Clinical Research Directory

Impact of Vitamin C on opioïd Consumption After an Emergency Department Visit for Acute Musculoskeletal Pain

Recent evidence has shown that vitamin C has some analgesic properties and can therefore reduce opioids used during healing. Vitamin C analgesic effect has been explored mostly during the short-term postoperative context or in disease specific chronic pain prevention but not after acute musculoskeletal injuries, which are often seen in the emergency department (ED). The study's primary aim is to compare the total morphine 5 mg equivalent pills consumed during a two-week follow-up between patients receiving vitamin C or a placebo after ED discharge for an acute musculoskeletal pain complaint. The investigators will conduct a double-blind randomized placebo-controlled trial with 464 participants distributed in two arms, one group receiving 1 000 mg of vitamin C twice a day for 14 days and another one receiving a placebo. Participants will be ≥18 years of age, treated in ED for acute musculoskeletal pain present for less than 2 weeks, and discharged with an opioid prescription for home pain management. Total morphine 5 mg equivalent pills consumed during the two-week follow-up will be assessed via an electronic (or paper) diary. In addition, patients will report their daily pain intensity, pain relief, side effects, and other types of pain medication or other non-pharmacological approach (ice, heat, immobilization, etc.) used. Three months after the injury, participants will also be contacted to evaluate chronic pain development. The investigators hypothesized that vitamin C, compared to a placebo, will reduce opioid consumption during a 14-day follow-up for ED discharged patients treated for acute pain.

Intravenous Methadone in Perioperative Acute and Chronic Management in Chinese Adult Cardiac Surgical Patients

Despite modern day improvements in pain treatment and availability of different analgesic modalities, suboptimal postoperative pain control remains an issue in cardiac surgical patients. Poorly controlled acute postoperative pain is associated with adverse physiological outcomes that impair the recovery of cardiac surgical patients. It is associated with decreased patient satisfaction, delayed postoperative ambulation, and the development of chronic postsurgical pain (CPSP). Intravenous opioids such as fentanyl and morphine have been the mainstay of perioperative analgesia for cardiac surgery, either by intermittent boluses by healthcare staff or through a patient-controlled device (PCA). The primary problem with this mechanism of delivery is that significant fluctuations in serum opioid concentrations can occur, resulting in effects which range from inadequate analgesia to overdose and respiratory depression. In contrast to intermittent administration of short-acting opioids such as morphine and fentanyl, a single dose administration of methadone can be considered.

Affecting Factors for Chronic Pain After Mastectomy

Chronic post-mastectomy pain (CPMP) is a significant issue affecting many women after mastectomy. Factors like age, treatment type, and pre-surgery pain can increase the risk of developing this condition. By evaluating these factors, CPMP can be prevented more successfully and treatment strategies can be developed. This study aims to investigate the factors contributing to CPMP and contribute to the existing literature on this important topic.

Butyrate and Taurine for Chronic Postsurgical Pain in Adult Cardiac Surgical Patients

This study is a single-center, phase II, randomized, placebo-controlled, Bayesian-designed, double-blinded trial Goal and Questions: The primary goal is to evaluate if a combination of taurine and butyrate can reduce chronic postsurgical pain (CPSP) in adult cardiac surgical patients. The study also aims to determine if these compounds are safe, effective in perioperative pain control, and feasible for improving postoperative outcomes. Participants: The study will include adult patients (aged 18 or older) undergoing elective coronary artery bypass graft (CABG), valve repair/replacement, combined CABG/valve, or major aortic procedure via sternotomy. Exclusion criteria include emergency surgery, redo surgery, a history of chronic pain or chronic opioid/sedative use, and an estimated glomerular filtration rate (eGFR) less than 30 mL/min. The target sample size is 216 patients. Intervention group: Patients will receive 4g of taurine and 4.8g of sodium butyrate orally once daily, starting the day before surgery and continuing for three months post-surgery. Placebo group: Patients will receive indistinguishable placebo capsules orally once daily, following the same schedule as the intervention group. Primary Outcome: The incidence of chronic postsurgical pain at 3 months, Secondary Outcomes: Quality of Recovery Questionnaire (QoR-15) at 72 hours after extubation. Pain scores (NRS) at rest and with movement at 12, 24, 48, and 72 hours post-extubation. Postoperative morphine requirements and time to first morphine rescue. Incidence of opioid-related side effects, such as postoperative nausea and vomiting (PONV). Duration of mechanical ventilation, and length of stay in the ICU and hospital. Long-term pain assessment using the Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2), Brief Pain Inventory (BPI) Interference Scale, and Neuropathic Pain Questionnaire (NPQ) at 1, 3, 6, and 12 months post-surgery Proteomic analysis: Blood samples within 72 hours after surgery will be collected for proteomic analysis to investigate predictors for chronic postsurgical pain.

Biofeedback Based Virtual Reality Intervention to Manage Postoperative Pain

To develop and refine a technology based treatment protocol for preoperative education and training and postoperative care in children and adolescents undergoing surgery.

EHR Precision Drug Treatment in Neonates

This observational study is designed to evaluate the integration of a model-informed, clinically individualized pharmacokinetics (PK) profile (precision dosing dashboard) into prescribing clinicians' existing workflows to improve safety and efficacy of morphine dosing for neonates. The investigators will use user-centered participatory design methods and real-time analysis to inform the refinement of the recently developed Electronic Health Record (EHR) model-based decision support tool and test it during the pre-and post-implementation stages.

Latinx Children and Surgery

Over 60 million persons in the United States (US) identify themselves as Latinx and 25.6% are children under the age of 16. Surgical disparities for adults and children have been identified as a major problem in the US and can be experienced at multiple points along a patient's health care trajectory. Data from the investigator's center indicates that a substantial portion of Latinx children who undergo surgery experience high anxiety and postoperative pain as well as postoperative impairments in psychological and physical functioning as compared to White non-Latin children who undergo surgery. Recent growth in use of mobile devices provides us an opportunity to create low-cost mobile health (mHealth) behavioral interventions to reduce this disparity in surgical outcomes. In a previous National Institutes of Health (NIH) award, the principal investigator (PI) developed and tested an evidence based mHealth tailored intervention (WebTIPS) that aims to prepare and be a companion of a child and their family during a surgical event. WebTIPS aims to enhance the recovery of the child in several ways such as reducing anxiety and pain and is based on information provision, modeling, and teaching of coping skills. WebTIPS, however, was developed and validated with a population of primarily White non-Latinx English-speaking children and their parents. Unfortunately, it is well established that mHealth interventions are significantly less effective when used with specific ethnic minorities unless they underwent a process of cultural adaptation. Over the past 4-years, the investigators have established multiple academic and community collaborations, conducted extensive participatory research with Latinx stakeholders and used the heuristic framework and a modified ecological validity model to culturally adapt WebTIPS. The culturally adapted intervention is called L-WebTIPS. The overall aim of this application is to reduce surgical disparities in a population of Latinx children undergoing surgery. The first phase of this application (R61) includes web programming of L-WebTIPS, and a feasibly randomized control trial (RCT) to test this intervention. The second phase (R33) includes a multi-center RCT which aims to determine the effectiveness of L-WebTIPS compared to attention control intervention in decreasing postoperative pain, opioids consumption and lowering anxiety in Latinx children undergoing outpatient surgery. Secondary aims of the R33 include examining the impact of L-WebTIPS on home-based clinical recovery parameters such as pain, analgesic requirements, new onset behavioral changes and return to normal daily activity in Latinx children undergoing outpatient surgery. The investigators also plan to determine if the use of L-WebTIPS reduces anxiety and improve experience among the parents of Latinx children undergoing surgery. Finally, the investigators plan to determine if the use of L-WebTIPS reduces anxiety and enhance experience among the parents of Latinx children undergoing surgery. The investigators submit that using a cultural adaption process for an existing validated intervention will accelerate the process of reducing surgical disparities and bringing an effective intervention to clinical settings and routine use.

Nebulized Ketamine to Nebulized Fentanyl for Treating Acute Painful Conditions in the ED

In situations where intravenous access is not readily available or is unobtainable and the intranasal route is not feasible, another non-invasive route of ketamine administration, such as inhalation via breath-actuated Nebulizer (BAN), is becoming a viable alternative. The BAN allows the controlled, patient-initiated delivery of analgesics in a measured and titratable fashion. (18) Ketamine has been studied as a nebulized drug in a lot of different settings and for a lot of different reasons, such as to treat acute pain after surgery (like a sore throat after being intubated), as a pre-medication for general anesthesia, to treat cancer pain, and as a therapy for asthmaticus. Our research team has published two case series of 10 adult patients who were given nebulized ketamine (via BAN) for a variety of acute traumatic and non-traumatic painful conditions. The patients showed a 60% decrease in pain and a small number of side effects. Furthermore, our group published a randomized, double-blind trial of 120 adult patients evaluating the analgesic efficacy and safety of nebulized ketamine at three different dosing regimens for acute pain in the ED (0.75 mg/kg, 1 mg/kg, and 1.5 mg/kg), showing similar analgesic efficacy between the three different dosing regimens for short-term (up to 120 minutes) pain relief. Lastly, we recently completed a randomized, double-blind, double-dummy clinical trial comparing the analgesic efficacy and safety of nebulized ketamine and intravenous ketamine in managing acute pain in adult ED patients, with data currently being analyzed. Nebulized fentanyl given in the ED to adults with acute traumatic and non-traumatic pain syndromes at a dose range of 1.5-4 mcg/kg showed the same or even better pain-relieving effects than IV fentanyl and IV morphine alone. Our objective is to compare the analgesic efficacy and rates of side effects of a 0.75 mg/kg dose of ketamine administered via breath-actuated nebulizer (BAN) to a dose of 3 mcg/kg of fentanyl administered via breath-actuated nebulizer (BAN) in adult patients presenting to the ED with acute painful conditions.

Perioperative Intravenous Nimodipine Trial

The role of perioperative IV administration of nimodipine, an L-type calcium channel antagonist which is capable of crossing the blood-brain barrier, on peri-operative opioid and anesthetics requirements, pain intensity, opioid-related side effects and early postoperative bowel mobility in patients undergoing surgical treatment for bowel cancer with open radical colectomy remains scarcely explored. A prospective double-blind, randomized controlled trial investigating the effect of perioperative IV administration of nimodipine in patients undergoing open colectomy for cancer treatment is therefore conducted.

Phase III Efficacy and Tolerability Trial of the Fixed Dose Combination of Etodolac 400 mg and Cyclobenzaprine 10 mg Versus Isolated Active Substances in Pain Control After Impacted Third Molar Extraction

This Phase III study will compare the efficacy and tolerability of a Fixed Dose Combination of Etodolac + Cyclobenzaprine versus the isolated drugs in postoperative pain control after impacted third molar extraction.

Blue Light as an Anti-inflammatory and Analgesic Strategy in Thoracic Trauma

The main goal of this clinical trial is to learn if light therapy improves pain and inflammation in adults with painful rib fractures. The main question it aims to answer is: \- Does bright blue light therapy in addition to standard pain treatments improve pain with breathing in adults with painful rib fractures? Researchers will compare participants who receive bright blue light therapy to participants who receive white light therapy and participants who receive only usual lighting conditions to look for differences in their pain control. In addition to their assigned light treatment, all participants will receive standard pain control treatments. Participants will be assigned randomly to one of three groups: one-third will be assigned to bright blue light therapy, one-third will be assigned to bright white light therapy, and one-third will be assigned to usual light only. They will receive their assigned light treatment for 4 hours during the morning/early afternoon for up to 3 days while they are in the hospital. On each day they receive the light treatment and on the day after their final light treatment: * They will be asked twice to rate their pain at rest and with taking a deep breath. * They will be tested to confirm that they are not experiencing delirium, or confusion related to being in the hospital. * Blood samples will be collected to look for changes in inflammation and the circadian clock, the body's natural 24-hour cycle.

The Effect of Perioperative Hydrogen Inhalation on Post-operative Pain and Inflammation Cytokines

To understand the impact of perioperative hydrogen inhalation on post-operative pain control and serum inflammation markers

Relieving Pain and Improving Sleep: Evaluating Topical Pain Relief and Sleep Patches

This minimal risk, randomized, double-blind, placebo controlled Institutional Review Board (IRB)-approved study with functional measurements, will evaluate pain relief and sleep improvement after use of a drug- free, non-invasive patch (FREEDOM or REM Patch; The Super Patch Company Inc.); using validated scales and functional measurement tools along with crossover and control groups within the same subject group not receiving an 'active' patch.

Utility of CYP2D6 Genotyping to Improve the Efficacy and Safety of Tramadol

Randomized clinical trial to evaluate the utility of CYP2D6 genotyping to improve the efficacy and safety of tramadol in the treatment of acute postoperative pain. Phase IV and low-intervention trial To evaluate if the implementation of pharmacogenetics in clinical practice can help to improve the treatment of acute pain, increasing efficacy and reducing adverse reactions. The main evaluation variable: This is a simple study, which does not differ from standard clinical practice and therefore we do not expect early ending of the study.

Developing a Virtual Reality (VR)-Based Prototype for Perioperative Care - a Proof of Concept Study

Preoperative anxiety and acute post-operative pain are common and have been associated with the development of chronic post-surgical pain and longer hospitalisation. Pharmacological interventions to combat anxiety and pain come with their attendant adverse effects. Therefore, non-pharmacological strategies- Virtual Reality (VR) has gained popularity to improve overall the perioperative experience for patients. Our overall aim was to develop and evaluate the use of a VR-based prototype to reduce pre-operative anxiety and post-operative acute pain intensity in our local patient population. Our primary objective was to develop a customized VR mindfulness application incorporating locally relevant scenarios and evaluate its feasibility, acceptability and preliminary associations with changes in perioperative anxiety and pain. Our secondary objectives included evaluating patient satisfaction and preferences for different VR modules.

Virtual Reality for Pain and Fear in Children With Burns

Burn injuries are very painful for children, especially during dressing changes when the wound is cleaned and re-bandaged. This procedure, while necessary, can cause pain, fear, and distress that may make children afraid of future treatments. Virtual reality (VR) is a technology that uses a headset to show an immersive, interactive 3D world. It can distract children from painful medical procedures. This study aims to find out if using VR during burn dressing changes can reduce pain, fear, and behavioral distress in children aged 6 to 12 years. Half of the children will receive standard burn care plus VR distraction during their dressing change. The other half will receive standard care only. The study will take place at the Burns and Plastic Surgery Center, Mansoura University, Egypt. Children will be recruited from both inpatient wards and outpatient clinics. Pain will be measured using a number scale, fear using a faces scale, and distress will be observed throughout the procedure. It is expected that children who use VR will report less pain, show less fear, and display less distress during their dressing changes compared to children who receive standard care alone.

Pectoral Nerve Blocks (PECs) for Cardiovascular Implantable Electronic Device Placement

The purpose of this study is to determine whether administration of a pectoral nerve blocks (Pecs I and II) with 0.25% bupivacaine are more effective as compared to placebo to provide analgesia for cardiac implantable electronic device (CIED) placement in cardiac electrophysiology lab

Prevalence of Pain in Hospitalized Cirrhotic Patients

According to the WHO, pain is an "unpleasant sensory and emotional experience, linked to existing or potential tissue damage, or described in terms suggestive of such damage". It is a legal obligation to evaluate and take care of it (law of 03/04/2022). However, there are still areas where this is not addressed, particularly in cirrhotic patients (Piano V et al. 2023). The global prevalence of cirrhosis increased by 74.53% between 1990 and 2017 (Liu YB et al, 2022, INSERM France file and Zhai M et al. 2021). In France, the prevalence of cirrhosis is estimated to be 200,000 patients (Cohorte Constances 2017; Serfaty 2019). The causes are varied: toxic (alcohol), viral (hepatitis B, C, HIV), genetic (hemochromatosis, primary biliary cirrhosis) but also iatrogenic or linked to a metabolic syndrome, non-alcoholic fatty liver disease. The first symptoms of cirrhosis are fatigue, loss of appetite and weight, nausea and vomiting, discomfort and abdominal pain. More serious symptoms may appear such as depression, confusion, sleep disturbances, edema of the lower limbs, ascites, severe pruritus or jaundice. All of these symptoms can be the cause of the pain. However, to date, there are no studies in France on the epidemiology of pain in patients with cirrhosis (Piano V et al. 2023, Klinge M, et al, 2018). To evaluate the prevalence of pain in cirrhotic patients hospitalized at the Center Hospitalier de la Dracénie in Draguignan. Patients hospitalized at the Dracénie CH with a diagnosis of cirrhosis in its patients will be identified in the various departments by a referring doctor who will have to contact Dr PIANO. The latter, as investigating doctor, will then be able to select the patients meeting the inclusion criteria of the protocol and the informants of the existence of the research. He will explain the study to them in detail, give them sufficient time for reflection before obtaining their oral agreement and giving them the information-no-opposition letter. The research will require a single consultation lasting between 15 and 45 minutes. During the visit, the patient will be asked whether or not they are experiencing pain.

A Randomized Comparison Between 0.67 mcg/kg, 1 mcg/kg, and 1.33 mcg/kg of Perineural Dexmedetomidine for Ultrasound-Guided Infraclavicular Block

This study will compare three different doses of perineural dexmedetomidine 0.67 mcg/kg, 1 mcg/kg, and 1.33 mcg/kg as adjuvants to local anesthetics for ultrasound-guided infraclavicular brachial plexus blocks (ICBs). Our research hypothesis is that 1.33 mcg/kg will provide a 15%-longer duration than 1mcg/kg, which in turn will provide a 15%-longer duration than 0.67 mcg/kg. Since analgesic duration and sensory duration can be influenced by intake of pain medications and surgical trauma to small cutaneous nerves, respectively, we will select motor block duration as the main outcome to better target the action of dexmedetomidine on the brachial plexus.

Intranasal and Intravenous Oxytocin for Analgesia to Noxious Heat Pain

The goal of this research study is to find out how well oxytocin works to reduce pain. Oxytocin will be given intravenously (IV) and as a nasal spray. The study team also hopes to find out if the participants age, weight, or sex effects how well the study drug works. Participants will be exposed to a heater on the skin at a training visit and rate how much pain different temperatures cause. On two separate visits, participants will use a nasal spray and get an IV infusion. After the IV and nasal spray, participants will rate the pain of the same skin heating temperature at various time points for 4 hours.

Brief Postoperative Pain Management Intervention: Meaning Making Amendment

This single-site, two-arm, parallel-group randomized controlled trial will enroll adults undergoing total knee or hip replacement surgery. Two days after surgery, participants will complete a brief guided mindful breathing practice delivered by text message and will then be randomized to receive either personalized meaning-making questions or implementation-focused questions. The trial will evaluate whether personalized meaning-making questions enhance the clinical effects of the mindfulness practice on acute pain, pain unpleasantness, anxiety, desire for pain medication.

Comparison of the Effectiveness of Two Different Methods in Reducing Pain and Anxiety

Aim: This study was conducted to determine the effect of distraction techniques (breathing exercises and stress ball squeezing) applied to adults during blood collection on pain and anxiety. Materials and Methods: The sample consisted of 90 patients who applied for admission to the Physical Therapy and Rehabilitation Department of Turgutlu State Hospital between March 2025 and February 2026, comprising 30 breathing exercise, 30 stress ball, and 30 control groups. Data collection utilised the 'Demographic Characteristics Form', the 'State Anxiety Scale' and the 'Visual Anxiety Scale', the 'Visual Pain Scale'the 'Life Findings Form' to record life and the 'Informed Consent Form' were used . Descriptive statistical methods (number, percentage, median, mean, standard deviation), chi-square, Kolmogorov-Smirnov, Kruskal- Wallis, Wilcoxon, Bonferroni and Friedman were used when evaluating the data.

A Pilot Trial of Disposable Nitrous Oxide Canisters in Providing Pain Control During Burn Dressing Changes

Improvements in burn care have resulted in increased survival. Despite these improved outcomes one of the leading challenges of burn care remains providing adequate analgesia during routine wound care and dressing changes. The traditional use of narcotics is challenging as the therapeutic window between analgesia and suppression of breathing becomes narrow with the intense pain and high doses of narcotics needed for dressing changes.

The Efficacy of Acu-TENS as an Adjunct Analgesic During USG-MVA

Objectives: To prospectively evaluate the potential of acu-TENS to reduce the pain experienced by women undergoing ultrasound-guided manual vacuum aspiration (USG-MVA) and evaluate its safety profile. Hypothesis to be tested: Does the use of acu-TENS reduce pain in women undergoing USG-MVA? Design and subjects: A prospective randomized control trial will be carried out at the Department of Obstetrics and Gynaecology of the Prince of Wales Hospital. Women undergoing USG-MVA for the treatment of early pregnancy loss before 12 weeks of gestation will be randomized to receive acu-TENS (intervention group) or sham acu-TENS (control group) for pain control during USG-MVA. We will recruit 54 participants in each of the two arms, so a total of 108 patients will be recruited. Study instruments: USG-MVA will be performed using a 60ml charged syringe (MedGyn Aspiration Kit) with a flexible curette attached to it. Transabdominal ultrasound during the MVA procedure will be performed using Mindray DC-80A Diagnostic Ultrasound System. Acu-TENS will be performed using MTR+ Myolito Multifunctional Stimulator (MTRP-00003). Main outcome measures: Primary outcome includes pain scores before, during and after USG-MVA. Secondary outcomes include (1) stress levels measured by heart rate, heart rate variability, blood pressure, State Trait Anxiety Inventory (STAI), and salivary cortisol; (2) anxiety level; (3) Surgeon's assessment on the patient co-operation score and patient intraoperative pain, (4) Client Satisfaction Questionnaire (CSQ8) and satisfaction score, and (5) any adverse events of acu-TENS. Data analysis: Data analysis will be performed using the Statistical Packages of Social Sciences for Windows (SPSS, Inc). Expected results: We expect that acu-TENS will result in at least a 35% reduction in pain experienced by women undergoing USG-MVA.