17 research outputs found
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Update to the effectiveness and cost-effectiveness of a mindfulness training programme in schools compared with normal school provision (MYRIAD): study protocol for a randomised controlled trial
Abstract: Background: MYRIAD (My Resilience in Adolescence) is a superiority, parallel group, cluster randomised controlled trial designed to examine the effectiveness and cost-effectiveness of a mindfulness training (MT) programme, compared with normal social and emotional learning (SEL) school provision to enhance mental health, social-emotional-behavioural functioning and well-being in adolescence. The original trial protocol was published in Trials (accessible at https://doi.org/10.1186/s13063-017-1917-4). This included recruitment in two cohorts, enabling the learning from the smaller first cohort to be incorporated in the second cohort. Here we describe final amendments to the study protocol and discuss their underlying rationale. Methods: Four major changes were introduced into the study protocol: (1) there were changes in eligibility criteria, including a clearer operational definition to assess the degree of SEL implementation in schools, and also new criteria to avoid experimental contamination; (2) the number of schools and pupils that had to be recruited was increased based on what we learned in the first cohort; (3) some changes were made to the secondary outcome measures to improve their validity and ability to measure constructs of interest and to reduce the burden on school staff; and (4) the current Coronavirus Disease 2019 (SARS-CoV-2 or COVID-19) pandemic both influences and makes it difficult to interpret the 2-year follow-up primary endpoint results, so we changed our primary endpoint to 1-year follow-up. Discussion: These changes to the study protocol were approved by the Trial Management Group, Trial Steering Committee and Data and Ethics Monitoring Committees and improved the enrolment of participants and quality of measures. Furthermore, the change in the primary endpoint will give a more reliable answer to our primary question because it was collected prior to the COVID-19 pandemic in both cohort 1 and cohort 2. Nevertheless, the longer 2-year follow-up data will still be acquired, although this time-point will be now framed as a second major investigation to answer some new important questions presented by the combination of the pandemic and our study design. Trial registration: International Standard Randomised Controlled Trials ISRCTN86619085. Registered on 3 June 2016
Comparative safety of serotonin (5-HT3) receptor antagonists in patients undergoing surgery: a systematic review and network meta-analysis
Regularly Scheduled Oral Morphine for Post Surgical Orthopedic Pain
ABSTRACTPost-surgical pain (PSP) is often poorly controlled despite the availability of many effective narcotic analgesics. Poor analgesia may be due to the use of inappropriate doses and dosing intervals rather than the type of analgesic agent used. Oral morphine administered on a regular schedule is a very effective therapy in patients with chronic pain but has not been actively investigated in the treatment of acute post-surgical pain in adults.We studied the use of regularly scheduled oral morphine given every four hours in 13 patients undergoing total hip arthroplasty. This was an open pilot study to determine if regularly dosed oral morphine was effective and safe in this patient population. All patients initially received 20 mg PO q4h regularly dosed oral morphine with an option to receive 10 mg PO morphine PRN for pain. Eleven of 13 patients completed the study and received oral morphine for an average of 48 hours. Of the two patients who did not complete the study, one withdrew due to inadequate pain control and one withdrew due to upper gastrointestinal discomfort. None of the 11 patients completing the study required any parenteral morphine for breakthrough pain, and only three patients requested additional doses of oral morphine. Vomiting occurred in six of the study patients. lt appears that regularly dosed oral morphine may be an effective means of administering narcotics to postsurgical orthopedic patients and should be compared in clinical trials to other methods of narcotic delivery.RÉSUMÉLes douleurs post-chirurgicales (DPS) sont souvent mal contrôlées, malgré la disponibilité d'un grand nombre d'analgésiques narcotiques efficaces. Il est possible que les problèmes d'analgésie résultent plus d'une posologie et/ou d'intervalles entre les doses inadéquates que du choix de l'analgésique. L'administration de morphine par voie orale à intervalles réguliers donne de bons résultats chez les patients qui éprouvent des douleurs chroniques, mais cette possibilité n'a pas été examinée pour les douleurs post-chirurgicales aiguës chez l'adulte.Les auteurs se sont penchés sur l'administration de morphine par voie orale à l’intervalles réguliers, soit aux quatre heures, chez  13 patients ayant subi une arthroplastie complète de la hanche. L'étude pilote libre devait déterminer l’efficacité et l'innocuité de l'administration régulière d'une dose de morphhine par voie orale à cette population. Chaque patient a reçu au départ 20 mg po q4h de morphine par voie orale sur une base régulière. Les patients pouvaient en outre obtenir 10 mg po de morphine prn pour combattre la douleur. Onze des treize sujets ont complétés l'étude et reçu de la morphine par voie orale pendant 48 heures en moyenne. Un des deux patients qui ont abandonné le projet a donné comme raison un mauvais contrôle de la douleur tandis que le second a mentionné des malaises dans la partie supérieure du système gastro-intestinal. Aucun des onze patients qui ont complété l'étude n'a eu besoin de morphine parentérale pour combattre la douleur et seuls trois d'entre eux ont réclamé des comprimés supplémentaires. Six on souffert de vomissements. Il semble que l'administration de morphine en doses régulières par voie orale s'avère efficace chez les patients qui subissent une intervention chirurgicale orthopédique et cette méthode devrait être comparée à d'autres techniques d'administration des narcotiques dans le cadre d’essais cliniques
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Reversal of profound neuromuscular block by sugammadex administered three minutes after rocuronium: a comparison with spontaneous recovery from succinylcholine
Rocuronium in intubation doses provides similar intubation conditions as succinylcholine, but has a longer duration of action. This study compared time to sugammadex reversal of profound rocuronium-induced neuromuscular block with time to spontaneous recovery from succinylcholine.
One hundred and fifteen adult American Society of Anesthesiologists Class I-II surgical patients were randomized to this multicenter, safety-assessor-blinded, parallel group, active-controlled, Phase IIIa trial. Anesthesia was induced and maintained with propofol and an opioid. Neuromuscular transmission was blocked and tracheal intubation facilitated with 1.2 mg/kg rocuronium or 1 mg/kg succinylcholine. Sugammadex (16 mg/kg) was administered 3 min after rocuronium administration. Neuromuscular function was monitored by acceleromyography. The primary efficacy endpoint was the time from the start of relaxant administration to recovery of the first train-of-four twitch (T(1)) to 10%.
One hundred and ten patients received study treatment. Mean times to recovery of (T(1)) to 10% and (T(1)) to 90% were significantly faster in the rocuronium-sugammadex group (4.4 and 6.2 min, respectively), as compared with the succinylcholine group (7.1 and 10.9 min, respectively; all P < 0.001). Timed from sugammadex administration, the mean time to recovery of (T(1)) to 10%, (T(1)) to 90%, and the train-of-four (T(4)/T(1)) ratio to 0.9 was 1.2, 2.9, and 2.2 min, respectively. Reoccurrence of the block was not observed. There were no serious adverse events related to study treatments.
Reversal of profound high-dose rocuronium-induced neuromuscular block (1.2 mg/kg) with 16 mg/kg sugammadex was significantly faster than spontaneous recovery from 1 mg/kg succinylcholine