www.isrctn.org, No. ISRCTN79059168.