BMJ open
-
Multicenter Study
The design of a multicentre Canadian surveillance study of sedation safety in the paediatric emergency department.
Procedural sedation and analgesia have become standard practice in paediatric emergency departments worldwide. Although generally regarded as safe, serious adverse events such as bradycardia, asystole, pulmonary aspiration, permanent neurological injury and death have been reported, but their incidence is unknown due to the infrequency of their occurrence and lack of surveillance of sedation safety. To improve our understanding of the safety, comparative effectiveness and variation in care in paediatric procedural sedation, we are establishing a multicentre patient registry with the goal of conducting regular and ongoing surveillance for adverse events in procedural sedation. ⋯ Ethics approval has been obtained from participating sites. Results will be disseminated using a multifaceted knowledge translation strategy by presenting at international conferences, publication in peer-reviewed journals, and through established networks.
-
Randomized Controlled Trial
Study protocol for a randomised, double-blinded, placebo-controlled, clinical trial of S-ketamine for pain treatment in patients with chronic pancreatitis (RESET trial).
Chronic pancreatitis (CP) is an inflammatory disease that causes irreversible damage to pancreatic tissue. Pain is its most prominent symptom. In the absence of pathology suitable for endoscopic or surgical interventions, pain treatment usually includes opioids. However, opioids often have limited efficacy. Moreover, side effects are common and bothersome. Hence, novel approaches to control pain associated with CP are highly desirable. Sensitisation of the central nervous system is reported to play a key role in pain generation and chronification. Fundamental to the process of central sensitisation is abnormal activation of the N-methyl-D-aspartate receptor, which can be antagonised by S-ketamine. The RESET trial is investigating the analgaesic and antihyperalgesic effect of S-ketamine in patients with CP. ⋯ The protocol is approved by the North Denmark Region Committee on Health Research Ethics (N-20130040) and the Danish Health and Medicines Authorities (EudraCT number: 2013-003357-17). The results will be disseminated in peer-reviewed journals and at scientific conferences.
-
Randomized Controlled Trial Comparative Study
Pharmacist-led management of chronic pain in primary care: costs and benefits in a pilot randomised controlled trial.
To explore differences in mean costs (from a UK National Health Service perspective) and effects of pharmacist-led management of chronic pain in primary care evaluated in a pilot randomised controlled trial (RCT), and to estimate optimal sample size for a definitive RCT. ⋯ Compared with TAU, pharmacist-led interventions for chronic pain appear more costly and provide similar QALYs. However, these estimates are imprecise due to the small size of the pilot trial. The EVSI indicates that a larger trial is necessary to obtain more precise estimates of differences in mean effects and costs between treatment groups.
-
Randomized Controlled Trial
The effects of maintenance schedules following pulmonary rehabilitation in patients with chronic obstructive pulmonary disease: a randomised controlled trial.
Pulmonary rehabilitation (PR) provides benefit for patients with chronic obstructive pulmonary disease (COPD) in terms of quality of life (QoL) and exercise capacity; however, the effects diminish over time. Our aim was to evaluate a maintenance programme for patients who had completed PR. ⋯ A maintenance programme of three monthly 2 h sessions does not improve outcomes in patients with COPD after 12 months. We do not recommend that our maintenance programme is adopted. Other methods of sustaining the benefits of PR are required.
-
To assess the feasibility of a novel diagnostic algorithm targeting patients with risk factors for chronic liver disease in a community setting. ⋯ A non-invasive liver investigation algorithm based in a community setting is feasible to implement. Targeting risk factors using a non-invasive biomarker approach identified a substantial number of patients with previously undetected cirrhosis.