27 Clinical Trials for Various Conditions
Children with chronic diseases, particularly those who have received transplantation (e.g. cardiac, renal, or liver) are a population who undergo frequent painful procedures, such as venipuncture multiple times per week. There is currently no standard of care for pain reduction during venipuncture for pediatric patients having blood drawn in phlebotomy as an outpatient. The study aims to determine the efficacy of distraction in reducing procedural pain and distress associated with venipuncture in pediatric post-transplant patients.
The purpose of this study is to compare the effect of Synera patch versus LMX-4 cream and placebo on the level of pain, observed distress, difficulty of venipuncture and skin side effects in children undergoing intravenous blood draw in the emergency setting or the phlebotomy lab.
This study compares the efficacy of the Synera patch with Eutectic Mixture of Local Anesthetics (EMLA) as a topical anesthetic for venipuncture in pediatric patients.
A direct comparison study of blood samples collected using the Tasso+ device and venous blood samples in patients with elevated alanine transaminase (ALT).
This is a randomized non-blinded trial evaluating the effect of virtual reality goggles on perceived pain and anxiety scores during venipuncture on hospitalized children ages 5-21. We will randomized patients to either standard of care (including Lidocaine 2.5%/Prilocaine 2.5% cream as a topical anesthetic 60-240 minutes prior to venipuncture) or standard of care plus virtual reality goggles.
To evaluate the impact of using virtual reality, VR, game playing on successful completion and reduction of distress and pain in pediatric venipuncture, and to increase adherence in obtaining the desired blood volume.
The purpose of this research study is to see if factor levels and inhibitor levels in Hemophilia A and B subjects are accurate when they are drawn from a central venous line (CVL) instead of from a peripheral stick.
1. Determine if there is any difference between the whole blood clotting time results obtained from blood drawn from indwelling catheters and direct venipuncture 2. Determine the intra-subject variability in both procedures
Synera, which is a heated topical patch containing both lidocaine and tetracaine, is intended to reduce the pain associated with venipuncture and superficial dermatologic procedures by numbing the skin. This study will test the effectiveness of the Synera lidocaine/tetracaine patch when administered for 30 ± 5 minutes to provide dermal anesthesia in adult oncology patients undergoing venipuncture as part of their care, for treatment or diagnostics (laboratory or imaging). Compared to the use of the placebo patch, this study hypothesizes that the difference of 1 cm on the 0-10 visual analogue scale (VAS) will be observed 30 minutes after the use of the Synera patch. Pain intensity will be assessed by a 0-10 VAS
To determine the efficacy and safety of vapocoolant spray (Pain Ease Medium Stream) in decreasing the pain of venipuncture ("blood draw")
To measure and compare pain associated with venipuncture and peripheral intravenous catheter insertion among pediatric emergency department patients randomized to treatment with one of three different pain-reduction strategies: J-Tip® jet injection of 1% buffered lidocaine, J-Tip® jet injection of sterile saline, or application of 4% lidocaine topical cream. The investigators hypothesize that J-Tip® jet injection of 1% buffered lidocaine will provide superior local anesthesia compared to saline or lidocaine cream.
The purpose of this study is to evaluate the effectiveness of administering Lidocaine and Epinephrine using an iontophoretic device treatment to provide local anesthesia to healthy adult volunteer subjects undergoing venipuncture.
The purpose of this study is to evaluate the amount of anxiety and pain felt by children during procedures that require a needle stick after using a topical anesthetic or placebo cream.
The purpose of this research was to estimate feasibility of an aromatherapy pain management intervention to reduce pain and distress caused by venipunctures in a pediatric population. The feasibility of the use of aromatherapy essential oil lavandula angustifolia for pain management intervention (Treatment Group) was compared to placebo aromatherapy with jojoba oil (Placebo Control Group) and to the current standard of care, which is no oil during a venipuncture (Standard of Care Control Group). Primary measured outcomes were assessed using a double-blind randomized design. The physiological measure of heart rate was taken over the course of four minutes at three different intervals to note the pattern of change that occurs during anticipatory anxiety resulting from the impending procedure, the procedural pain experienced during the venipuncture, and the residual fear common after completion of the venipuncture procedure. The Visual Analogue Scale (VAS) for pain and the Hospital Fears Rating Scale (HFRS) were administered to measure subjective pain and anxiety. Participants (N=21) were recruited from the Laboratory Medicine Unit of Children's National Health System. Feasibility was estimated based on the ability to inhale the full dose of oil without adverse effects and and ability to inhale the full dose within the ten-minute time frame. This study analyzed the effect of the aromatherapy pain management intervention, lavandula angustifolia aromatherapy, on the stress response of a pediatric population through observation of physiological and psychological indicators of pain and distress, in order to learn more about the pain and anxiety experienced during venipuncture and the use of aromatherapy to decrease pain and anxiety during venipuncture.
Peripheral intravenous cannulation (PIVC) is one of the most common interventions in medical practice. Venous dilatation is helpful for successful PIV placement. Several techniques include hot pack application, tourniquet, massaging, and tapping over the vein to increase vein caliber described in the literature. However, none of them has been rigorously studied. Therefore, there is still no 'best practice' on how to effect vein dilation in a standard way. This study aims to investigate the effect of standardized tapping on venous dilatation with a massage device compared to manual non-standardized tapping and define a standard tapping technique using a device. In this study, the investigators also aim to investigate the effect of tourniquet application with and without vein tapping effect on peripheral vein caliber as determined by ultrasound measurement.
Adult patients aged 18-50 undergoing blood draw for routine lab evaluation will be randomized to a control group or experimental group to assess if the use of virtual reality reduces procedural pain (primary outcome) and procedural anxiety (secondary outcome) during venipuncture.
Background: Malaria is a serious infection caused by a parasite. People get malaria when an infected mosquito bites them. Malaria can cause major health and social problems in places were malaria is common, such as Africa but can also affect travelers who have never been exposed to malaria. Researchers at the NIH want to find a safe and effective malaria vaccine, antimalarial drugs, or prevention regimen. To do this, healthy volunteers are recruited under a general screening study in order to see if are qualified to join a future malaria study. Objective: To screen healthy volunteers to see if they are eligible to join investigational malaria studies. The studies will be trials of investigational antimalarial drugs, malaria vaccines, or prevention regimens. They may also involve controlled human malaria infection trials. Eligibility: Healthy people ages 18 50 Design: Participants will first be prescreened by phone. Participants will be screened with: Medical history Physical exam Blood and urine tests Participants may go more than 1 year without joining a clinical trial. If this happens, they may be re-contacted to see if they still want to be part of this screening protocol. Those who still want to participate and have had relevant medical changes will be rescreened.
This study looks at the use of Jet Injection Lidocaine (J tip) for pain during blood draws in children ages 6 and younger. The investigators will use video observation of patients to asses their pain during lab draws using either 1) Jet Injected lidocaine ( J tip) 2) Pain Ease spray 3) Pain Ease spray plus the J tip noise.
The purpose of this study is to determine whether co-application of a functional microarray of needles (FMA) speeds the rate at which topical anesthesia is provided. A secondary goal is to determine whether the depth of anesthesia is enhanced.
Background: * It is not fully understood why prostate cancer in some men becomes androgen-independent (no longer responds to anti-androgen medication), but genetics likely plays an important role. * Genes contain the hereditary information that is passed down from parents to children. Although everyone has the same set of genes, individuals can have different forms of the same gene. * Differences in genes may explain, at least in part, why some people develop a more aggressive form of prostate cancer than others. Objectives: -To obtain blood samples from patients with prostate cancer to try to identify gene differences associated with progression to the androgen independent state. Eligibility: -All participants participating in NCI prostate cancer protocols. Design: * Participants with prostate cancer are evaluated in the NCI s Medical Oncology Clinic. * Blood samples are collected at the initial visit or at follow-up visits. * DNA (genetic material) and white blood cells are extracted from these samples to be used for genotyping and establishment of cell lines. * Gene variations are correlated with prostate cancer prognosis and prognostic indicators.
A vibrating cold pack placed proximal to the site of venipuncture will decrease the pain of cannulation when compared to vapocoolant spray.
Hypothesis: The first attempt success rate for peripheral IV insertion for children with difficult IV access (difficult IV access \[DIVA\] score ≥ 4) by nurses using the VeinViewer guided technique is better than conventional method of IV placement. Specific Aims: 1. To investigate if use of the VeinViewer can improve the success of peripheral IV placement in children with difficult IV access 2. To validate the DIVA score Design: Prospective randomized controlled trial/Convenience sample Subjects: Children (0-18) presenting to the emergency department who require an IV as determined by examining physician and with a DIVA score ≥ 3 during times when VeinViewer machine is available and a VeinViewer trained participating nurse is on duty. Variables: Outcome Variables: First IV attempt success rate Predictor Variables: IV technique used, other potential modifiers (age, weight, height, skin shade, indication for IV, history of prematurity and, vein visibility/palpability after tourniquet) Methods: Subjects who meet inclusion criteria will be randomized to either conventional IV technique or VeinViewer guided technique. The nurse will attempt the IV depending on the randomization. Success or failure on first IV attempt will be recorded. If unsuccessful, other attempts will be tried until a successful IV is placed or the physician decides to give an alternative therapy that does not need IV access. Statistics: A chi square test will be used to compare the proportion of subjects with successful first attempt IV placement using the VeinViewer technique to that using the conventional method with 95% confidence interval. We, the researchers, will look at the median number of attempts to place an IV in each of the groups. Logistic regression will be performed to test for independent associations. Information collected during the study will also be used for validation of the DIVA score. Risks: No extra risks are expected above that of receiving a standard IV. The standard risk of bleeding, bruising, pain, and infection will be possible regardless of technique used. The VeinViewer does not expose the patient the ionizing radiation. The use of the VeinViewer technique may increase the time need to place an IV in. Potential Benefits: With this study, we, the researchers, hope to improve the success rate of children with difficult IV placement in the Emergency Department.
Background -NCI-Frederick scientists performing in vitro studies involving human specimens have a need for a reliable and consistent source of samples which protects the donor from research risks. Objective -The purpose of this protocol is to establish a centralized repository for the collection and distribution of samples (either blood, buccal mucosal cells, semen, urine, or nail clippings) from paid, healthy volunteer donors for in vitro research conducted by NIH investigators located at NCI-Frederick and Ft. Detrick. Research will include, but are not limited to, genotype analysis, immune function studies, drug screening, vaccine development, method development, quality control testing of reagents, and propagation of infectious agents, including HIV. Eligibility: Healthy NCI-Frederick employees and other NIH staff located at Ft. Detrick will be recruited. Potential donors will be excluded if screening indicates exposure to HIV, HTLV, Hepatitis C or Hepatitis B virus infection. Study Design: Investigators requesting to participate to the Research Donor Program (RDP) by receiving samples for research use will be required to submit a written memo of request, briefly describing the nature of the research and providing assurance that samples provided through this protocol will be used solely for in vitro research. These Investigators will receive samples that will be either anonymous or coded, depending on the specific need. Codes will be securely maintained and under no circumstances will donor identity be released to Investigators. Donors will receive financial compensation for their time, discomfort and inconvenience according to an established schedule; compensation for blood donation is based on the volume donated.
We are studying virologic and/or immunologic parameters of HIV infection and other infectious or non-infectious immune deficiency diseases in order to better understand the pathogenesis of HIV. Because of the lack of an adequate animal model it is generally necessary to utilize human peripheral blood cells for studying aspects of either in vivo or in vitro HIV infection. We wish to be able to continue to elucidate many pathogenic aspects of HIV infection in relation to other infectious or non-infectious immune regulation and dysregulation using human peripheral blood mononuclear cells as a model.
Minor needlestick procedures often cause significant pain and distress in pediatric patients yet interventions to reduce pain are used infrequently. ALGRX 3268 is a novel, single-use, prefilled, needle-free product that immediately delivers powdered lidocaine into the epidermis and provides local analgesia in 2-3 minutes. The purpose of this phase III, prospective, randomized, double-blind, placebo-controlled study is to investigate the efficacy, safety and tolerability of ALGRX 3268 versus placebo in pediatric patients aged 3 to 18 years undergoing venipuncture or peripheral venous canulation procedures. The trial will enroll approximate 504 evaluable subjects at centers located in the US.
Minor needlestick procedures often cause significant pain and distress in pediatric patients yet interventions to reduce pain are used infrequently. ALGRX 3268 is a novel, single-use, prefilled, needle-free product that immediately delivers powdered lidocaine into the epidermis and provides local analgesia in 2-3 minutes. The purpose of this phase III, prospective, randomized, double-blind, placebo-controlled study is to investigate the efficacy, safety and tolerability of ALGRX 3268 versus placebo in pediatric patients aged 3 to 18 years undergoing venipuncture or peripheral venous canulation procedures. The trial will enroll approximate 504 evaluable subjects at centers located in the US.
Minor needlestick procedures often cause significant pain and distress in children, yet interventions to reduce pain are used infrequently. ALGRX 3268 is a novel, single-use, prefilled, needle-free dispenser that immediately delivers powdered lidocaine into the epidermis and provides local analgesia in 2 to 3 minutes. The purpose of this prospective, randomized, double-blind, and placebo-controlled trial is to determine the efficacy and tolerability of ALGRX 3268 in children aged 3 to 18 years undergoing venipuncture. The trial will enroll a total of 306 children aged 3 to 18 years scheduled to undergo venipuncture of the back of the hand at a single study center.