Active clinical trials for "Pain, Procedural"

The study will investigate possible effects of music therapy as an adjunct in an invasive cardiac procedure where infected or broken pacemaker leads, or leads from implantable cardioverter-defibrillators are removed from inside the heart through the vein. The procedure is performed in local anaesthesia with the patient awake. Analgesic and anxiolytic drugs are given at the start of the procedure, and repeated if needed. In spite of the drugs, most patients will experience som degree of pain and/or anxiety and increased stress during the procedure. The music therapy intervention contains individually facilitated music listening and coping techniques, aiming to regulate stress responses. The music listening and guidance is provided by a certified music therapist before, during and after the invasive procedure.

The uterine fibroid embolization (UFE) procedure is a treatment option for abnormal heavy menstrual bleeding and/or bulk symptoms associated with uterine fibroids and adenomyosis. Post UFE procedural pain and nausea are expected events. These symptoms are treated with current standard of care medications, including opiates. Intra procedure pain medications include midazolam, fentanyl and hydromorphone. Some centers include nonsteroidal anti-inflammatory medications (NSAIDS), including oral ibuprofen and IV ketorolac. Post procedural pain control is centered on a hydromorphone patient-controlled analgesia (PCA) infusion pump, as well as a NSAID regimen. Intra procedure and post procedure nausea control medications include a transcutaneous scopolamine patch and IV anti-nausea medications such as ondansetron and prochlorperazine. This study is being conducted to compare two new medications for pain, IV ibuprofen and IV acetaminophen, administered for 24 hours following UFE. The primary safety objective of non-inferiority will be met and the primary efficacy objective of superiority, decreased pain and nausea, will be accessed when compared to current standard of care regimens. This is a 4 arm, double blind, randomized, controlled study. All patients will receive standard of care baseline pain medications, including IV midazolam, fentanyl and hydromorphone intra procedure, followed by a hydromorphone PCA infusion pump post procedure. The 4 arms will include: [ Arm 1] IV ibuprofen/IV placebo, [Arm 2] IV acetaminophen/IV placebo, [Arm 3] IV ibuprofen/IV acetaminophen, and [arm 4] IV placebo/IV placebo. These medications will be given during the procedure and extended over a 24 hour stay. Arm 4 (IV placebo/IV placebo) would replicate current standard of care, and therefore will include IV push (IVP) ketorolac, which would be given at the end of the procedure and be continued every 6 hours for the 24 hour stay. An IVP of saline will be given as a control every 6 hours for the 24 hour stay to arms 1, 2 and 3. Pain and nausea will be measured at intervals prior to the procedure, throughout the stay and at 2 weeks post procedure.

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 study was conducted as a parallel group randomized controlled in order to determine the effects of dry heat and dry cold application before blood collection in school-aged children (7-12 years old) on pain, anxiety and fear levels. Participants were randomly assigned to experiment 1-dry hot application group, experiment 2-dry cold application group and control group. In Experiment 1-Dry Heat Application group, a dry heat of 42°C was applied to the determined area with an electrical heating pad for 5 minutes before blood sample was taken. In Experiment 2-Dry Cold Application group, dry cold was applied to the area determined with a gel pad for 3 minutes before blood sample was taken. In the Control group, blood sampling was performed according to the clinical routine, and no heat or cold application was made.

The overall aim of this study is to investigate the feasibility, acceptability, preliminary effectiveness and sustainability of parent-targeted interventions for pain management during vaccination of infants. To achieve the goal, a two-phase pilot randomized control trial is planned. Study one, currently in the data collection phase, aims i) to evaluate the feasibility and acceptability of data collection tools, participants' recruitment procedures and implementation process of parent-targeted interventions prior to infant vaccination at two, four, or six months. ii) to evaluate the preliminary effectiveness of parent-targeted interventions prior to infant vaccination in promoting the use of pain management strategies during vaccinations of infants at two, four, or six months. iii) to identify the parent's knowledge, use, intention and recommendation to use the recommended pain management strategies, and facilitators and barriers influencing the implementation of the parent-targeted interventions during vaccinations of infants at two, four, or six months. Methods. This study is a prospective multi-faceted two-armed pilot randomized control trial (RCT). a pilot randomized control trial. The participants are parents of infants, recruited before the infants receive their 2, 4, or 6- month vaccinations, who responded to the online invitation and consent to participate in this study. Parents living in Canada and prior to the infant receiving one of the three vaccinations were invited to participate through an online recruitment process. A sample of 50 parent/infant dyads in each group of control and intervention is estimated to be sufficient to achieve the study's goals. The outcome measurements are being done by five brief study questionnaires; Brief information of the study goals and the researchers' affiliation followed by a hyperlink to the survey were posted on different online platforms. Eligible parents of infants who respond to the study invitation are being randomly allocated to 1 of 2 groups (Intervention and control). There are two interventions in the study one being compared: 1) Be Sweet to Babies Videos and Pamphlet; and 2) Be Sweet to Babies Videos, pamphlet, and MIAS&Q. After the intervention, the impact of the vaccination pain management video and brochure followed by MIAS&Q questions are being evaluated by a brief online survey exploring the use of pain management (breastfeeding or sucrose and upright secure holding) during infants' vaccination in both groups. Following that, the opinion of parents about the understandability, applicability, feasibility, and acceptability of this study are evaluated. All data are being collected electronically using REDCap survey tool. SPSS version 23.0 (SPSS Inc, Chicago, Illinois) will be used to perform all descriptive and inferential statistical analyses. NVivo version 11.0 (Qualitative data analysis Software; QSR International Pty Ltd) will be used for content analysis and descriptive statistical analysis and thematic analysis will be used for the analysis of the qualitative data.

This is a prospective study to assess the utility of Lidocaine Hydrochloride 2% gel enema (Hi-Tech Pharmacal Co., Inc.) in reducing post-procedural pain after endoscopic band ligation of internal hemorrhoids. Briefly, patients will be consented prior to entry into the study. During the endoscopic band ligation procedure, patients will be blindly placed into the treatment arm or control arm. The treatment arm will receive 15 ml enema of lidocaine gel immediately upon cessation of the procedure. In the placebo arm, oral pain medications will be provided. Researchers will assess pain following the procedure at 1 hour, 24 hours and 48 hours via telephone call. Another telephone call will be performed at 72 to 96 hours to assess any side effects of the medication.

Preterm infants undergo early separation from parents and are exposed to frequent painful clinical procedures, with resultant short- and long-term effects on their neurodevelopment. We aimed to establish whether the mother's voice could provide an effective and safe analgesia for preterm infants and whether endogenous oxytocin (OXT) could be linked to pain modulation. Twenty preterm infants were exposed to three conditions-mother's live voice (speaking or singing) and standard care-in random order during a painful procedure. OXT levels (pg/mL) in saliva and plasma cortisol levels were quantified, and the Premature Infant Pain Profile (PIPP) was blindly coded by trained psychologists.

This is a two centre two-arm randomised controlled interventional trial. We aim to determine whether parental touch prior to a painful clinical procedure provides effective analgesia in neonates.

The study will be conducted with the randomized controlled experimental method. The children who attended the pediatric emergency department will divide into two groups via randomization in the computer environment. After the randomization, children in the experimental group will play with finger puppets under the direction of the researcher during venipuncture. On the other hand, no application will perform on the children in the control group during the venipuncture. The parents will also be found next to their children in both groups during the procedure.

Premature neonates admitted to the neonatal intensive care unit (NICU) require up to several hundred procedures during their hospitalization. Many of these are tissue-damaging procedures (TDPs) that cause pain. Through our NIH funded research, we made the novel observation that exposure to a single TDP can significantly increase ATP utilization and oxidative stress, as evidenced by increased plasma levels of hypoxanthine, uric acid and malondialdehyde in neonates exposed to TDPs as compared to controls (no TDP). Because neonates are exposed to numerous TDPs, it is relevant to explore the energy costs of repeated exposures to painful procedures, an important information that is currently not known, as the effect of this cumulative metabolic dysfunction could result in potentially treatable or preventable cell injury. Oral sucrose analgesia is frequently given to relieve procedural pain in neonates on the basis of its effect on behavioral and physiological pain scores. However, we found, through our prospective, randomized, double blind study funded by NIH, that although oral sucrose significantly reduced pain scores, its administration before a single TDP (heel lance) significantly increased ATP utilization. This is evidenced by higher plasma concentrations of hypoxanthine and uric acid in neonates given sucrose compared to control neonates (no TDP, no sucrose) or neonates just given a pacifier. These novel findings raise concern because preterm neonates have limited ATP stores and are susceptible to cell injury due to ATP depletion. In addition, it raises the relevant concern: If a single dose of oral sucrose can alter ATP metabolism, what are the effects of exposure to multiple doses of oral sucrose? More importantly, what is the effect of multiple TDPs and/or multiple oral sucrose dosages on ATP utilization, oxidative stress and cell injury? This application will also explore the effect of 30% oral glucose, another sweet solution currently used to relieve pain, on ATP metabolism. In this study, we will test the general hypothesis that exposure to multiple TDPs and/or multiple doses of oral sucrose analgesia compared to oral glucose or standard care, alter biochemical markers of ATP utilization, oxidative stress and cell injury. We will use a prospective randomized clinical research design to test this hypothesis during days of life 3-7 of human premature neonates. Increased ATP utilization will be quantified by concentrations of hypoxanthine, xanthine and uric acid measured using HPLC. Oxidative stress will be quantified by concentrations of allantoin using gas chromatography/mass spectroscopy, and cell injury will be quantified through urinary concentration of intestinal fatty acid binding protein, an early marker of enterocyte injury. Data from this application will provide insight into the cellular and biochemical effects of repetitive and accumulated TDPs and/or multiple doses of oral sucrose. With this knowledge, we will propose and test innovative strategies that will not only decrease pain but also will prevent cell injury or cell death.