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NCT ID: NCT03303664 Withdrawn - Pain Clinical Trials

Inpatient Multimodal Path to RecOVEry

Start date: July 11, 2017
Phase: N/A
Study type: Interventional

The goal of the proposed study is to develop and implement a comprehensive strategy to address pain management in the inpatient setting while appropriately managing pain and optimizing patient safety in the inpatient setting. This strategy involves developing a new health Information Technology tool in the Omnicell and electronic medical record, implementing a "menu" of pain management and relaxation strategies, and developing educational materials for staff and patients to change the culture of pain management.

NCT ID: NCT02953691 Withdrawn - Pain Clinical Trials

Exploring the Impact of Perioperative Galacto-Oligosaccharides (GOS) on Stress, Anxiety and Cognition

Start date: June 9, 2017
Phase: Phase 2
Study type: Interventional

The overall objective of this proposal is to explore the association between the administration of the prebiotics GOS (trade name: Bimuno Travelaid; generic name:B galacto-oligosaccharides) with pain, anxiety, and cognitive function in the perioperative period. The investigators' central hypothesis is subjects who consume GOS in the perioperative period will demonstrate lower levels of salivary cortisol before, during, and after their operative procedures. In addition, the investigators expect subjects who consume GOS to have lower perceived levels of anxiety during the perioperative period. Finally, the investigators hypothesize that subjects who consume perioperative GOS will perform better on tests of cognition in the postoperative period. Such a finding would be beneficial in that administration of GOS in the perioperative period offers a safe and inexpensive adjunct to current medical management of perioperative anxiety.

NCT ID: NCT02844348 Withdrawn - Pain Clinical Trials

Impact of Hypnosis on Pain Management During Dialysis on Patients Suffering From Arterial Disease

Start date: February 2016
Phase: N/A
Study type: Interventional

A chronic renal disease can results in the development of cardiovascular complications, including chronic arterial disease ; but a cardiovascular disease may be from a kidney malfunction that will end in end stage renal disease (ESRD). Two thirds of the chronic hemodialysis patients taken in charge in Grenoble in the last years suffered from an arterial disease at a symptomatic stage. Breakthrough pain can appear during the hemodialysis sessions. These sessions induce sudden hemodynamic changes and a peripheral vasoconstriction reaction that increases in particular all pain phenomena related to chronic low limbs ischemia. Therefore, patients have to face pain, sometimes chronic but also breakthrough pain, during the dialysis sessions, in all its dimensions. The analgesic balance through the classical drug treatment is extremely complex, as they are both at risk of overdose and of partial effectiveness. Strict medical treatment remains unsatisfactory, as it takes into account only the expressions of symptoms during dialysis sessions, when most of the time pain is already installed and analgesic treatment is not completely effective. The combination of classic pharmacological treatment with hypnosis, already used in other indications (chronic pain, analgesia, depression and anxiety), may mitigate the painful feeling on patients suffering from arterial disease during the dialysis sessions, with a beneficial impact on their overall quality of life. There is also evidence to suggest that hypnosis may be more effective treating neuropathic or vascular pain, those experienced by our patients, than musculoskeletal pain, like back pain. Hypnosis is a mind-body approach focused on the subject, and not on the disease or the act of dialysis. It can be described at the same time as a modified state of consciousness and a particular intersubjective relation between a practitioner and his patient. The practice of this kind of hypnoanalgesia by the nurses is particularly relevant in hemodialysis, as the trust developed during regular chronic treatment can become an asset to shorten the induction phase and help to install this intersubjective relation. The high incidence of this complication, the difficulties of current pain management and the impact on everyday life for the patients, justify the choice of this approach, where more further research is needed.

NCT ID: NCT02828059 Withdrawn - Pain Clinical Trials

Continuous Wound Infiltration for Diminution of Post-surgery Pain After Caesarean Section

Start date: August 2016
Phase: N/A
Study type: Observational

A medical approach that warrants continuous and reliable local administration of non-opioid analgesic drugs might substantially improve post-surgery pain management in CS, while decreasing the necessity of staff-dependent invasive procedures and the probability of untoward effects following systemic drug exposure. ReadyfusOR® is a formulation comprising a Ropivacain-loaded single-use pump which has been approved for regional application of the analgesic drug, also comprising obstetric interventions. There is, however, scarce scientific information on the efficacy and benefit of this anesthetic drug formulation for pain management following CS by means of continuous wound infiltration.

NCT ID: NCT02815111 Withdrawn - Pain Clinical Trials

Evaluation of Ketamine and Multi-modal Analgesics

Start date: July 2016
Phase: N/A
Study type: Observational

The purpose of this research study is to see if pain can be better controlled with fewer side effects. The new drug regimen will study several different medicines that have different ways of treating pain.

NCT ID: NCT02542098 Withdrawn - Pain Clinical Trials

Safety, Pharmacokinetics (PK), and Effectiveness of Hydrocodone Bitartrate (HYD) Extended-Release Tablets in Children

Start date: January 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and effectiveness of Hydrocodone Bitartrate (HYD) tablets in children with moderate to severe pain requiring around-the-clock opioid analgesics.

NCT ID: NCT02540512 Withdrawn - Pain Clinical Trials

Acupuncture for Pain in the Emergency Department

Start date: July 27, 2017
Phase: Early Phase 1
Study type: Interventional

The purpose of the study is to test auricular (ear) acupuncture for the acute management of patient pain in the Emergency Department as an alternative and adjunct to standard medical treatment. Currently, physicians who practice medicine here in the United States only have pharmacological intervention at their disposal as the only available treatment tool they have for the treatment and management of pain, and as a result, painkiller misuse, overdose, and death has become the leading health epidemic in America. American healthcare is in desperate need of alternative and safer ways to prevent prescription painkiller overdoses and to better manage pain. If prescription painkiller dependencies can be avoided at the source, potentially many lives and healthcare dollars can be saved. Acupuncture is an alternative treatment that has been effectively used to treat pain for thousands of years in countries around the world. The National Institutes of Health (NIH) and the United Nations World Health Organization (WHO) have stated that acupuncture is a safe and effective treatment for the management of pain. Supported by many studies illustrating seventy-five to ninety-nine percent effectiveness in treating pain with an instantaneous drop in pain by twenty-five to eighty percent, acupuncture appears to be the safest and most effective option available to manage pain syndromes in the emergency department. Auricular acupuncture has demonstrated beneficial effects to reduce acute and chronic pain intensity. Specifically, for the thesis of this clinical trial, the investigators hypothesize that auricular acupuncture can be an effective alternative and/or adjunct treatment tool in the civilian emergency department for the acute management of pain. In order to test the safety and efficacy of using auricular acupuncture in the emergency department, people presenting to the emergency department with pain who are willing to participate in the study will be randomized into three separate groups: 1. Standard medical group (tape on ear + standard medical drug) 2. Standard medical group plus auricular acupuncture (acupuncture + standard medical drug) 3. Auricular acupuncture group (acupuncture + placebo pill) The design of these groups will allow the investigators to best test the efficacy of auricular acupuncture versus the placebo effect and standard medical care as well as an adjunct to standard medical care. To accomplish the objective of this proposal, the investigators will pursue the following specific aims: Specific Aim 1: To prove the efficacy of auricular acupuncture over a placebo group in the management of pain syndromes. By having the acupuncture group and sham acupuncture group, the investigators will be able to effectively compare the difference in pain levels with a placebo-group. Specific Aim 2: To prove that auricular acupuncture is an effective alternative and/or adjunct to standard medical care in the Emergency Department. By testing the efficacy of acupuncture in conjunction with standard medical treatment, the investigators expect to see a potentiation of analgesic effects, and this will be noted by an increased reduction in pain between the standard medical plus acupuncture group versus the standard group and acupuncture group. Specific Aim 3: To prove that auricular acupuncture as an effective pain management alternative that decreases short-term prescription painkiller dependency. Through a series of follow up questionnaires and a medication diary that the investigators will give to the patient prior to discharge, the investigators will track the patient's need and use of additional pain medications post treatment. These surveys will give a good indication as to the effectiveness of auricular acupuncture to reduce a patient's dependency on painkiller drugs in the short-term setting.

NCT ID: NCT02521480 Withdrawn - Pain Clinical Trials

Determination of Analgesic Effect From One Transcranial Magnetic Stimulation(TMS)Treatment Following Vaginal Reconstructive Surgery.

Start date: July 2015
Phase: N/A
Study type: Interventional

To determine whether real TMS is more effective than sham TMS in reducing pain following surgery

NCT ID: NCT02390440 Withdrawn - Pain Clinical Trials

Exparel for Pain Control During Care of Rib Fractures

Start date: April 2015
Phase: Phase 4
Study type: Interventional

This study is looking at a novel therapy of numbing medication injected directly around the fracture site. The purpose of this study is to determine if the study medication, EXPAREL®, is a viable alternative to current therapies for rib fractures.

NCT ID: NCT02378740 Withdrawn - Pain Clinical Trials

Ketamine in Patients Undergoing Anterior Cervical Discectomy and Fusion

Start date: April 2015
Phase: Phase 4
Study type: Interventional

Ketamine is an IV anesthetic with non-opioid analgesic properties that has been shown to reduce pain while also decreasing intraoperative and postoperative opioid requirements when used in subanesthetic doses after a variety of surgical procedures.1 It is a non-competitive antagonist of N-methyl-D-aspartate (NMDA) receptors, and by this mechanism ketamine is believed to block the development of central sensitization and wind-up phenomenon,2,3 which may be helpful in preventing acute and chronic pain after repetitive insults. In a systematic review of ketamine as an adjuvant to opioid analgesia, low-dose ketamine was found to be a useful addition to standard postoperative pain management practice with opioids in 54% of studies.1 The studies that did not show a significant effect were in patient populations with low opioid requirements. Therefore, it has been suggested that future clinical trials be focused on patient populations with significant post-operative pain, such as spine surgery and major orthopedic surgery not amenable to regional analgesia, and postoperative pain in patients on chronic preoperative opioid therapy.1 There are few studies examining outcomes after ketamine in the perioperative period after spine surgery. Loftus et al randomized patients with a history of chronic preoperative opioid use (i.e., daily opiate use for at least 6 weeks) to intraoperative ketamine versus placebo and found a 30% reduction in morphine consumption at 48 hours and an approximately 25% reduction in visual analog scale (VAS) pain score in the post anesthesia care unit and at 6 weeks.4 Although this study provided evidence that there may be reduction in long-term postoperative pain, additional studies are needed to provide evidence that this effect is sustained beyond the 6-week period. We are interested in examining ketamine more closely in spine surgery because this patient population experiences significant postoperative pain that may be difficult to control due to preoperative opioid use (i.e., opioid tolerance). The investigators chose to study ACDF patients specifically because it is a common spine procedure throughout the United States and the patients have significant opioid requirements postoperatively. In a study examining the effects of the low dose ketamine for postoperative IV PCA fentanyl after cervical and lumbar surgery, patients in the placebo group (and thus only receiving fentanyl PCA) reported mean VAS scores of 4-5 with movement while receiving opioids.5 Further, while previous studies have shown an opioid-sparing effect of ketamine as measured by opioid consumption and a decrease in pain as measured by VAS scores, no study to our knowledge has examined quality of recovery after intraoperative ketamine infusion. The Quality of recovery (QoR-40) score was developed by Myles et al to assess quality of recovery after anesthesia based on forty questions in five dimensions,6 and this score has been shown to be a reliable and valid outcome for patients undergoing both spine and cranial surgery.7 QoR-40 is also of interest because it should be able to provide a global assessment of the possible benefit or harm of using ketamine in patients by simultaneously characterizing the detrimental side effects as well as the positive benefits of ketamine when used as an infusion at subanesthetic levels (studies thus far have shown that there are minimal side effects such as hallucinations).1,4 Significance: Previous studies have shown an opioid-sparing effect of ketamine, however further research is warranted in patients whose pain may be difficult to control and whether this effect is sustained. ACDF patients experience significant pain post-operatively, and ketamine may improve their quality of recovery due to its opioid-sparing effects and prevention of chronic pain. Further, patient centered outcomes as measured by the QoR-40 have not been reported in the literature when ketamine, or other opioid sparing anesthetics, have been administered. This study will not only determine if the "moderate" dose of ketamine is beneficial or detrimental to the recovery of patients but also whether it can improve long term patient function, presumably by decreasing central pain sensitization. In addition, this study will set the stage for further RCT's examining other analgesic strategies in cervical spine surgery patients (i.e., intraoperative lidocaine infusions, volatile anesthetic vs. propofol as the primary hypnotic, COX-2 inhibitors, pregabalin, etc.). The overall goal would be to develop a multi-faceted regimen that decreases the postoperative inpatient opioid requirements of these patients and may facilitate long term recovery. The research questions:Does ketamine improve the quality of recovery at 24 hours after anterior cervical discectomy and fusion (ACDF)? The hypothesis: the investigators hypothesize that ketamine will improve the quality of recovery after ACDF surgery