Trials
-
Randomized Controlled Trial
Use of dexmedetomidine for prophylactic analgesia and sedation in delayed extubation patients after craniotomy: a study protocol and statistical analysis plan for a randomized controlled trial.
Pain and agitation are common in patients after craniotomy. They can result in tachycardia, hypertension, immunosuppression, increased catecholamine production and increased oxygen consumption. Dexmedetomidine, an alpha-2 agonist, provides adequate sedation without respiratory depression, while facilitating frequent neurological evaluation. ⋯ The study has been initiated as planned in July 2012. One interim analysis advised continuation of the trial. The study will be completed in July 2013.
-
Randomized Controlled Trial Comparative Study
Three-dimensional evaluation of postoperative swelling in treatment of zygomatic bone fractures using two different cooling therapy methods: a randomized, observer-blind, prospective study.
Surgical treatment and complications in patients with zygomatic bone fractures can lead to a significant degree of tissue trauma resulting in common postoperative symptoms and types of pain, facial swelling and functional impairment. Beneficial effects of local cold treatment on postoperative swelling, edema, pain, inflammation, and hemorrhage, as well as the reduction of metabolism, bleeding and hematomas, have been described.The aim of this study was to compare postoperative cooling therapy applied through the use of cooling compresses with the water-circulating cooling face mask manufactured by Hilotherm in terms of beneficial impact on postoperative facial swelling, pain, eye motility, diplopia, neurological complaints and patient satisfaction. ⋯ Hilotherapy is more efficient in managing postoperative swelling and pain after treatment of unilateral zygomatic bone fractures than conventional cooling.
-
Randomized Controlled Trial
PACE--the first placebo controlled trial of paracetamol for acute low back pain: statistical analysis plan.
Paracetamol (acetaminophen) is recommended in most clinical practice guidelines as the first choice of treatment for low back pain, however there is limited evidence to support this recommendation. The PACE trial is the first placebo controlled trial of paracetamol for acute low back pain. This article describes the statistical analysis plan. ⋯ A standard analysis plan was developed for the results of the PACE study. This plan comprehensively describes the data captured and pre-determined statistical tests of relevant outcome measures. The plan demonstrates transparent and verifiable use of the data collected. This a priori plan will be followed to ensure rigorous standards of data analysis are strictly adhered to.
-
Randomized Controlled Trial Comparative Study
Effect of variations in depth of neuromuscular blockade on rating of surgical conditions by surgeon and anesthesiologist in patients undergoing laparoscopic renal or prostatic surgery (BLISS trial): study protocol for a randomized controlled trial.
Surgical conditions in laparoscopic surgery are largely determined by the depth of neuromuscular relaxation. Especially in procedures that are confined to a narrow working field, such as retroperitoneal laparoscopic surgery, deep neuromuscular relaxation may be beneficial. Until recently, though, deep neuromuscular block (NMB) came at the expense of a variety of issues that conflicted with its use. However, with the introduction of sugammadex, rapid reversal of a deep NMB is feasible. In the current protocol, the association between the depth of NMB and rating of surgical conditions by the surgeon and anesthesiologist is studied. ⋯ We aim to show that under the right conditions the perceived opposing goals of surgeons and anesthesiologists (optimal surgical conditions vs. optimal postoperative conditions) may be met without compromise to either.
-
Randomized Controlled Trial
A self-management program for employees with complaints of the arm, neck, or shoulder (CANS): study protocol for a randomized controlled trial.
Complaints of the arm, neck, or shoulder (CANS) have a multifactorial origin and cause considerable work problems, including decreased work productivity, sickness absence, and, ultimately, job loss. There is a need for intervention programs for people with CANS. Self-management is an approach used in chronic disease care to improve self-efficacy and wellness behaviors to facilitate participants to make informed choices and carry them out. This study will evaluate the effectiveness of a self-management program (including ehealth) and compare it to usual care among employees with chronic CANS (lasting >3 months). ⋯ Following the process of intervention mapping we developed a self-management program to suit and alleviate the problems and needs of employees with CANS. A strength of the study is that our intervention is specifically tailored to match the needs of employees with CANS. The study also has some potential weaknesses (for example, use of co-interventions, combination of group sessions and ehealth, self-reporting of data and possible contamination, Hawthorne effect, and recall or information bias) which are discussed.