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Abstract Rationale Diesel exhaust (DE), an established model of traffic-related air pollution, contributes significantly to the global burden of asthma and may augment the effects of allergen inhalation. Newer diesel particulate-filtering technologies may increase NO2 emissions, raising questions regarding their effectiveness in reducing harm from associated engine output. Objectives To assess the effects of DE and allergen coexposure on lung function, airway responsiveness, and circulating leukocytes, and determine whether DE particle depletion remediates these effects. Methods In this randomized, double-blind crossover study, 14 allergen-sensitized participants (9 with airway hyperresponsiveness) underwent inhaled allergen challenge after 2-hour exposures to DE, particle-depleted DE (PDDE), or filtered air. The control condition was inhaled saline after filtered air. Blood sampling and spirometry were performed before and up to 48 hours after exposures. Airway responsiveness was evaluated at 24 hours. Measurements and Main Results PDDE plus allergen coexposure impaired lung function more than DE plus allergen, particularly in those genetically at risk. DE plus allergen and PDDE plus allergen each increased airway responsiveness in normally responsive participants. DE plus allergen increased blood neutrophils and was associated with persistent eosinophilia at 48 hours. DE and PDDE each increased total peripheral leukocyte counts in a manner affected by participant genotypes. Changes in peripheral leukocytes correlated with lung function decline. Conclusions Coexposure to DE and allergen impaired lung function, which was worse after particle depletion (which increased NO2). Thus, particulates are not necessarily the sole or main culprit responsible for all harmful effects of DE. Policies and technologies aimed at protecting public health should be scrutinized in that regard. Clinical trial registered with www.clinicaltrials.gov (NCT02017431).

Nitrous oxide is commonly used in general anaesthesia but concerns exist that it might increase perioperative cardiovascular risk. We aimed to gather evidence to establish whether nitrous oxide affects perioperative cardiovascular risk. We did an international, randomised, assessor-blinded trial in patients aged at least 45 years with known or suspected coronary artery disease having major non-cardiac surgery. Patients were randomly assigned via automated telephone service, stratified by site, to receive a general anaesthetic with or without nitrous oxide. Attending anaesthetists were aware of patients' group assignments, but patients and assessors were not. The primary outcome measure was a composite of death and cardiovascular complications (non-fatal myocardial infarction, stroke, pulmonary embolism, or cardiac arrest) within 30 days of surgery. Our modified intention-to-treat population included all patients randomly assigned to groups and undergoing induction of general anaesthesia for surgery. This trial is registered at ClinicalTrials.gov, number NCT00430989. Of 10 102 eligible patients, we enrolled 7112 patients between May 30, 2008, and Sept 28, 2013. 3543 were assigned to receive nitrous oxide and 3569 were assigned not to receive nitrous oxide. 3483 patients receiving nitrous oxide and 3509 not receiving nitrous oxide were assessed for the primary outcome. The primary outcome occurred in 283 (8%) patients receiving nitrous oxide and in 296 (8%) patients not receiving nitrous oxide (relative risk 0·96, 95% CI 0·83–1·12; p=0·64). Surgical site infection occurred in 321 (9%) patients assigned to nitrous oxide, and in 311 (9%) patients in the no-nitrous oxide group (p=0·61), and severe nausea and vomiting occurred in 506 patients (15%) assigned to nitrous oxide and 378 patients (11%) not assigned to nitrous oxide (p<0·0001). Our findings support the safety profile of nitrous oxide use in major non-cardiac surgery. Nitrous oxide did not increase the risk of death and cardiovascular complications or surgical-site infection, the emetogenic effect of nitrous oxide can be controlled with antiemetic prophylaxis, and a desired effect of reduced volatile agent use was shown. Australian National Health and Medical Research Council; Australian and New Zealand College of Anaesthetists; Heart and Stroke Foundation of Quebec, Heart and Stroke Foundation of Ontario, Canada; General Research Fund of the Research Grant Council, Hong Kong Special Administrative Region, China.

IntroductionComplex Regional Pain Syndrome (CRPS) is a debilitating neuropathic condition often refractory to conventional treatments. N-methyl-D-aspartate (NMDA) receptor antagonists have a well-established role in the development and modulation of chronic neuropathic pain. Nitrous oxide is widely used and generally safe anesthetic gas with NMDA receptor antagonist activity. We therefore tested the hypothesis that brief periods of nitrous oxide exposure reduce pain in patients with CRPS.MethodsPatients with a diagnosis of CRPS were randomized to either 2 hours of nitrous oxide exposure on three alternating days (Nitrous Oxide) versus a placebo air/oxygen mixture (Air-Oxygen). Our primary outcome was patient-reported pain scores at 1 week and 1 month. Secondary and exploratory outcomes were physical and mental health (PRMOIS-29 v2 survey), specific neuropathic pain symptoms (McGill short-form questionnaire), and opioid consumption.Results44 patients participated in the study; 20 were randomized to Nitrous Oxide and 24 were assigned to Air-Oxygen. Pain scores did not differ significantly, with the estimated difference in means (Nitrous Oxide−Air-Oxygen) of −0.57 (95% CI: −1.42 to 0.28) points, p=0.19. There were also no differences detected in secondary outcomes, with the estimated difference in mean Z-scores for physical health (Nitrous Oxide−Air-Oxygen) of 0.13 (95% CI: −0.16 to 0.43), mental health 0.087 (95% CI: −0.31 to 0.48), and Patient Global Impression of Change score −0.7 (95% CI: −1.85 to 0.46).ConclusionsCompared with air/oxygen, 2 hours of nitrous oxide/oxygen exposure for three sessions did not provide meaningful therapeutic potential for patients with chronic CRPS. Our results do not support using nitrous oxide for the treatment of CRPS.

Background Children often experience anxiety and pain during minor surgical procedures, prompting the search for effective pain management strategies beyond traditional pharmaceutical approaches. This study aims to evaluate the efficacy of virtual reality (VR) as a pain reduction method in pediatric outpatient surgical interventions compared to the standard use of nitrous oxide. The research questions explore pain reduction levels, patient preferences, enjoyment during VR use, and the time limit of the VR application. Methods The study employs a randomized controlled trial design, utilizing VR technology and nitrous oxide in separate groups in 100 children at the age from 6 to 15 undergoing minor surgical procedures. Outcomes are monitored directly after the intervention and two weeks following the procedure. The primary outcome measure is the pain level, assessed using visual face and visual analog scales. Secondary outcomes are the fun and/or fear experienced during the intervention, the willingness to undergo the same procedure again (if necessary), and whether there is a time limit with the VR application compared to nitrous oxide. The study also considers adverse events and safety measures. Discussion The study aims to address a significant research gap in pediatric pain management strategies, as it is the first randomized controlled trial designed to compare pain levels using VR versus a control group with nitrous oxide analgosedation in children undergoing minor surgical procedures. Preliminary evidence suggests VR may offer a viable alternative to traditional pain management methods, as VR technology could be an effective distraction and pain management tool for pediatric patients undergoing outpatient surgical procedures. Trial registration ClinicalTrials.gov NCT05510141. Registered on August 22, 2022. Virtual Reality Games in Pediatric Surgery—Full Text View—ClinicalTrials.gov. Trial sponsor The principal investigator, Cordula Scherer act as the Sponsor, Clinic for pediatric surgery, Inselspital, Bern University Hospital, CH 3010 Bern, Switzerland.

Background The prevalence of ankle fractures is increasing globally. Postoperative rehabilitation exercises constitutes an essential component of the surgical procedure. However, the severe pain in postoperative rehabilitation exercises remains a clinical problem. The objective of this study is to ascertain whether the administration of premixed nitrous oxide provides effective pain relief during the postoperative rehabilitation phase following the treatment of ankle fractures. Methods This study employed a single-center, randomized, double-blind controlled trial design. This study will enroll 100 patients. Patients undergoing rehabilitation exercises with acute pain (VAS ≥ 4) at least 1 month after ankle open reduction and internal fixation will be eligible for inclusion. Patients will be assigned in a 1:1 ratio through a randomization process to an intervention group receiving a pre-prepared nitrous oxide/oxygen mixture or a control group receiving oxygen. Rehabilitation therapy will perform by a professional rehabilitation therapist. The primary outcome is pain score, and the secondary outcomes include anxiety score, physiological indicators, side events, satisfaction from patients and medical staffs, acceptance, and residual pain after rehabilitation. Discussion The study is an in-depth examination of the analgesic effect of nitrous oxide applied to postoperative rehabilitation exercises of ankle fracture. If this method proves to be successful, it could be widely applied to patients in postoperative rehabilitation exercises for ankle fracture, providing a new idea for pain management in the field of postoperative rehabilitation. Trial registration Chinese Clinical Trial Register ChiCTR2400089379. Registered on September 9, 2024. https://www.chictr.org.cn/showproj.html?proj=236994

Background Laceration repairs are a common, yet distressing procedure in children. While a range of strategies is used to treat this distress, there is currently no standard of care. The Anxiolysis for Laceration Repair in Children (ALICE) trial aims to identify the most effective pharmacological agent to manage laceration repair-associated distress. This paper outlines the statistical analysis plan for the ALICE trial.  The ALICE trial is a phase III, Bayesian, open-label trial that will identify the optimal agent for reducing distress among intranasal dexmedetomidine (IND), intranasal midazolam (INM), and inhaled nitrous oxide (N 2 O). The primary outcome, distress, will be measured by the Observational Scale of Behavioural Distress – Revised (OSBD-R). Scores from the OSBD-R will be analyzed using a Bayesian mixed effects model with data-driven prior distributions. Samples from the model’s posterior distributions will be used to calculate the probability of being best statistic (P best ), which will effectively rank the interventions. The trial will also evaluate delayed maladaptive behaviours, need for additional physical restraint, adverse events, and need for additional sedation as secondary outcomes. Furthermore, the trial will determine the costs associated with achieving adequate sedation in each treatment arm. Discussion This statistical analysis plan specifies the outcomes and analyses for the ALICE trial. The ALICE trial will provide evidence for the most effective agent for reducing distress in children receiving laceration repairs. Trial registration ClinicalTrials.gov NCT05383495 . Registered on May 16, 2022. 

Transrectal ultrasound-guided biopsy (TUSPB) is the standard method of diagnosis for prostate cancer, and although it is well tolerated by some patients, it presents a discomfort rate of 65 to 90%, which may be associated with pain. For convenience, it is agreed that a method of analgesia and sedation is necessary. For this purpose, this study aimed to evaluate the impact of inhalation of a 50-50% N2O-O2 gas mixture on pain intensity in these patients. Randomized, double-blinded clinical trial, conducted at Antônio Pedro University Hospital (Hospital Universitário Antônio Pedro), Niterói, RJ, Brazil, containing two groups of 42 patients: a control (C) group, which received 100% oxygen inhalation, and a nitrous oxide (NO) group, which received inhalation of the 50-50% N2O-O2 mixture, self-administered during TUSPB. The pain intensity and degree of satisfaction were evaluated through a visual analogue scale (VAS), as was the frequency of adverse events. Eighty-four patients were included in the study, with 42 in each group. The mean pain intensity was lower in the NO group than in the C group [2.52 (0-10) vs 5.95 (0-10), p < 0.001], and the degree of satisfaction was higher in the NO group than in the C group (8.14 vs. 4.69, p < 0.001). The adverse effects were somnolence, dizziness, nausea, vomiting, discomfort and euphoria without differences between the groups. The 50-50% N2O-O2 mixture was effective in reducing pain intensity and increasing the degree of satisfaction in TUSPB, with tolerable side effects.

Background Patients with hematological malignancies received multiple hypodermic injections of recombinant human granulocyte colony-stimulating factor. Procedural pain is one of the most common iatrogenic causes of pain in patients with hematological malignancies. It is also identified as the most commonly occurring problem in clinical care in the Department of Hematology and Oncology at Shenzhen University General Hospital. However, providing immediate relief from pain induced by hypodermic injection of recombinant human granulocyte colony-stimulating factor remains a major challenge. This trial aims to evaluate the safety and analgesic efficacy of a fixed nitrous oxide/oxygen mixture for patients with hematological malignancies and experiencing procedural pain caused by hypodermic injection of recombinant human granulocyte colony-stimulating factor in the department. Methods The nitrous oxide/oxygen study is a single-center, randomized, double-blind, placebo-controlled trial involving patients with hematological malignancies who require hypodermic injections of recombinant human granulocyte colony-stimulating factor for treatment. This trial was conducted in the Hematology and Oncology Department of Shenzhen University General Hospital. A total of 54 eligible patients were randomly allocated to either the fixed nitrous oxide/oxygen mixture group ( n = 36) or the oxygen group ( n = 18). Neither the investigators nor the patients known about the randomization list and the nature of the gas mixture in each cylinder. Outcomes were monitored at the baseline (T0), immediately after hypodermic injection of recombinant human granulocyte colony-stimulating factor (T1), and 5 min after hypodermic injection of recombinant human granulocyte colony-stimulating factor (T2) for each group. The primary outcome measure was the score in the numerical rating scale corresponding to the highest level of pain experienced during hypodermic injection of recombinant human granulocyte colony-stimulating factor. Secondary outcomes included the fear of pain, anxiety score, four physiological parameters, adverse effects, total time of gas administration, satisfaction from both patients and nurses, and the acceptance of the patients. Discussion This study focused on the safety and analgesic efficacy during hypodermic injection of recombinant human granulocyte colony-stimulating factor procedure. Data on the feasibility and safety of nitrous oxide/oxygen therapy was provided if proven beneficial to patients with hematological malignancies during hypodermic injection of recombinant human granulocyte colony-stimulating factor and widely administered to patients with procedural pain in the department. Trial registration Chinese Clinical Trial Register, ChiCTR2200061507. Registered on June 27, 2022. http://www.chictr.org.cn/edit.aspx?pid=170573&htm=4

BackgroundNitrous oxide (N2O) has been reported to increase the risk of postoperative nausea and vomiting (PONV) in a dose-dependent manner. We investigated the effect of adding N2O at the end of isoflurane inhalational anesthesia on the recovery and incidence of PONV. Our hypothesis was that N2O would reduce the time to early recovery without increasing the incidence of PONV.MethodsAfter obtaining ethics committee approval and written informed consent, 100 women at American Society of Anesthesiologists physical status I-III and scheduled for laparoscopic-assisted vaginal hysterectomy were randomized into two groups (G) according to the carrier gas: GO2 (air in 30% oxygen) and GN2O (the same mixture until the last 30 min of surgery, when 70% N2O in 30% oxygen was used). No PONV prophylaxis was given. Anesthesia was induced with thiopental 5 mg·kg−1, vecuronium 0.1 mg·kg−1, and fentanyl 1-2 μg·kg−1iv and maintained with isoflurane. Indicators of early recovery (time to extubation, eye opening, following commands, orientation) were assessed by an anesthesiologist unaware of the group assignment. The incidence and severity of PONV was measured at two and 24 hr postoperatively.ResultsAltogether, 82 participants completed the study (42 in GO2, 40 in GN2O) and were analyzed. The mean (SD) time of N2O administration in GN2O patients was 27.1 (10.1) min. The mean (SD) time to extubation was faster in GN2O patients [5.4 (2.9) min] than in GO2 patients [7.5 (3.7) min] (mean difference, 2.0 min; 95% confidence interval [CI], 0.6 to 3.4, P = 0.009). The ability to open eyes, follow commands, and being oriented were all faster in GN2O patients than in GO2 patients (differences of 3.9 min, 95% CI, 1.6 to 6.1, P = 0.001; 3.4 min, 95% CI, 1.0 to 5.7, P = 0.006; 3.8 min, 95% CI, 0.9 to 6.7, P = 0.010, respectively). The incidence of PONV was not different between the groups, but the rescue antiemetic was required less often in the GN2O patients (mean difference in metoclopramide dose between the GN2O and GO2 groups, 5.1 mg; 95% CI, 0.8 to 9.4, P = 0.019).ConclusionsAdding N2O during the last 30 min of an isoflurane-based inhalational anesthetic reduced the time to extubation, eye opening, and orientation.

Background The morbidity of knee arthritis is increasing among aged people and total knee arthroplasty has been its mainstream treatment to date. Postoperative rehabilitation is an important part of the procedure. However, the intense pain during the functional exercise involved has always been a challenge for both patients and health care professionals. The aim of this study is to test the analgesic effect of a mixture of nitrous oxide/oxygeb (1:1) inhalation for patients who are doing functional exercise 1 month after total knee arthroplasty. Methods/design This double-blind, randomized, placebo-controlled study will be implemented in the Rehabilitation Department in the General Hospital of Ningxia Medical University. Patients aged between 50 and 75 years who underwent a primary unilateral total knee arthroplasty are eligible for inclusion. The key exclusion criteria include: epilepsy, pulmonary embolism, intestinal obstruction, aerothorax. The treatment group (A) will receive a pre-prepared nitrous oxide/oxygen mixture plus conventional treatment (no analgesics), and the control group (B) will receive oxygen plus conventional treatment (no analgesics). Patients, physicians, therapists, and data collectors are all blind to the experiment. Assessments will be taken immediately after functional exercise begins (T0), 5 min (T1) after functional exercise begins, and 5 min after functional exercise has finished (T2). Patients will be randomly allocated between a treatment group (A) and a control group (B) in a ratio of 1:1. Primary outcome, including pain severity in the procedure, will be taken for each group. Secondary outcomes include blood pressure, heart rate, oxygen saturation, side effects, knee joint range of motion, Knee Society Score (KSS), rescue analgesia need, and satisfaction from both therapists and patients. Discussion This study will focus on exploring a fast and efficient analgesic for patients who are doing functional exercise after total knee arthroplasty. Our previous studies suggested that the prefixed nitrous oxide/oxygen mixture was an efficacious analgesic for the management of burn-dressing pain and breakthrough cancer pain. The results of this study should provide a more in-depth insight into the effects of this analgesic method. If this treatment proves successful, it could be implemented widely for patients doing functional exercise in the rehabilitation department. Trial registration ChiCTR-INR-17012891 . Registered on 6 October 2017.