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Analgesia clinical trials

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NCT ID: NCT01789606 Completed - Analgesia Clinical Trials

Self-Selection and Actual Use Trial of Ibuprofen 600 mg Immediate Release/Extended Caplet

Start date: September 2012
Phase: Phase 3
Study type: Interventional

A self-selection and actual use trial to evaluate the extent to which consumers will appropriately select and use the 600 mg immediate release/extended release caplets and comply with dosing instructions.

NCT ID: NCT01694745 Completed - Pain Clinical Trials

EUROpean Pain Audit In Neonates

EUROPAINsurvey
Start date: October 2012
Phase: N/A
Study type: Observational

EUROPAIN Survey is an epidemiological study aimed at assessing current clinical practices regarding the use of sedative and analgesic drugs in newborns admitted to NICUs or PICUs in different countries in Europe. This study is conducted as part of the NeoOpiod study. The main objective of this study is to determine the current clinical practices regarding the use of sedative and analgesic drugs in newborns in intensive units in different countries in Europe. The principal criteria are: the frequency of ventilated neonates receiving sedation and analgesia, the medications used for sedation and analgesia in ventilated neonates, the length of use of medications administered for sedation and analgesia in ventilated neonates and similarities and differences in sedation and analgesia practices among European countries. The secondary objectives are: a) to determine the proportion of neonatal units that have developed and implemented local written guidelines to provide continuous sedation and analgesia in ventilated newborn infants as well as to prevent and treat procedural pain, b) to document the published guidelines for neonatal analgesia and sedation in different European countries and develop consensus for common European standards that can be applied in all medical settings, c) to determine the frequency of use of pain assessment tools in ventilated newborn infants and evaluate their impact on pain management practices and d) to determine practices to assess and prevent withdrawal syndromes. The EUROPAIN STUDY is observational and therefore it will not interfere with routine practices of participating units. No changes in diagnostic, therapeutic or any managing strategy of patients are imposed by the participation in this study. This epidemiological study will only collect data on clinical practices in each unit. It will include all neonates up to a corrected age of 44 weeks post conception. The maximum duration of data collection for every included infant is 28 days. Data collection will stop before 28 days if the infant leaves the unit (discharge, death, transfer to another hospital). Data will be entered on a secure web-based questionnaire.

NCT ID: NCT01648777 Completed - Pneumonia Clinical Trials

Catheter Outcomes With Sternotomy Cardiac Operated

STERNOCAT
Start date: March 2012
Phase: Phase 3
Study type: Interventional

Pneumonia occurs frequently in patients undergoing cardiac surgery and allows to increase their mortality. While chest physical therapy plays a crucial role to prevent postoperative pneumoniae, painful mobilization of the sternum after sternotomy limits chest physical therapy. The continuous local anesthetic infusion by multiperforated catheter decreases sternum pain. Because of this optimal pain management, early chest physical therapy could be more efficient and could contribute to decrease the rate of pneumonia. The aim of this study is to test if management of sternotomy pain using continuous local anesthetic infusion by multiperforated catheter may contribute to decrease the rate of perioperative pneumonia.

NCT ID: NCT01595867 Completed - Chronic Pain Clinical Trials

Abuse Potential Assessment of Intranasally Administered EMBEDA Compared To Morphine Sulfate Controlled Release And Placebo

Start date: August 2010
Phase: Phase 1
Study type: Interventional

This was a single-dose, randomized, double-blind, placebo-controlled, 3 way crossover study designed to evaluate the relative abuse potential of crushed EMBEDA® compared to morphine sulfate CR tablets and placebo in healthy male and female, non-dependent, recreational opioid users. An appropriate dose of morphine sulfate CR (i.e., 30 mg, 60 or 90 mg) was to be selected during Part A of the study (Dose Selection Phase). Each subject participated in the study for up to (approximately) 16 weeks and was confined in the clinic for a total of up to 12 nights.

NCT ID: NCT01582477 Completed - Analgesia Clinical Trials

TAP-patients With Robotic Assisted Lap Prostatectomy

TAP
Start date: March 2012
Phase: Phase 4
Study type: Interventional

The purpose of the study is to assess the safety and efficacy of EXPAREL when administered via infiltration into the transversus abdominis plane (TAP) to prolonged postsurgical analgesia in men undergoing robot-assisted laparoscopic prostatectomy.

NCT ID: NCT01571362 Completed - Chronic Pain Clinical Trials

A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain

Start date: June 2012
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to determine the analgesic efficacy and safety of ALO-02 extended-release capsules, when compared to placebo, in subjects with moderate to severe chronic low back pain.

NCT ID: NCT01568749 Completed - Analgesia Clinical Trials

A Study Investigating the Pharmacokinetic Profiles of Four Extended Release Paracetamol Formulations

Start date: December 2008
Phase: Phase 1
Study type: Interventional

A study investigating the pharmacokinetic profiles of four extended release paracetamol formulations

NCT ID: NCT01530542 Completed - Chronic Pain Clinical Trials

A Clinical Study To Characterize The Pharmacokinetics And The Effects Of Food On Oxycodone In Healthy Volunteers

Start date: July 2010
Phase: Phase 1
Study type: Interventional

This is an open-label (both the physician and healthy volunteer know which medication will be administered), single-dose, 5-dosing period study to characterize the pharmacokinetics (process by which oxycodone is absorbed, distributed, metabolized, and eliminated by the body) and the effects of food on the pharmacokinetics of oxycodone. The study will take place over approximately two and a half months and will consist of three phases: a screening visit to determine eligibility for the study, a 5-dosing period treatment phase, and an end-of-study visit.

NCT ID: NCT01346813 Completed - Pain Clinical Trials

Epidemiology of Painful Procedures in Neonates

EPIPPAIN
Start date: May 2011
Phase: N/A
Study type: Observational

Sick or premature neonates are exposed to frequent painful and stressful procedures during their stay in neonatal intensive care units. Although neonates do feel pain and may have long term effects induced by painful experiences, prevention and treatment of neonatal pain is far from optimal in many units. An epidemiological study (EPIPPAIN) conducted in neonatal and pediatric intensive care units in France in 2005 showed that painful procedures were extremely frequent and that analgesics treatments varied a lot among units. Since many guidelines have been issued by international scientific societies to manage neonatal pain, one may expect that the prevention and treatment of neonatal pain has improved over the last 6 years. Although awake endotracheal intubations are extremely difficult or impossible in older children or adults, such intubations are still frequently performed without sedation/analgesia in neonates. Recent studies have shown that premedications facilitate intubation conditions and greatly improve neonates tolerance of the procedure. Studies aimed at assessing the risks and benefits of different sedations/analgesia strategies are urgently needed in neonates. We also need a tool to assess at the same time the technical conditions of intubations and the tolerance of the neonate to the procedure so that data from different studies can be compared. The objectives of the present study are: 1. To describe the incidence of painful and stressful procedures performed in the neonate in intensive care units as well as in neonates transported by the medical emergency system (SMUR) of the Ile-de-France region 6 years after the first EPPIPAIN study conducted in the same region and same type of population in order to assess the evolution of practices. The description of painful and stressful procedures will be completed with a real-time around-the-clock assessment of the pain induced by procedures using a validated behavioral pain scale. 2. To link this study with The Epipage study 2 in order to look for associations between the number of painful and stressful procedures and/or analgesic treatments of the neonatal period and the neurological outcome of children that will be followed in the Epipage cohort. The Epipage study is a separate study that will follow for 13 years a cohort of premature neonates recruited in 2011. 3. To describe the incidence of painful or stressful procedures and analgesic treatments in neonates transported by the pediatric emergency system (SMUR) of the Ile-de-France region in France. 4. To obtain initial validity of a tool permitting to assess intubations in neonates. An observational detailed description of endotracheal intubations conditions will be conducted in neonates transported and intubated by SMUR and in neonates intubated in intensive care units 5. To describe continuous sedation and analgesia practices in ventilated neonates in intensive care units. For these neonates, data from medical records will be recovered up to 2 months of admission in intensive care units 6. To describe the frequency of heel sticks for glycemia measurement and blood gazes practices among centers. Relate heel stick practices to the normality or abnormality of glycemia results

NCT ID: NCT01299584 Completed - Analgesia Clinical Trials

ULTIVA Post Marketing Surveillance

Start date: September 2005
Phase: N/A
Study type: Observational

This study is a post-marketing surveillance to monitor safety and efficacy of remifentanil during various surgeries and identify SAEs, adverse drug reactions, and unexpected AEs not described as precautions or warnings and to identify prognostic factors that have an effect on the AEs and to assess effectiveness of remifentanil in real clinical practices after marketing. The subjects are patients prescribed for remifentanil by the investigators at the sites based on prescription information in normal clinical practices.