Risultati per: Short Acting Opioid

Introduction
Nociception monitoring has recently gained recognition as a valuable tool for guiding intraoperative opioid administration. Several nociception monitors, including the Surgical Pleth Index, the Index of Consciousness (IoC) and the Nociception Level, have been introduced for managing intraoperative analgesia. While these technologies show promise in initial applications, the effectiveness of IoC2 in guiding pain management during anaesthesia, particularly in elderly patients who require precise opioid use, remains unclear. This study aims to evaluate the effectiveness of IoC2 in guiding intraoperative opioid use in elderly patients.

Methods and analysis
We will conduct a prospective, randomised, controlled, single-blind, single-centre study with recruitment carried out from 1 February to 30 November 2025. Patients will be randomly assigned to either the IoC2 group or the control group. In the IoC2 group, sufentanil dosing will be guided by intraoperative IoC2 measurements, while in the control group, it will be guided by haemodynamic parameters. The primary outcome will be to compare intraoperative sufentanil consumption between the two groups to assess the potential role of IoC2 in optimising perioperative analgesia in elderly patients.

Ethics and dissemination
This study has been approved by the ethics committee of China-Japan Friendship Hospital (2024-KY-148-3) and registered in the Chinese Clinical Trial Registry (ChiCTR2400089115). The findings will be disseminated through academic presentations and peer-reviewed journal publications, providing valuable data and insights into the role of IoC2 in guiding intraoperative pain management.

Trial registration number
ChiCTR2400089115.

Introduction
Long-acting injectable (LAI) cabotegravir is a promising new method for preventing HIV. Safe and effective long-acting agents for pre-exposure prophylaxis (PrEP) for HIV infection are needed to increase preventive options among sexual and gender minority adolescents.

Methods and analysis
This is a multisite, prospective implementation study of three PrEP modalities (LAI-PrEP, event-driven (ED) and daily oral), using a mixed-method design with quantitative and qualitative approaches. The study will include a sample of 550 HIV-negative adolescent men who have sex with men, non-binary individuals assigned male at birth, transgender men and women, aged 15–19 years, in three Brazilian capital cities. Participants will be allocated into two arms, according to their choice of PrEP modalities, and followed up to 36 months. Switching between oral and LAI-PrEP will be allowed, according to the participants’ needs and preferences. The qualitative studies will focus on investigating the processes involved in linkage and retention in care, switching between PrEP modalities and strategies of the implementation process of LAI-PrEP in the current PrEP programming and acceptability from health providers, policymakers and stakeholders’ perspectives.

Ethics and dissemination
The adolescent’s autonomy for consenting to their participation and understanding of PrEP will be assessed by the project team before any care is given and will be recorded in their medical record. Adolescents aged 15–17 years will sign an informed assent form, waiving the need for the approval of a legal guardian, except in cases where the adolescent is found not to have the necessary autonomy. The study was approved by the WHO Ethics Review Committee and by the local IRBs from the universities coordinating the study, the University of São Paulo, the Federal University of Bahia and the Federal University of Minas Gerais. This project is part of an effort to expedite the inclusion of new modalities in the Brazilian PrEP Programme, based on the development of studies to evaluate the implementation of LAI-PrEP and ED-PrEP as a choice. The results will be published in peer-reviewed journals and presented to the study participants and communities.

Trial registration number
https://ensaiosclinicos.gov.br/rg/RBR-104736f4. The trial registration number: RBR-104736f4

Introduction
Individuals with higher neurological levels of spinal cord injury (SCI) at or above the sixth thoracic segment (≥T6), exhibit impaired resting cardiovascular control and responses during upper-body exercise. Over time, impaired cardiovascular control predisposes individuals to lower cardiorespiratory fitness and thus a greater risk for cardiovascular disease and mortality. Non-invasive transcutaneous spinal cord stimulation (TSCS) has been shown to modulate cardiovascular responses at rest in individuals with SCI, yet its effectiveness to enhance exercise performance acutely, or promote superior physiological adaptations to exercise following an intervention, in an adequately powered cohort is unknown. Therefore, this study aims to explore the efficacy of acute TSCS for restoring autonomic function at rest and during arm-crank exercise to exhaustion (AIM 1) and investigate its longer-term impact on cardiorespiratory fitness and its concomitant benefits on cardiometabolic health and health-related quality of life (HRQoL) outcomes following an 8-week exercise intervention (AIM 2).

Methods and analysis
Sixteen individuals aged ≥16 years with a chronic, motor-complete SCI between the fifth cervical and sixth thoracic segments will undergo a baseline TSCS mapping session followed by an autonomic nervous system (ANS) stress test battery, with and without cardiovascular-optimised TSCS (CV-TSCS). Participants will then perform acute, single-session arm-crank exercise (ACE) trials to exhaustion with CV-TSCS or sham TSCS (SHAM-TSCS) in a randomised order. Twelve healthy, age- and sex-matched non-injured control participants will be recruited and will undergo the same ANS tests and exercise trials but without TSCS. Thereafter, the SCI cohort will be randomly assigned to an experimental (CV-TSCS+ACE) or control (SHAM-TSCS+ACE) group. All participants will perform 48 min of ACE twice per week (at workloads corresponding to 73–79% peak oxygen uptake), over a period of 8 weeks, either with (CV-TSCS) or without (SHAM-TSCS) cardiovascular-optimised stimulation. The primary outcomes are time to exhaustion (AIM 1) and cardiorespiratory fitness (AIM 2). Secondary outcomes for AIM 1 include arterial blood pressure, respiratory function, cerebral blood velocity, skeletal muscle tissue oxygenation, along with concentrations of catecholamines, brain-derived neurotrophic factor and immune cell dynamics via venous blood sampling pre, post and 90 min post-exercise. Secondary outcomes for AIM 2 include cardiometabolic health biomarkers, cardiac function, arterial stiffness, 24-hour blood pressure lability, energy expenditure, respiratory function, neural drive to respiratory muscles, seated balance and HRQoL (eg, bowel, bladder and sexual function). Outcome measures will be assessed at baseline, pre-intervention, post-intervention and after a 6-week follow-up period (HRQoL questionnaires only).

Ethics and dissemination
Ethical approval has been obtained from the Wales Research Ethics Committee 7 (23/WA/0284; 03/11/2024). The recruitment process began in February 2024, with the first enrolment in July 2024. Recruitment is expected to be completed by January 2026. The results will be presented at international SCI and sport-medicine conferences and will be submitted for publication in peer-reviewed journals.

Trial registration number
ISRCTN17856698.

Objectives
This study evaluates the prevalence and correlates of opioid agonist therapy (OAT) discontinuation across British Columbia (BC), using a sample of individuals who used substances and accessed harm reduction sites.

Design
This study uses data from the 2019 cross-sectional Harm Reduction Client Survey (HRCS).

Setting
The 2019 survey was administered from October to December at 22 harm reduction supply distribution sites across the 5 Regional Health Authorities of BC.

Participants
The 2019 HRCS was administered among individuals who used illicit substances in the past 6 months and were aged 19 years and above.

Primary and secondary outcome measures
The primary outcome was defined as self-reported discontinuation of OAT in the past 6 months. Measures of association (2 and Fisher’s exact tests) and logistic regression models were used to assess the strength of association between OAT discontinuation and demographic, socioeconomic, accessibility, drug use and harm reduction correlates.

Results
Of the 194 participants included, 59.8% self-identified as cis man, 37.6% self-identified as Indigenous, 38.1% were aged 30–39 years and 43.8% had discontinued OAT in the past 6 months. Multivariable logistic regression analyses identified that those aged ≥50 years (AOR=0.12, 95% CI (0.03 to 0.45)) and those who took the survey in medium/large urban areas (AOR=0.27, 95% CI (0.07 to 0.98)) were significantly less likely to discontinue OAT, while those who experienced an overdose in the past 6 months were significantly more likely (AOR=3.77, 95% CI (1.57 to 9.03)) to have discontinued OAT in the past 6 months. Substance use, including opioids and stimulants, was similar among those who continued and discontinued OAT. Of the 73 participants who discontinued OAT and provided a reason, one-third reported discontinuing OAT because treatment was not effective, 27.4% could not get to the pharmacy during open hours, 23.3% could not make their clinic appointment and 15.1% reported challenges with transportation/travel.

Conclusions
OAT discontinuation prevention efforts for individuals using substances in BC need to address disparities in healthcare accessibility, especially in rural areas and among younger individuals. Continued access to harm reduction services can allow for safer consumption of substances for individuals enrolled in OAT programs.

Objectives
Long-acting reversible contraception (LARC) provides continuous pregnancy prevention to women for a period of 3 to 12 years, and it is very safe and effective. The aim of this study was to determine the prevalence, determinants and willingness to use LARC among undergraduate female students attending public and private universities in Ekiti State, Southwest Nigeria

Design
This survey employed a cross-sectional comparative study design.

Setting
Public and private universities in Ekiti State, Southwest Nigeria.

Participants
418 female students in their undergraduate years at public and private universities (208 students in public universities and 210 students in private universities).

Primary and secondary outcomes
A semistructured questionnaire was used to gather data, and analysis was done using IBM SPSS V.25. Prevalence, willingness and determinants of LARC were determined and compared between public and private universities at the level of bivariate analysis using 2. Multivariate regression analysis was used to determine the predictor of LARC use. The statistical significance level was placed at a p value of

Introduction
Opioid-induced constipation (OIC) affects up to 90% of patients with cancer receiving long-term opioid-related analgesic therapy, resulting in various potential complications, compromised pain management and decreased quality of life. Laxatives stimulate or facilitate bowel evacuation. Traditional laxatives, such as polyethylene glycol and lactulose, are widely used because of their low cost, easy accessibility and tolerability. OIC prophylaxis with laxatives is recommended for patients receiving opioid therapy. However, systematic reviews that support this practice are lacking. They have primarily focused on patients with existing constipation and the effectiveness of other pharmacological therapies. Thus, we are conducting a systematic review to evaluate the efficacy and safety of traditional laxatives in preventing OIC in adult patients with cancer.

Methods and analysis
The Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols 2015 statement was used to guide the reporting of this protocol. Database searches will be performed in PubMed, Embase, Web of Science, Cochrane Library and EBSCO from inception to a date within 6 months of the submission of the full systematic review (estimated 31 December 2024). Reference lists will also be accessed for additional studies, including Google Scholar, for the inclusion of grey literature. A combination of Medical Subject Headings/Emtree and free-text terms will be used when searching the core concepts of ‘OIC’, ‘laxative’ and ‘cancer.’ The eligibility criteria will be defined by the type of population (patients with cancer receiving opioid therapy), type of intervention (traditional laxatives) and type of study (randomised controlled trials and quasi-experimental trials). Two reviewers will independently select eligible studies, extract data and assess the methodological risk of bias. A third reviewer will be invited to reach a consensus if necessary. Subgroup and sensitivity analyses will be conducted to explore sources of heterogeneity.

Ethics and dissemination
Ethical approval is not required, as patients will not be included in systematic reviews and meta-analyses. We will publish this study in a peer-reviewed journal and communicate the results at open conferences.
PROSPERO registration number
CRD42024507127.

Introduction
Chronic pain is one of the most common and serious symptoms of cancer. Despite the limitations of dose titration using only one type of opioid, the effects of opioid combinations are poorly understood.

Methods and analysis
This study will be conducted in accordance with the Cochrane Handbook of Systematic Reviews of Interventions 6.3. We will search the Cochrane Central Register of Controlled Trials (CENTRAL), Medical Literature Analysis and Retrieval System Online (MEDLINE), Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Web of Science databases from their inception to June 2023. This review will consider all clinical trials involving patients aged ≥18 years who received opioids for chronic cancer pain. Two reviewers will independently screen and select relevant studies. The intervention will be a combination of opioids, including both strong and weak, to control cancer pain. The comparator will be set as a single opioid, with or without a placebo. For randomised controlled trials, version 2 of the Cochrane tool will be used to assess the risk of bias. For non-randomised studies, the risk of bias will be assessed using a tool for assessing the Risk of Bias In Non-randomised Studies of Interventions (ROBINS-I). The primary outcome will be pain response; if a quantitative synthesis is not appropriate, a synthesis without a meta-analysis will be undertaken. The quality of evidence for each primary outcome will be assessed using the Grading of Recommendations, Assessment, Development and Evaluation guidelines.

Ethics and dissemination
Ethical approval was not required for this systematic review and meta-analysis. The findings will be disseminated through peer-reviewed (open-access) journal publications and conference presentations. Given the widespread use of opioid-based cancer pain management in clinical practice, this study is expected to generate significant interest among physicians, many of whom are likely to review and consider the findings in the context of their clinical decision-making.

PROSPERO registration number
PROSPERO CRD42023427299.

Glepaglutide is a long-acting GLP-2 analog developed to improve intestinal absorption in short bowel syndrome (SBS) patients. We conducted a trial to establish efficacy and safety of glepaglutide in reducing parenteral support (PS) needs in SBS patients with intestinal failure (IF).

Objective
To analyse the effects of tracheostomy timing on COVID-19 outcomes by comparing mortality rates at different time points (7, 10 and 14 days).

Design
Systematic review and meta-analysis.

Data sources
PubMed, Embase, Cochrane Library, Web of Science and Scopus were searched from 31 August 2023 to 6 September 2023.

Primary and secondary outcomes measures
The primary outcome was short-term mortality, defined as intensive care unit (ICU) mortality, hospital mortality and 28-day or 30-day mortality. The secondary outcomes included mechanical ventilation duration, ICU and hospital days.

Results
Among 3465 patients from 12 studies, the 10-day subgroup analysis revealed higher mortality for earlier tracheostomy than for later tracheostomy (49.7% vs 32.6%, OR 1.91, 95% CI 1.37–2.65). No significant differences were observed at 7- and 14-day marks. Earlier tracheostomy was associated with shorter mechanical ventilation (mean difference=–7.35 days, 95% CI –11.63 to –0.38) and ICU stays (mean difference=–11.24 days, 95% CI –18.50 to –3.97) compared with later tracheostomy. Regarding hospital stay, the later tracheostomy group exhibited a trend towards longer-term inpatients, with no significant difference.

Conclusions
No significant difference in short-term mortality was observed between patients undergoing tracheostomy at 7 and 14 days; however, at 10 days, later tracheostomy resulted in a lower mortality rate. Accordingly, subtle timing differences may impact short-term results in COVID-19 patients. Considering that the later tracheostomy group had longer mechanical ventilation and ICU stays, additional research is required to determine an optimal timing that reduces mortality cost-effectively.

New England Journal of Medicine, Ahead of Print.

Objectives
To evaluate the cost-effectiveness of long-acting progestogens (LAP), including levonorgestrel-releasing intrauterine system (LNG-IUS) and depot-medroxyprogesterone acetate (DMPA), compared with the combined oral contraceptives pill (COCP) in preventing recurrence of endometriosis-related pain postsurgery.

Design
Within-trial economic evaluation alongside a multicentre, pragmatic, parallel-group, open-label, randomised controlled trial (Preventing Recurrence of Endometriosis by means of Long-Acting Progestogen Therapy trial).

Setting
Thirty-four UK hospitals recruiting participants from November 2015 to March 2019.

Patients
Four hundred and five women aged 16–45 years undergoing conservative endometriosis surgery.

Interventions
The ratio of 1:1 randomisation to receive LAPs (LNG-IUS or DMPA) or COCP.

Main outcome measures
The primary evaluation was a cost-utility analysis based on cost per quality-adjusted life-year (QALY) gained at 3 years. We adopted a UK National Health Service perspective. Secondary analyses in the form of cost-effectiveness analysis based on a range of outcomes were also undertaken.

Results
For the primary analysis, the COCP group incurred an additional cost of £533 (95% CI £52 to £983) per woman compared with LAPs. Treatment with COCP generated additional QALYs of 0.031 (95% CI –0.079 to 0.139) compared with the LAP group over 36-month follow-up. The incremental cost-effectiveness ratio for COCP compared with LAPs is therefore approximately £17 193 per QALY. The probabilistic sensitivity analysis suggested that there was a 54.7% probability that COCP would be cost-effective at the £20 000/QALY threshold. The secondary analyses revealed results more in favour of LAPs.

Conclusion
Although the COCP has a slightly higher probability of being cost-effective at £20 000/QALY threshold, there remains considerable uncertainty, with only marginal differences in outcomes between the two treatments. The lower rates of further surgery and second-line medical treatment for women allocated to LAPs may make this option preferable for some women.

Trial registration number
ISRCTN 97865475.

Research has found that in nearly 40% of opioid overdose deaths, documented bystanders could have potentially administered the lifesaving medicine naloxone. But in a promising update, a new study published in JAMA Network Open found that bystander-administered naloxone has “drastically increased” in recent years.

Introduction
Opioid therapy is often central to pain management during cancer care. However, opioid exposure and unaddressed psychological suffering jointly amplify opioid use disorder risk. Therefore, we iteratively developed a behavioural, individually delivered intervention to mitigate the risk of opioid use disorder during cancer care (Acceptance and Commitment Therapy Intervention when Opioids are Necessary (ACTION)).

Methods and analysis
This is a single-site, non-blinded, randomised, controlled pilot trial of ACTION compared with a waitlist control group. The aims of this study are to examine the feasibility (defined as an overall enrolment rate of ≥60% and a retention rate of >75%) and acceptability (assessed via patient-reported feedback in exit interviews and Client Satisfaction Questionnaire-8 ratings) of ACTION (primary outcomes) and to assess changes in participant-reported depression, anxiety and opioid misuse (secondary outcomes). Patients will be recruited from Dana-Farber Cancer Institute (Boston, Massachusetts, USA). The total number of patients completing the study will be 40. All patients will complete baseline and follow-up measures after 6 weeks. Patients randomly assigned to ACTION (n=20) will receive six weekly 30-min sessions delivered by a mental health provider either via telehealth or in-person. Patients assigned to the waitlist control group (n=20) will be offered the intervention on completion of their follow-up assessments, approximately 6 weeks (±2 weeks), following baseline.

Ethics and dissemination
This study is approved by the Dana-Farber/Harvard Cancer Center Institutional Review Board (Protocol #21-587). Participants provide either written or electronic informed consent on study approach and once enrolled, they can withdraw from the study at any time. Results will be published in peer-reviewed journals and presented at scientific meetings.

Trial registration number
NCT05643027.

Stroke, Ahead of Print. BACKGROUND:The tissue-based definition of transient ischemic attack, which requires the use of diffusion-weighted imaging (DWI), has limitations in its applicability to clinical practice. This contributes to the limited evidence regarding the risk of subsequent stroke and the associated predictors in the group of patients who are tissue-negative on DWI. Our aim was to assess the early and long-term prognoses of consecutive patients with tissue-negative transient ischemic attacks attended at an emergency department.METHODS:We performed a prospective cohort study of consecutive patients with neurologist-confirmed transient ischemic attack who were DWI-negative from January 2006 to June 2010. All patients underwent DWI on magnetic resonance imaging (4.0 [SD, 1.8] days) after the index event. The risk and predictors of stroke recurrence (SR) were determined at 1 year and after a median follow-up time of 6.6 (interquartile range, 5.0–9.6) years.RESULTS:A total of 370 patients were included. Previously, 244 patients with positive DWI results and 109 patients without magnetic resonance imaging performed were excluded. ABCD2 score >5 was determined in 95 (26.2%) patients; 15 (4.1%) patients experienced SR at 1 year and 18 (4.9%) beyond 1 year. Predictive models for short- and long-term prognoses were different. Large artery atherosclerosis cause (hazard ratio, 3.7 [95% CI, 1.2–11.0]) was the only predictor of 1-year SR. In contrast, male sex (hazard ratio, 4.17 [95% CI, 1.14–15.23];P=0.031), speech impairment (hazard ratio, 4.90 [95% CI, 1.05–22.93];P=0.044), and the presence of chronic microangiopathy expressed as Fazekas score of 3 (hazard ratio, 1.84 [95% CI, 1.15–2.97];P=0.012) were predictors of long-term SR follow-up.CONCLUSIONS:Patients with DWI-negative have a clinically important risk of recurrent vascular events and SR during medium- and long-term follow-ups. These patients warrant optimized secondary prevention to reduce their risk of recurrent vascular events over time. Predictors of SR varied over the follow-up.

Objectives
Opioid agonist, partial agonist and antagonist medications are used to treat opioid use disorder (OUD). This was the first omnibus narrative systematic review of the contemporary qualitative literature on patient experiences of receiving these medications.

Design
Narrative systematic review using the sample, phenomenon of interest, design, evaluation and research framework.

Data sources
PubMed, Embase and APA PsycINFO were searched between 1 January 2000 and 14 June 2023, with the addition of hand searches.

Eligibility criteria for selecting studies
Qualitative and mixed methods studies among adults with experience of receiving OUD treatment medication in community and criminal justice settings.

Data extraction and synthesis
One reviewer conducted searches using the pre-registered strategy. Two independent reviewers screened studies and assessed quality using the Consolidation Criteria for Reporting Qualitative tool. Identified reports were first categorised using domains from the addiction dimensions for assessment and personalised treatment (an instrument developed to guide OUD treatment planning), then by narrative synthesis.

Results
From 1129 studies, 47 reports (published between 2005 and 2023) were included. Five major themes (and nine subthemes) were identified: (1) expectations about initiating treatment (barriers to access; motivations to receive medication); (2) responses to medication induction and stabilisation; (3) experience of the dispensing pharmacy (attending; medication dispensing); (4) experiences of maintenance treatment (services; dose adjustment; personal and social functioning); and (5) social factors (integration and stigma) and experiences of discontinuing treatment. Together these themes reflected and endorsed the importance of patient-centred care and clinically integrated services. Further qualitative research in real-world settings is needed on extended-release buprenorphine given the relative novelty of this medication option.

Conclusions
A narrative systematic review of the qualitative studies of medications for OUD endorsed the importance of patient-centred care and clinically integrated services.

PROSPERO registration number
CRD42019139365.

This population-based retrospective cohort study uses linked health administrative databases to assess the risk of treatment discontinuation and mortality among adults in British Columbia, Canada, receiving buprenorphine/naloxone vs methadone for the treatment of opioid use disorder.