17 Clinical Trials for Various Conditions
The purpose of this study is to: 1. Establish whether ketamine can decrease opioid consumption and modulate the onset of opioid tolerance and prevent opioid-induced hyperalgesia in pediatric subjects, ages 10 years to 18 years, undergoing posterior spinal fusion and instrumentation.
The purpose of this study is to determine if addition of dextromethorphan to a stable dose of methadone in opioid dependent subjects will significantly affect physical and psychological aspects of opioid tolerance.
Peripheral nerve blocks with local anesthetics (LAs) have become an integral part of postoperative pain management particularly for patients undergoing major limb procedures such as such as Total Knee Arthroplasty (TKA). And while postoperative pain management in patients with a history of chronic opioid use may be difficult with systemic opioids because of opioid tolerance, there is anecdotal evidence suggesting that these patients may also be less responsive to LAs. Preliminary data from pre-clinical animal study show that there is a decreased LA potency in blocking sciatic nerve in opioid tolerant rats. And the decrease in LA potency is reversed by the knock-down of the beta4 subunits of Voltage-gated sodium channels along the sciatic nerves, suggesting the opioid induced intrinsic changes in the peripheral nerve as an underlying mechanism for opioid induced loss of LA potency. Study Goals: To determine the extent to which the changes in beta4 subunits of voltage-gated sodium channels are reflected in surgical patients. Experimental Design / methodology: This is a prospective, double-blind, active treatment controlled study. TKA Patients who receive nerve blocks will be grouped according to their history of pre-operative opioid use, and then tested for local anesthetic use for nerve block. Synovial tissues will also be collected for the analysis of beta4 subunits. Subject population: Patients who are scheduled for TKA procedure, and agree to receive peripheral nerve block for postoperative pain control, will be recruited for the study. Patients will participate in one of the three study groups: opioid naive, opioid history and opioid tolerant. 30 patients for each group with a total of 90 patients will be recruited. This study will not only determine the extent to which the preclinical findings are reflected in clinical patients, but also identify the underlying mechanisms that may suggest strategies for more effective post-operative pain management in the growing population of opioid tolerant patients
When narcotic pain medicine, like fentanyl or morphine, is given to adults and children for several days, they often develop a tolerance to the medicine. This means they may need higher doses over time to get the same amount of pain control. When it is time to stop the medicine, the dose has to be decreased slowly so that the patient does not have withdrawal symptoms. Naloxone is a medicine that at high doses can reverse the effects of narcotics. At very small doses it may help prevent tolerance and lessen the severity of withdrawal symptoms. This could mean less narcotic pain medicine is needed over fewer days. The purpose of this research study is to see if giving naloxone to neonates who require narcotic infusions is safe and effective. Safety will be measured by the incidence of side effects. Efficacy will be measured by monitoring for changes in pain and sedation scores and need for more pain medicine.
Recently there has been an increased awareness in the need for adequate sedation and pain control for Pediatric Intensive Care Unit (ICU) patients. Fentanyl is an opioid commonly used in Pediatric ICU patients to decrease pain and increase sedation. Although opioids (e.g. morphine and fentanyl) provide excellent pain relief, they have many side effects including dependence, tolerance and withdrawal. These side effects lead to increased doses in order to maintain pain control and/or sedation. There have been a few adult studies pointing to some possible treatments. For example, giving low dose naloxone along with opioids. Adult studies show that this combination not only decreases the frequency of opioid side effects, but also improves pain control and prevents the development of tolerance. We propose that children who receive low dose naloxone infusions along with fentanyl infusions will demonstrate: 1) decreased total daily doses of Fentanyl, 2) decreased frequency of withdrawal and 3) increased pain and sedation control. In this randomized, blinded prospective trial we will enroll 168 Pediatric ICU patients. Patients will receive either low dose naloxone or placebo simultaneously with their fentanyl infusion. Pain and sedation will be assessed using the Modified Motor Activity Assessment Scale (MMAAS). The fentanyl infusion will be increased to provide adequate pain control and/or sedation. Naloxone infusion will not be adjusted. Approximately 48 hours prior to removal from the ventilator, patients will have their fentanyl infusions decreased while being monitored for withdrawal. Patients showing signs of withdrawal will receive methadone, an opioid taken by mouth. Once off fentanyl, naloxone will be stopped. Patients will continue to be monitored for withdrawal for 4 days or until ICU discharge. If this study works, patients who receive low dose naloxone along with opioid infusions will have less tolerance and dependence and demonstrate less withdrawal. This may cause shorter Intensive Care Unit stays.
Opioids, such as fentanyl, are commonly used in PICU patients to provide comfort and pain control. Opioid tolerance, the need to increase the dose of medication to achieve the same effect,is seen in PICU children who require opioid infusions. Animals and human studies have shown that activation of the N-methyl-D-aspartate (NMDA) receptor is involved in the development of opioid tolerance and that deactivation of this receptor can slow the development of tolerance. Ketamine, an NMDA receptor antagonists, turns off the NMDA receptor. Ketamine is used to provide sedation and anesthesia in children. Its use in inhibiting the development of opioid tolerance has not been tested in children. We aim to determine ketamine's effectiveness in the treatment of tolerance in PICU patients who require fentanyl infusions to treat pain and discomfort . Some physicians have reported using ketamine doses of 0.04mg/kg/hr to 0.5mg/kg/hr to inhibit opioid tolerance. We propose to study the sedative effect, and the metabolism of, three doses of ketamine, 0.1mg/kg/hr, 0.3mg/kg/hr, and 0.5mg/kg/hr. Patients admitted to the PICU, requiring a breathing machine and fentanyl infusion for discomfort or pain control will be enrolled. Patients' age three to eighteen years will be enrolled. Patients will receive a ketamine infusion once their COMFORT scores indicate an adequate sedation/comfort level on their current sedation regimen. The COMFORT score is a validated scale that measures distress in PICU patients. The COMFORT score will be continued for the twelve hours the patient receives the ketamine to test whether the ketamine adds to the level of sedation. Blood samples during and following the ketamine infusion will be taken to determine how ketamine and norketamine (one of ketamine's metabolites) are used in the body. To determine the effect of ketamine on tolerance it must be a ketamine dose that does not cause additional sedation. The goal of this study is to define a non-sedating dose of ketamine and define how it is used by the body. A non-sedating ketamine dose could be added to current sedation regimens allowing us to monitor the development of tolerance without the confusion of added sedation. The data obtained in this study will be used to design a study to further investigate the effect of ketamine on opioid tolerance.
The purpose of this study is to determine the extent to which analgesic tolerance develops in chronic pain patients who are either started on opioids or who receive an increase in pre-study opioid dose level and then observed during long-term (20 weeks) stable opioid therapy. In addition to clinical measures of relief of ongoing chronic pain, estimation of tolerance development will be supplemented by periodic assessment of the anti-nociceptive effects of opioids using the brief thermal sensitization model.
Dual medication (guanfacine and morphine) as a standard treatment for chronic pain.
The main objective study is to compare the use of the cryoSPHERE probe to the standard-of-care method for pain management of patients receiving robotic-assisted thoracoscopic surgery, including reductions in opioid pain medication use and the development of post-surgical morbidity.
The proposed study is a clinical trial, designed to pilot test a Distress Tolerance-Benzodiazepine Discontinuation (DT-BD) intervention for patients on opioid agonist therapy who currently use benzodiazepines. The DT-BD intervention is an adjunctive psychosocial intervention in people seeking to discontinue (BZD) use. The goal of the study is to assess the applicability and feasibility of this intervention through treatment retention and qualitative interviews with four participants who are receiving opioid agonist treatment and who regularly use BZDs.
The current project seeks to explore the use of emergent biosensor technology to detect opioid use. The investigators goal is to recruit 60 opioid naïve patients presenting at the College of Dentistry at UTHSC. Candidate participants must be scheduled for an upcoming dental procedure that will involve subsequent pain management using oral opioid medication. Participants will be consented prior to any study procedures. All participant information from this study will be kept strictly confidential (e.g., no individual data will be shared with the College of Dentistry).
Before starting treatment with XR-NTX, a medication that blocks the positive effects of opioids and helps people stay off opioids, individuals who are dependent on opioids first have to endure a difficult withdrawal process. This study aims to develop and test an intervention to help people who are opioid dependent successfully complete that transition; the investigators will also develop and test a comparison condition aimed at reducing HIV risk behavior.
To access the efficacy of adding diphenhydramine as adjunct to improve sedation and to reduce the amount of standard sedatives used during colonoscopy in patients on chronic opioids.
The investigators propose that inability to tolerate the distress of opioid withdrawal and the negative affect associated with early abstinence are key factors in early illicit opioid lapse and subsequent buprenorphine treatment drop-out. Our intervention aimed at increasing distress tolerance is designed to increase treatment adherence.
Opiates such as morphine are the cornerstone medications for the treatment of moderate to severe pain. Recent evidence suggests that pain patients on chronic opioid therapy become more sensitive to pain (hyperalgesia) over time. There is also a long-standing notion that analgesic tolerance to opioids (habituation) develops during chronic use even though this phenomenon has never been prospectively studied. Our specific aims propose to prospectively test the hypotheses that; 1) Pain patients on chronic opioid therapy develop dose-dependent tolerance and/or hyperalgesia to these medications over time, 2) Opioid-induced tolerance and hyperalgesia develop differently with respect to various types of pain, 3) Opioid-induced hyperalgesia occurs independently of withdrawal phenomena, and 4) Opioid-induced tolerance and hyperalgesia develop differently based on gender and/or ethnicity. This proposed study will be the first quantitative and prospective study of tolerance and hyperalgesia in pain patients and will have important implications for the rational use of opioids in the treatment of chronic pain.
The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. To examine differential acute tolerance development to effects of nitrous oxide in humans.
The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. To examine the lack of acute tolerance development to the subjective, cognitive, and psychomotor effects of nitrous oxide in healthy volunteers.