Trials
-
Randomized Controlled Trial Comparative Study
Lignocaine/phenylephrine nasal spray vs. placebo for the pain and distress of nasogastric tube insertion in children: a study protocol for a randomized controlled trial.
Patients and clinicians consistently rate insertion of a nasogastric tube (NGT) as one of the most painful and distressing emergency department procedures. Despite this, surveys of emergency clinicians suggest that provision of adequate procedural analgesia is often inconsistent and suboptimal. While many studies have demonstrated the effectiveness of various interventions to reduce pain and distress in adults, there have been few studies in the pediatric population. There are currently no studies comparing the effectiveness of a local anesthetic nasal spray for the prevention of the pain and distress associated with NGT insertion in children. This study aims to compare the analgesic efficacy of a proprietary preparation of lignocaine/phenylephrine nasal spray and placebo for this indication. ⋯ Previous studies on NGT insertion have not focused on the pediatric population. This study aims to establish the effectiveness of a simple intranasal spray of lignocaine/phenylephrine in children undergoing NGT insertion. A positive result of this study would provide evidence of an effective intervention in a procedure considered by many to be very painful and distressing.
-
Randomized Controlled Trial Multicenter Study
The effects of stimulation of the autonomic nervous system via perioperative nutrition on postoperative ileus and anastomotic leakage following colorectal surgery (SANICS II trial): a study protocol for a double-blind randomized controlled trial.
Postoperative ileus and anastomotic leakage are important complications following colorectal surgery associated with short-term morbidity and mortality. Previous experimental and preclinical studies have shown that a short intervention with enriched enteral nutrition dampens inflammation via stimulation of the autonomic nervous system and thereby reduces postoperative ileus. Furthermore, early administration of enteral nutrition reduced anastomotic leakage. This study will investigate the effect of nutritional stimulation of the autonomic nervous system just before, during and early after colorectal surgery on inflammation, postoperative ileus and anastomotic leakage. ⋯ Activation of the autonomic nervous system via perioperative enteral feeding is expected to dampen the local and systemic inflammatory response. Consequently, postoperative ileus will be reduced as well as anastomotic leakage. The present study is the first to investigate the effects of enriched nutrition given shortly before, during and after surgery in a clinical setting.
-
Comparative Study
Empirical evidence for outcome reporting bias in randomized clinical trials of acupuncture: comparison of registered records and subsequent publications.
Outcome reporting bias has received widespread recognition and been considered to pose two threats to the validity of clinical decision making because they overestimate the effect of treatments or distort the results of trials. However, the problem of outcome-reporting bias has not been systematically studied among randomized clinical trials of acupuncture. Our objectives were to evaluate the consistency between the registered records and subsequent publications with respect to outcomes and other data as well as to determine whether outcome-reporting bias favors significant primary outcomes. ⋯ We find that prospective registration for randomized clinical trials on acupuncture is insufficient, selective outcome reporting is prevalent, and the change of primary outcomes is intended to favor statistical significance. These discrepancies in outcome reporting may lead to biased and misleading results of randomized clinical trials on acupuncture. To ensure publication of reliable and unbiased results, further promotion and implementation of trial registration are still needed.
-
Randomized Controlled Trial
A phase II trial for the efficacy of physiotherapy intervention for early-onset hip osteoarthritis: study protocol for a randomised controlled trial.
Early-onset hip osteoarthritis is commonly seen in people undergoing hip arthroscopy and is associated with increased pain, reduced ability to participate in physical activity, reduced quality of life and reduced range of motion and muscle strength. Despite this, the efficacy of non-surgical interventions such as exercise therapies remains unknown. The primary aim is to establish the feasibility of a phase III randomised controlled trial investigating a targeted physiotherapy intervention for people with early-onset hip osteoarthritis. The secondary aims are to determine the size of treatment effects of a physiotherapy intervention, targeted to improve hip joint range and hip-related symptoms in early-onset hip osteoarthritis following hip arthroscopy, compared to a health-education control. ⋯ The findings of this study will provide guidance regarding the feasibility of a full-scale phase III randomised controlled trial, prior to its undertaking.
-
Randomized Controlled Trial
Effectiveness of a computerized drug-monitoring program to detect and prevent adverse drug events and medication non-adherence in outpatient ambulatory care: study protocol of a randomized controlled trial.
Medications are an effective intervention for managing and preventing health problems but their benefit can be undermined by non-adherence or adverse drug events (ADEs). Since these issues may be interconnected, efforts to improve non-adherence should also include reduction of ADEs. We have developed the ISTOP-ADE system (Information Systems-enabled Outreach for Preventing Adverse Drug Events), which enables timely monitoring and managing of ADEs. The objectives of this study are to determine whether the ISTOP-ADE system, compared to routine care, will reduce: a) the probability of discontinuing the use of prognosis-altering medications; b) the probability of a patient experiencing a severe ADE; c) the proportion of patients experiencing ADEs, preventable ADEs and ameliorable ADEs; and d) health services utilization. ⋯ We expect the ISTOP-ADE intervention to be feasible and to improve the quality of patient care through improved medication adherence, reduced ADE duration and reduced number of ADEs resulting in an emergency department or inpatient encounter. This in turn could lower health-care utilization, saving costs and lowering the burden on emergency departments and family practices. The success of ISTOP-ADE would present opportunities to implement this intervention through health systems, health insurance agents and commercial pharmacies.