Norman Buckley

Induction with sevoflurane-remifentanil is comparable to propofol-fentanyl-rocuronium in PONV after laparoscopic surgery

PurposeTo compare sevoflurane-remifentanil induction and propofol-fentanyl-rocuronium induction with regards to the frequency of moderate to severe postoperative nausea and vomiting (PONV) in the first 24 hr after laparoscopic day surgery.MethodsAfter informed consent, 156 ASA physical status class I to III patients undergoing laparoscopic cholecystectomy or tubal ligation were randomized to either induction with sevoflurane 8%, N2O 67% and iv remifentanil I to 1.5 βg · kg−1 or induction with iv fentanyl 2 to 3 μg · kg−1, propofol 2 mg · kg−1, and rocuronium 0.3 to 0.5 mg · kg−1. All patients received iv ketorolac 0.5 mg · kg−1 at induction and sevoflurane-N2O maintenance anesthesia with rocuronium as needed. PONV was treated with iv ondansetron, droperidol, or dimenhydrinate; postoperative pain was treated with opioid analgesics. Patients were followed for 24 hr with regards to PONV and pain. Intubating conditions, induction and emergence times, time to achieve fast-track discharge criteria, and drug costs were measured.ResultsNo differences were seen between the two groups in their frequencies of 24-hr moderate to severe PONV and postoperative pain, or in their intubating conditions, induction and emergence times, and time to achieve fast-track discharge criteria. Patients undergoing sevoflurane-remifentanil induction received more morphine (11 mg vs 8 mg; P < 0.001) in the postanesthetic care unit. Sevoflurane-remifentanil induction resulted in similar anesthetic and total drug costs for both procedures.ConclusionWe did not demonstrate any difference in PONV pain, or anesthetic/recovery times or costs between the sevoflurane and propofol groups. Sevoflurane-remifentanil induction is a feasible technique for anesthetic induction.RésuméObjectifComparer l’induction avec sévoflurane-rémifentanil ou propofol-fentanyl-rocuronium quant à la fréquence de nausées et vomissements postopératoires (NVPO) de modérés à sévères pendant les 24 premières heures après une opération en chirurgie d’un jour sous laparoscopie.MéthodeAprès avoir accordé leur consentement, 156 patients d’état physique ASA I à III devant subir une cholécystectomie laparoscopique ou une ligature des trompes ont été randomisés pour une induction avec du sévoflurane à 8%, N2O à 67 % et l à 1,5 μg · kg−1 de rémifentanil iv ou une induction iv avec 2 à 3 μg · kg−1 de fentanyl, 2 mg · kg−1 de propofol et 0,3 à 0,5 mg · kg−1 de rocuronium. Tous les patients ont reçu 0,5 mg · kg−1 de kétorolac iv à l’induction et un mélange de sévoflurane-N2O pour le maintien de l’anesthésie, avec rocuronium au besoin. Un traitement iv avec ondansétron, dropéridol ou dimenhydrinate a été donné pour les NVPO et la douleur postopératoire a été soulagée avec des analgésiques opioïdes. Les patients ont été suivis pendant 24 h pour les NVPO et la douleur. Ont été notés: les conditions d’intubation, les temps nécessaires à l’induction et au réveil, le temps d’atteindre les critères de congé de la chirurgie ambulatoire et le coût des médicaments.RésultatsAucune différence intergroupe n’a été enregistrée concernant la fréquence de NVPO de modérés à sévères et la douleur postopératoire pendant 24 h, ou les conditions d’intubation, les temps d’induction et de réveil, de même que le temps nécessaire à l’atteinte des critères de congé. Les patients soumis à une induction avec un mélange de sévoflurane-rémifentanil ont demandé plus de morphine (11 mg vs 8 mg; P < 0,001) en salle de réveil. L’induction avec sévoflurane-rémifentanil a conduit à un usage d’anesthésiques et à un coût total de médicaments similaires pour les deux types d’interventions chirurgicales.ConclusionNous n’avons trouvé aucune différence de NVPO, de douleur ou de temps liés à l’analgésie et à la récupération postopératoires entre les groupes sous sévoflurane ou propofol. Un mélange de sévoflurane-rémifentanil peut servir à l’induction de l’anesthésie.

Empirical comparison of four baseline covariate adjustment methods in analysis of continuous outcomes in randomized controlled trials

Background Although seemingly straightforward, the statistical comparison of a continuous variable in a randomized controlled trial that has both a pre- and posttreatment score presents an interesting challenge for trialists. We present here empirical application of four statistical methods (posttreatment scores with analysis of variance, analysis of covariance, change in scores, and percent change in scores), using data from a randomized controlled trial of postoperative pain in patients following total joint arthroplasty (the Morphine COnsumption in Joint Replacement Patients, With and Without GaBapentin Treatment, a RandomIzed ControlLEd Study [MOBILE] trials). Methods Analysis of covariance (ANCOVA) was used to adjust for baseline measures and to provide an unbiased estimate of the mean group difference of the 1-year postoperative knee flexion scores in knee arthroplasty patients. Robustness tests were done by comparing ANCOVA with three comparative methods: the posttreatment scores, change in scores, and percentage change from baseline. Results All four methods showed similar direction of effect; however, ANCOVA (−3.9; 95% confidence interval [CI]: −9.5, 1.6; P=0.15) and the posttreatment score (−4.3; 95% CI: −9.8, 1.2; P=0.12) method provided the highest precision of estimate compared with the change score (−3.0; 95% CI: −9.9, 3.8; P=0.38) and percent change (−0.019; 95% CI: −0.087, 0.050; P=0.58). Conclusion ANCOVA, through both simulation and empirical studies, provides the best statistical estimation for analyzing continuous outcomes requiring covariate adjustment. Our empirical findings support the use of ANCOVA as an optimal method in both design and analysis of trials with a continuous primary outcome.

Systematic Review: Audiovisual Interventions for Reducing Preoperative Anxiety in Children Undergoing Elective Surgery

OBJECTIVE To examine the effectiveness of Audiovisual (AV) interventions at reducing preoperative anxiety and its associated outcomes in children undergoing elective surgery. METHODS A systematic review of randomized controlled trials (RCTs) and nonrandomized studies where the primary outcome was childrens preoperative anxiety was conducted. Secondary outcomes included postoperative pain, behavioral changes, recovery, induction compliance, satisfaction, and cost-effectiveness. The risk of bias of each study was assessed. RESULTS In all, 18 studies were identified. A meta-analytic approach and narrative synthesis of findings were used to summarize the results of the studies. CONCLUSIONS This systematic review suggests that AV interventions can be effective in reducing childrens preoperative anxiety. Videos, multi-faceted programs, and interactive games appear to be most effective, whereas music therapy and Internet programs are less effective. While AV interventions appear potentially useful, adequately powered RCTs are required to conclusively pinpoint the components and mechanisms of the most effective AV interventions and guide practice.

Pediatric oncology sedation trial (POST): A double-blind randomized study.

There is limited evidence to support the use of an anti‐emetic with the administration of intra‐thecal chemotherapy. Nor is there adequate clarity on analgesic strategies for children with cancer undergoing painful procedures.

“Push” versus “Pull” for mobilizing pain evidence into practice across different health professions: A protocol for a randomized trial

BackgroundOptimizing pain care requires ready access and use of best evidence within and across different disciplines and settings. The purpose of this randomized trial is to determine whether a technology-based “push” of new, high-quality pain research to physicians, nurses, and rehabilitation and psychology professionals results in better knowledge and clinical decision making around pain, when offered in addition to traditional “pull” evidence technology. A secondary objective is to identify disciplinary variations in response to evidence and differences in the patterns of accessing research evidence.MethodsPhysicians, nurses, occupational/physical therapists, and psychologists (n = 670) will be randomly allocated in a crossover design to receive a pain evidence resource in one of two different ways. Evidence is extracted from medical, nursing, psychology, and rehabilitation journals; appraised for quality/relevance; and sent out (PUSHed) to clinicians by email alerts or available for searches of the accumulated database (PULL). Participants are allocated to either PULL or PUSH + PULL in a randomized crossover design. The PULL intervention has a similar interface but does not send alerts; clinicians can only go to the site and enter search terms to retrieve evidence from the cumulative and continuously updated online database. Upon entry to the trial, there is three months of access to PULL, then random allocation. After six months, crossover takes place. The study ends with a final three months of access to PUSH + PULL. The primary outcomes are uptake and application of evidence. Uptake will be determined by embedded tracking of what research is accessed during use of the intervention. A random subset of 30 participants/ discipline will undergo chart-stimulated recall to assess the nature and depth of evidence utilization in actual case management at baseline and 9 months. A different random subset of 30 participants/ discipline will be tested for their skills in accessing evidence using a standardized simulation test (final 3 months). Secondary outcomes include usage and self-reported evidence-based practice attitudes and behaviors measured at baseline, 3, 9, 15 and 18 months.DiscussionThe trial will inform our understanding of information preferences and behaviors across disciplines/practice settings. If this intervention is effective, sustained support will be sought from professional/health system initiatives with an interest in optimizing pain management.Trial registrationRegistered as NCT01348802 on clinicaltrials.gov.

Reanalysis of morphine consumption from two randomized controlled trials of gabapentin using longitudinal statistical methods

Background Postoperative pain management in total joint replacement surgery remains ineffective in up to 50% of patients and has an overwhelming impact in terms of patient well-being and health care burden. We present here an empirical analysis of two randomized controlled trials assessing whether addition of gabapentin to a multimodal perioperative analgesia regimen can reduce morphine consumption or improve analgesia for patients following total joint arthroplasty (the MOBILE trials). Methods Morphine consumption, measured for four time periods in patients undergoing total hip or total knee arthroplasty, was analyzed using a linear mixed-effects model to provide a longitudinal estimate of the treatment effect. Repeated-measures analysis of variance and generalized estimating equations were used in a sensitivity analysis to compare the robustness of the methods. Results There was no statistically significant difference in morphine consumption between the treatment group and a control group (mean effect size estimate 1.0, 95% confidence interval −4.7, 6.7, P=0.73). The results remained robust across different longitudinal methods. Conclusion The results of the current reanalysis of morphine consumption align with those of the MOBILE trials. Gabapentin did not significantly reduce morphine consumption in patients undergoing major replacement surgeries. The results remain consistent across longitudinal methods. More work in the area of postoperative pain is required to provide adequate management for this patient population.

Hamilton acute pain service safety study: using root cause analysis to reduce the incidence of adverse events.

Background:Although intravenous patient-controlled analgesia opioids and epidural analgesia offer improved analgesia for postoperative patients treated on an acute pain service, these modalities also expose patients to some risk of serious morbidity and even mortality. Root cause analysis, a process for identifying the causal factor(s) that underlie an adverse event, has the potential to identify and address system issues and thereby decrease the chance of recurrence of these complications. Methods:This study was designed to compare the incidence of adverse events on an acute pain service in three hospitals, before and after the introduction of a formal root cause analysis process. The “before” cohort included all patients with pain from February 2002 to July 2007. The “after” cohort included all patients with pain from January 2009 to December 2009. Results:A total of 35,384 patients were tracked over the 7 yr of this study. The after cohort showed significant reductions in the overall event rate (1.47 vs. 2.35% or 1 in 68 vs. 1 in 42, the rate of respiratory depression (0.41 vs. 0.71%), the rate of severe hypotension (0.78 vs. 1.34%), and the rate of patient-controlled analgesia pump programming errors (0.0 vs. 0.08%). Associated with these results, the incidence of severe pain increased from 6.5 to 10.5%. To achieve these results, 26 unique recommendations were made of which 23 being completed, 1 in progress, and 2 not completed. Conclusions:Formal root cause analysis was associated with an improvement in the safety of patients on a pain service. The process was effective in giving credibility to recommendations, but addressing all the action plans proved difficult with available resources.

Opioids for chronic non-cancer pain: a protocol for a systematic review of randomized controlled trials

BackgroundOpioids are prescribed frequently and increasingly for the management of chronic non-cancer pain (CNCP). Current systematic reviews have a number of limitations, leaving uncertainty with regard to the benefits and harms associated with opioid therapy for CNCP. We propose to conduct a systematic review and meta-analysis to summarize the evidence for using opioids in the treatment of CNCP and the risk of associated adverse events.Methods and designEligible trials will include those that randomly allocate patients with CNCP to treatment with any opioid or any non-opioid control group. We will use the guidelines published by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) to inform the outcomes that we collect and present. We will use the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system to evaluate confidence in the evidence on an outcome-by-outcome basis. Teams of reviewers will independently and in duplicate assess trial eligibility, abstract data, and assess risk of bias among eligible trials. To ensure interpretability of our results, we will present risk differences and measures of relative effect for all outcomes reported and these will be based on anchor-based minimally important clinical differences, when available. We will conduct a priori defined subgroup analyses consistent with current best practices.DiscussionOur review will evaluate both the effectiveness and the adverse events associated with opioid use for CNCP, evaluate confidence in the evidence using the GRADE approach, and prioritize patient-important outcomes with a focus on functional gains guided by IMMPACT recommendations. Our results will facilitate evidence-based management of patients with CNCP and identify key areas for future research.Systematic review registrationOur protocol is registered on PROSPERO (CRD42012003023), http://www.crd.york.ac.uk/PROSPERO.

Regional vs general anaesthesia in orthopaedics

ConclusionIt becomes difficult to develop a cogent argument (from the literature regarding patient outcome) for regional anaesthesia in preference to general anaesthesia for orthopaedic surgery. For deep venous thrombosis, it may be that the attendant medical care of the patient should be altered rather than the anaesthetic technique. Advantages of regional anaesthesia may be short-lived, and overwhelmed by the myriad of other factors coming into play, as with blood loss and perioperative delirium. Even nausea and vomiting are not clearly reduced by the use of the techniques. The persistence of the belief in the superiority of regional anaesthesia may represent a case of our unwillingness to “abandon a perfectly good theory simply because it is wrong,” or it may be that we simply have not asked the appropriate question to elucidate a common impression. This latter remains a challenge.ConclusionIl apparaît difficile de produire un argument convaincant (à partir de la littérature faisant état du pronostic à long terme) qui favoriserait l’anesthésie régionale sur la générale en chirurgie orthopédique. En ce qui concerne la thrombose veineuse profonde, c’est l’attention médicale portée au patient qui doit être modifiée plutôt que la technique anesthésique. Les avantages de l’anesthésie régionale pourraient ne pas faire long feu et subir l’inondation de la multitude des autres facteurs reconnus, aussi bien en ce qui concerne la perte sanguine que le délire postopératoire. Même les nausées et vomissements ne sont pas réduits de façon évidente par l’usage des techniques régionales. La persistence de cette prétendue supériorité de l’anesthésie régjonale peut refléter le dicton qui énonce que les mythes ont la vie dure, ou encore résulter du fait qu’on ne s’est pas encore posé les bonnes questions qui nous permettraient d’élucider une impression clinique répandue. La dernière question demeure un défi.

Tablet-based Intervention for Reducing Children's Preoperative Anxiety: A Pilot Study

Objectives: To examine the feasibility, acceptability, and effects of a novel tablet-based application, Story-Telling Medicine (STM), in reducing childrens preoperative anxiety. Methods: Children (N = 100) aged 7 to 13 years who were undergoing outpatient surgery were recruited from a local childrens hospital. This study comprised 3 waves: Waves 1 (n = 30) and 2 (n = 30) examined feasibility, and Wave 3 (n = 40) examined the acceptability of STM and compared its effect on preoperative anxiety to Usual Care (UC). In Wave 3, children were randomly allocated to receive STM+UC or UC. A change in preoperative anxiety was measured using the Childrens Perioperative Multidimensional Anxiety Scale (CPMAS) 7 to 14 days before surgery (T1), on the day of surgery (T2), and 1 month postoperatively (T3). Results: Wave 1 demonstrated the feasibility of participant recruitment and data collection procedures but identified challenges with attrition at T2 and T3. Wave 2 piloted a modified protocol that addressed attrition and increased the feasibility of follow-up. In Wave 3, children in the STM+UC demonstrated greater reductions in CPMAS compared with the UC group (&Dgr;M = 119.90, SE = 46.36, t(27) = 2.59, p = .015; 95% confidence interval = 24.78–215.02). Conclusion: This pilot study provides preliminary evidence that STM is a feasible and acceptable intervention for reducing childrens preoperative anxiety in a busy pediatric operative setting and supports the investigation of a full-scale randomized controlled trial.