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Pain clinical trials

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NCT ID: NCT01780818 Completed - Pain Clinical Trials

A Comparison of Air Insufflation, Water Immersion and Water Exchange Colonoscopy in CRC Screening

Start date: March 2013
Phase: N/A
Study type: Interventional

Water-aided method for colonoscopy can be broadly subdivided into two major categories. Water Immersion (WI), characterized by suction removal of the infused water predominantly during the withdrawal phase of colonoscopy, and Water Exchange (WE), characterized by suction removal of infused water predominantly during the insertion phase of colonoscopy. Several studies showed that WE significantly reduces pain compared to WI and colonoscopy with traditional air insufflation (AI), increases the number of unsedated procedures and adenoma detection rate (ADR), in particular proximal ADR. This randomized controlled trial will be a direct comparison of Air Insufflation, Water Immersion and Water Exchange to test the hypothesis that WAC (particularly WE) would significantly decrease pain score during colonoscopy in average-risk screening patients. Several other secondary outcomes will also be analyzed.

NCT ID: NCT01780428 Completed - Pain Clinical Trials

Phase III Study of the Safety and Efficacy of Cl-108 in the Treatment of Moderate to Severe Pain

Start date: January 2013
Phase: Phase 3
Study type: Interventional

This is a double-blind, randomized, multiple-dose, placebo- and positive-controlled study of CL-108 (hydrocodone 7.5 mg/APAP 325 mg, promethazine 12.5 mg) in patients with moderate to severe pain following surgical removal of impacted third molar teeth. A positive control ( Norco, a commercial formulation of hydrocodone 7.5 mg/APAP 325 mg) was included to determine the anti-emetic effects of CL-108. The efficacy of CL-108 was also evaluated to placebo for the relief of pain.

NCT ID: NCT01780233 Completed - Pain Clinical Trials

Pharmacokinetic Study of Fentanyl 400 µg Sublingual Spray, Actiq® 400 µg Transmucosally, and Fentanyl Citrate Injection 100 µg Intravenously (iv)

Start date: April 2007
Phase: Phase 1
Study type: Interventional

The objective of this study was to compare the rate of absorption and bioavailability of fentanyl 400 µg sublingual spray, Actiq® 400 µg transmucosally, and fentanyl citrate injection 100 µg intravenously.

NCT ID: NCT01777087 Completed - Pain Clinical Trials

Functional Brain Imaging of Pain Phenotype and Genotype

Start date: January 2013
Phase: N/A
Study type: Interventional

This study has two purposes: first, to locate and identify the "brain activation" (the areas of the brain) which respond to pain; and second, to look at how brain activation is influenced by a person's genetics (the traits they inherited from their parents). A Magnetic Resonance Imaging (MRI) scanner will be used to gather pictures of the brain (similar to an x-ray, but based on different scientific principles) that will be used to determine which areas are active. The hypothesis is that the variation in brain activity between people can be partially explained by genetic differences. This study consists of an two pain tasks applied during a one time visit to the MRI suite. There are no followup visits.

NCT ID: NCT01775371 Completed - Pain Clinical Trials

Effectiveness and Feasibility of Patient Controlled Analgesia in the ED

Start date: April 2013
Phase: N/A
Study type: Interventional

Background: Inadequate pain management is common in the Emergency Department (ED). Optimal treatment of pain necessitates titration to effective dose due to the large inter-individual variability in opioid requirement. However nurse administered titration is difficult to provide in this setting due to high patient to nurse and physician ratios and multiple urgent competing patient demands. Patient controlled analgesia (PCA) lets ED patients actively participate in pain management by allowing self-titration to their desired level of pain relief. A tightly controlled randomized clinical trial (RCT) funded by the National Institute of Nursing Research (NINR) recently completed by the investigators group provides promising preliminary support for the efficacy and safety of PCA for patients with abdominal pain at a single ED with a dedicated research nurse and standard loading dose given to all patients. Objective: The overall objective is to provide optimal pain management in the ED. Specific aims: 1)To compare the effectiveness and safety of PCA and non-PCA opioid analgesia when nurses involved in clinical care deliver the intervention to a broad group of ED patients with acute pain at multiple clinical centers. The primary hypothesis is that there will be a greater decline in pain over time and similar safety in patients randomized to receive PCA compared to patients receiving standard opioid analgesia. 2) To describe the feasibility of PCA in terms of patient and provider acceptance, resource utilization and cost associated with PCA. Innovation: PCA represents a novel shift from the current provider-driven model of ED pain management to one in which the patient is an active participant. Few prior studies have evaluated ED PCA and no systematic evaluation of time and resources exists. Methodology: An RCT will be performed at 3 clinical centers. 750 patients with acute pain warranting IV opioid administration will be randomized to receive usual opioid analgesia determined by the provider or PCA (loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes). Pain intensity will be measured by a numerical rating scale (NRS) recorded every half hour up to 2 hours after initial opioid administration. Primary endpoints are rate of change in pain intensity from 30 minutes after initial administration of opioid to 2 hours as suggested by the results of the preliminary study and incidence of adverse events. PCA will also be compared to non-PCA opioid analgesia assessed at the end of the 2 hour study period by patient satisfaction with pain management; registered nurse (RN) assessment of time efficiency/ease of use and satisfaction with pain management; and physician satisfaction with pain management. Resource utilization and cost associated with implementation and use of PCA in the ED setting will be assessed by total Registered nurse (RN) time spent on pain management per patient; pharmacy preparation time per patient; material cost per patient and Registered Nurse and Physician training time necessary for PCA implementation. Significance: If PCA is demonstrated to be effective, safe, and associated with patient and provider acceptance and acceptable resource utilization, it has the potential to significantly improve ED pain management.

NCT ID: NCT01773005 Completed - Pain Clinical Trials

Caldolor Versus Caldolor Plus OFIRMEV in Total Knee or Hip Arthroplasty Surgeries

Start date: December 2012
Phase: Phase 4
Study type: Interventional

The objective of this study is to compare the effectiveness and of perioperative use of Caldolor alone and in combination with OFIRMEV in total knee or hip arthroplasty procedures.

NCT ID: NCT01771822 Completed - Pain Clinical Trials

Ibuprofen 5% Topical Gel CIPT

Start date: January 2013
Phase: Phase 1
Study type: Interventional

This study will determine the potential of Ibuprofen 5% Topical Gel and its vehicle gel to cause irritation after repeated topical application to the healthy skin of human subjects under controlled conditions.

NCT ID: NCT01770912 Completed - Pain Clinical Trials

Efficacy of Steroid Supplementation After TMJ Rinsing for Pain Management

Start date: March 2013
Phase: Phase 2
Study type: Interventional

The hypothesis to be tested is temporomandibular joint (TMJ) rinsing followed by steroid injection is more efficacious than a placebo injection based on standard pain and physical measures that are recorded before and after treatment. All procedures will be the same as if following normal TMJ arthrocentesis (rinsing) clinical care except that the patient will be randomly assigned to one of two groups: (1) TMJ rinsing followed by the injection of 1 cc (about ¼ of a teaspoon) of the same rinsing solution (this is the placebo) into the jaw joint; or (2) TMJ rinsing followed by the injection of 1 cc (about ¼ teaspoon) of a steroid (5 mg of triamcinolone hexacetonide) into the jaw joint. A pregnancy test (urine test) will be conducted on all women of child-bearing age to verify that the patient is not pregnant before the rinsing procedure. The patient will fill out a short questionnaire and have a short exam of the TMJ and jaw muscles at each appointment.

NCT ID: NCT01769677 Completed - Pain Clinical Trials

A Crossover Study to Assess the Bioequivalence of Hydrocodone Bitartrate Extended-Release Tablet

Start date: January 2013
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to assess the bioequivalence of two 45-mg hydrocodone bitartrate extended-release tablets and one 90-mg hydrocodone bitartrate extended-release tablet.

NCT ID: NCT01767922 Completed - Pain Clinical Trials

Multicentre, Double-blind Study Versus Placebo on Impact and Safety of Extramel® 140 IU on Perceived Stress, Physical and Intellectual Fatigue, Pain Perception if Present, and the Impact on the Quality of Life

Ex Stress II
Start date: September 2008
Phase: Phase 3
Study type: Interventional

Objectives of this Multicentre, double-blind study versus placebo were to evaluate impact and safety of the daily administration of Extramel® 140 IU SOD for 12 weeks on perceived stress, physical and intellectual fatigue, pain perception, if present, and the impact on the quality of life of 70 subjects included with 60 that can be evaluated.