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10 Study Matches

Serratus Anterior Plane Block in Patients Undergoing Mastectomy

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studyfinder@utsouthwestern.edu
Anthony Machi
159003
All
18 Years and over
Phase 4
This study is NOT accepting healthy volunteers
NCT03154658
STU 122016-011
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Inclusion Criteria:
1. Adult patients 18 years or older 2. Individuals undergoing either a mastectomy or mastectomy with tissue expander for which the anesthetic plan includes a serratus anterior plane block.
Exclusion Criteria:
1. Any known sensory deficit of the anterolateral chest wall. 2. Any local disorder of the skin or otherwise where blockade is to be performed which would prevent safe performance of the block 3. Pregnancy 4. American Society of Anesthesiology classification greater than 3 5. Allergy to amide local anesthetic medications 6. Chronic pain conditions 7. Preoperative opioid use greater than 20 oral morphine equivalents per day 8. Any coagulation abnormality which would be a contraindication for block placement 9. Preoperative chronic renal dysfunction requiring renal replacement therapy or a serum creatinine greater than 1.4 mg/dL 10. Body mass index >50 11. Incarceration 12. Inability to understand study procedures including inability to understand the English language 13. Inability to provide adequate informed consent 14. Refusal to participate in the study
Drug: Ropivacaine 0.35%
Pain, Post-operative
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Epidural and Intravenous Patient-Controlled Analgesia Following Lumbar Spinal Fusion Surgery

Postoperative analgesia following spine surgery is difficult to manage. Current treatment modalities rely heavily on opioid analgesics with all of the inherent limitations and side effects. While current best practice focuses on a 'multimodal approach' (i.e. using multiple different drugs and techniques to control pain after surgery), there is no consensus regarding which components of this multimodal therapy provide optimal analgesia. This prospective randomized study will enroll patients undergoing elective Lumbar Spinal Fusion Surgery at Zale Lipshy University Hospital. The primary objective is to determine the comparative efficacy of epidural analgesia, as compared with intravenous (IV) patient-controlled analgesia (PCA), on post-operative analgesia.
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Enas Kandil
74036
All
18 Years to 80 Years old
Phase 4
This study is NOT accepting healthy volunteers
NCT03115151
STU 092016-061
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Inclusion Criteria:

• Adult subjects aged 18 years or older
• Scheduled for elective posterior lumbar spinal fusion surgery between 1 and 3 levels
Exclusion Criteria:

• Baseline cognitive deficits sufficient to make objective pain self-assessments unreliable in the estimation of the Study Investigators.
• Immunocompromised subject
• Coagulopathy
• Severe liver and renal dysfunction
• Preoperative neurological deficits
• The dura damage during surgery
• Inability to follow directions or comprehend the English language.
• Females who are pregnant as determined by positive pregnancy test on or before the day of surgery.
• Prisoners.
• Patient refusal to provide informed consent.
• Allergy to amide local anesthetics (lidocaine, bupivacaine, ropivacaine) or opioid (fentanyl).
Drug: Bupivacaine, Drug: Hydromorphone, Drug: Fentanyl
Pain
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Standard of Care Therapy With or Without Stereotactic Radiosurgery and/or Surgery in Treating Patients With Limited Metastatic Breast Cancer

Call 1-888-980-6050
canceranswerline@utsouthwestern.edu
Assal Rahimi
115315
Female
18 Years and over
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
NCT02364557
STU 052016-046
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Inclusion Criteria:

• Pathologically confirmed metastatic breast cancer
• Known estrogen, progesterone, and HER2 status of either primary tumor or metastasis
• ≤ 4 metastases seen on standard imaging within 60 days prior to registration when all metastatic disease is located within the following sites:
• peripheral lung
• osseous (bone)
• spine
• central lung
• abdominal-pelvic(lymph node/adrenal gland)
• liver
• mediastinal/cervical lymph node
• All known disease amenable to metastasis-directed therapy with either SBRT or resection
• NOTE: Symptomatic bone metastasis are allowed if ablative therapy can be delivered
• NOTE: Sites for possible surgical excision include lung, liver, adrenal gland, bone, small intestine, large intestine, ovary, and amenable nodal disease sites
• NOTE: Surgical stabilization is allowed for a metastasis if it is followed by conventionally fractionated external beam radiotherapy
• Maximum diameter of individual metastasis in any dimension ≤ 5 cm
• There are no restrictions on distance between the metastases
• Patients must be registered within 365 days of the initial metastatic breast cancer diagnosis. First-line standard systemic therapy (chemotherapy, anti-endocrine therapy, anti-HER2 or other standard targeted therapy) for metastatic breast cancer must be given or planned to be given. If given before study entry, it cannot have exceeded a duration of 12 months at the time of registration. (Note: Sequencing of ablative therapy (surgery or SBRT) relative to systemic therapy, for patients randomized to Arm 2, is at the discretion of the treating physician.)
• The primary tumor site must be controlled prior to registration
• For those who present with synchronous primary and oligometastatic disease: Primary must be controlled prior to registration. The definition of control is definitive surgery by excision or mastectomy (+/- radiotherapy) per institution preference
• For those who present with local recurrence and oligometastatic disease, local recurrence must be controlled prior to registration The definition of control is definitive surgery by excision or mastectomy (+/- radiotherapy) per institution preference
• Appropriate stage for study entry based on the following diagnostic workup:
• History/physical examination within 60 days prior to registration
• Clinical grade computed tomography (CT) scans of the chest, abdomen, and pelvis with radionuclide bone scan OR whole body positron emission tomography (PET)/CT within 60 days prior to study registration
• Zubrod performance status ≤ 2 within 60 days prior to registration
• Absolute neutrophil count (ANC) ≥ 500 cells/mm^3
• Platelets ≥ 50,000 cells/mm^3
• Hemoglobin ≥ 8.0 g/dl (note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] ≥ 8.0 g/dl is acceptable)
• For females of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to study registration
Exclusion Criteria:

• Pathologic evidence of local/regional breast tumor recurrence at the time of registration
• Co-existing or prior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 3 years; previous RT dose, date, fraction size, must be reported
• Metastases with indistinct borders making targeting not feasible
• NOTE: A potential issue with bone metastases is that they often are not discrete. Since many patients on this protocol will have bone metastases, this will be an important issue. Theoretically, Houndsfield units might provide an appropriate measure; however, a sclerotic lesion against dense cortical bone will not have a sharp demarcation based on Houndsfield units (HU). Therefore, we acknowledge that such determinations will pose a challenge and thus the physician's judgment will be required
• Prior palliative radiation treatment for metastatic disease (including radiopharmaceuticals)
• Metastases located within 3 cm of the previously irradiated structures:
• Spinal cord previously irradiated to > 40 Gy (delivered in ≤ 3 Gy/fraction)
• Brachial plexus previously irradiated to > 50 Gy (delivered in ≤ 3 Gy/fraction)
• Small intestine, large intestine, or stomach previously irradiated to > 45 Gy (delivered in ≤ 3 Gy/fraction)
• Brainstem previously irradiated to > 50 Gy (delivered in ≤ 3 Gy/fraction)
• Whole lung previously irradiated with prior V20Gy > 30% (delivered in ≤ 3 Gy/fraction)
• Primary tumor irradiated with SBRT
• Metastasis irradiated with SBRT
• Brain metastases
• Exudative, bloody, or cytological proven malignant effusions
• Severe, active co-morbidity defined as follows:
• Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
• Transmural myocardial infarction within the last 6 months
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
• Pregnancy; lactating females must cease expression of milk prior to signing consent to be eligible
• Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD)4 count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol
Radiation: Stereotactic Radiosurgery, Procedure: Therapeutic Conventional Surgery, Other: Laboratory Biomarker Analysis
Fatigue, Stage IV Breast Cancer, Pain, Nausea and Vomiting, Dyspnea
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ANI Versus Standard Care in Surgical Patients Receiving Balanced Sevoflurane-Fentanyl Anesthesia

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studyfinder@utsouthwestern.edu
Tiffany Moon
66760
All
18 Years to 75 Years old
N/A
This study is also accepting healthy volunteers
NCT03684590
STU-2018-0096
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Inclusion Criteria:

• 18-75 years old
• ASA 1-2
• BMI 19-35 kg/m2
• Patients undergoing surgery with general anesthesia with sevoflurane- fentanyl
• Planned abdominal or spinal surgery lasting 1-3 hours
• Willing and able to consent in English or Spanish
• No current history of advanced pulmonary or cardiovascular disease
Exclusion Criteria:

• Age less than 18 or older than 75
• Patient does not speak English or Spanish
• Patient refusal
• Monitored anesthesia care (MAC) or regional anesthesia planned
• Pregnant or nursing women
• "Stat" (emergent) cases
• ECG rhythm other than regular sinus rhythm
• Implanted pacemakers
• On antimuscarinic agents, alpha 2 agonists, antiarrhythmics, or beta blockers
• Presence of pacemaker
• Autonomic nervous system disorder
• Use of chronic opioids
Device: ANI-guided opioid administration, Other: Standard opioid administration
Acute Pain
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Clinical Study to Evaluate the Effectiveness, Safety, and Tolerability of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects

The purpose of the study is to evaluate the efficacy, tolerability, safety and pharmacokinetics of Oxymorphone HCl as an analgesic for acute moderate to severe post-operative pain in pediatric subjects.
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studyfinder@utsouthwestern.edu
Peter Szmuk
80418
All
up to 2 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT02687451
STU 102015-024
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Inclusion Criteria:
1. Is male or female <2 years of age at the time of surgery. 2. Must weigh at least 3 kg. 3. Is scheduled to have a surgical procedure for which opioid analgesia will be needed to manage postoperative pain for at least 18 hours following intraoperative and/or postoperative IV analgesia. 4. Is generally healthy as documented by medical history; physical examination (including, but not limited to, the cardiovascular, gastrointestinal, respiratory, and central nervous systems); vital sign assessments; 12-lead electrocardiograms (EKGs); clinical laboratory assessments; and general observations. Any abnormalities or deviations from the acceptable range that might be considered clinically relevant by the study physician or investigator will be evaluated on a case-by-case basis, agreed upon by the Principal Investigator (or sub-investigator), and documented in study files before enrolling the subject in the study. 5. The subject's parent or guardian has been informed of the nature of the study and has provided written informed consent. Postoperative: 6. Is anticipated to require an analgesic regimen using a short-acting opioid (non-oxycodone and non-oxymorphone) analgesic after surgery (according to standard of care (SOC) as defined in the protocol). 7. Is an inpatient expected to be hospitalized for 24 hours after dosing with study drug. 8. Has an indwelling access catheter for blood sampling. 9. Has demonstrated the ability to tolerate clear fluids following surgery according to the SOC at each institution. All infants and children should be able to demonstrate strong suck and swallow reflexes and neurologic alertness and stability sufficient to handle oral secretions. The ability to tolerate small amounts (1 to 2 oz.) of clear liquids without emesis (over 30 to 60 minutes) would support readiness for study participation and oral intake once the physician has ordered the diet advanced to clear liquids and the subject has ingested fluids by mouth without nausea or vomiting.
Exclusion Criteria:
1. Has the presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or nervous system(s) or psychiatric disease that would contraindicate participation, as determined by the Investigator. 2. Has any clinical laboratory test result outside the accepted range that has been confirmed upon re-examination and deemed to be clinically significant. 3. Has a clinically significant illness or condition any time before dosing with study drug that would contraindicate participation, as determined by the Investigator. 4. Has a life expectancy <8 weeks. 5. For age groups A and B: Has a malabsorption, gastroenterologic, or abdominal condition that would interfere with the absorption of study drug. 6. Has evidence of increased intracranial pressure. 7. Has a respiratory condition requiring intubation or resulting in active bronchiolitis, asthma, stridor, or difficulty breathing due to congestion and increased nasal secretions, including oxygen (O2) saturation ≤92%. 8. Has a history of seizures. 9. Subject (and/or mother if subject is nursing) has used medications with actions characteristic of monoamine oxidase inhibitors (MAOIs) within 14 days before the start of the study drug is prohibited. Standard daily pediatric multivitamins may be taken until enrollment into the study but will be restricted during the study. 10. Subject (and/or mother if subject is nursing) has received preoperative opioids for more than 72 consecutive hours. 11. Subject (and/or mother if subject is nursing) has received oxycodone or oxymorphone within 48 hours prior to screening. 12. Subject (and/or mother if subject is nursing) has ingested caffeine- or xanthine-containing products (eg, theophylline) within 48 hours before dosing. These products are also prohibited during periods when blood samples are collected. 13. Has a history of relevant drug allergies, food allergies, or both (ie, allergy to oxymorphone or other opioid analgesics) that could interfere with the study. 14. Parent or legal guardian is unable to provide consent for any reason (eg, mental or physical disabilities, language barriers, or is unavailable). 15. Subject (and/or mother if subject is nursing) has participated in a clinical study of an unapproved drug within the previous 30 days. 16. Is not suitable for entry into the study in the opinion of the Investigator.
Drug: Oxymorphone HCl, Drug: Placebo
Post-operative Pain, Acute Pain
Surgical Pain, Acute Post-Surgical Pain
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A Study to Compare the Long-term Outcomes After Two Different Anaesthetics (TREX)

There is considerable evidence that most general anaesthetics modulate brain development in animal studies. The impact is greater with longer durations of exposure and in younger animals. There is great controversy over whether or not these animal data are relevant to human clinical scenarios. The changes seen in preclinical studies are greatest with GABA agonists and NMDA antagonists such as volatile anaesthetics (eg sevoflurane), propofol, midazolam, ketamine, and nitrous oxide. There is less evidence for an effect with opioid (such as remifentanil) or with alpha 2 agonists (such as dexmedetomidine). Some, but not all, human cohort studies show an association between exposure to anaesthesia in infancy or early childhood and later changes in cognitive tests, school performance or risk of developing neurodevelopmental disorders. The evidence is weak due to possible confounding. A recent well designed cohort study (the PANDA study) comparing young children that had hernia repair to their siblings found no evidence for a difference in a range of detailed neuropsychological tests. In that study most children were exposed to up to two hours of anaesthesia. The only trial (the GAS trial) has compared children having hernia repair under regional or general anesthesia and has found no evidence for a difference in neurodevelopment when tested at two years of age. The GAS and PANDA studies confirm the animal data that short exposure is unlikely to cause any neurodevelopmental impact. The impact of longer exposures is still unknown. In humans the strongest evidence for an association between surgery and poor neurodevelopmental outcome is in infants having major surgery. However, this is also the group where confounding is most likely. The aim of our study is to see if a new combination of anaesthetic drugs results in a better long-term developmental outcome than the current standard of care for children having surgery lasting at least 2..5 hours. Children will be randomised to receive either a low dose sevoflurane/remifentanil/dexmedetomidine or standard dose sevoflurane anaesthetic. They will receive a neurodevelopmental assessment at 3 years of age to assess global cognitive function.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Peter Szmuk
80418
All
up to 2 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT03089905
STU 052017-065
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Inclusion Criteria:

• Younger than 2 years (chronological age)
• Scheduled for anaesthesia that is expected to last at least 2 hours (and/or total operating room time is scheduled to be at least 2.5 hours)
• Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.
Exclusion Criteria:

• Known neurologic, chromosomal or congenital anomaly which is likely to be associated with poor neurobehavioural outcome
• Existing diagnosis of behavioural or neurodevelopmental disability
• Prematurity (defined as < 36 weeks gestational age at birth)
• Birth weight less than 2 kg.
• Congenital cardiac disease requiring surgery
• Intracranial neurosurgery and intracranial craniofacial surgery (isolated cleft lip is not an exclusion)
• Previous cumulative exposure to general anaesthesia exceeding 2 hours
• Planned future cumulative exposure to anaesthesia exceeding 2 hours before the age of 3 years.
• Any specific contra-indication to any aspect of the protocol
• Previous adverse reaction to any anaesthetic
• Circumstances likely to make long term follow-up impossible
• Living in a household where the primary language spoken at home is not a language in which we can administer the Wechsler Preschool and Primary School Intelligence Scale
• Planned postoperative sedation with any agent except opioids (e.g. benzodiazepines, dexmedetomidine, ketamine, barbiturates, propofol, clonidine, chloral hydrate, and other non-opioid sedatives). For example if such sedation is planned for post-operative ventilation
Drug: Sevoflurane, Drug: Remifentanil, Drug: Dexmedetomidine
Neurotoxicity, Anesthesia, Child Development
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Study of Oral Morphine Sulfate Administration in Pediatric Subjects

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Peter Szmuk
80418
All
2 Years to 17 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT03429400
STU 042018-097
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Inclusion Criteria:
1. Has a parent or guardian providing written parental permission/informed consent, with subject assent (if required by local IRB). 2. Has an age-appropriate pain score of ≥4 prior to receiving first dose of study drug. 3. Is a child 2 years old through 17 years old, inclusive (at the time of informed consent signing). 4. Weighs at least 10 kg. 5. Has a routine pediatric procedure that is expected to require inpatient hospitalization postoperatively. 6. Must be an inpatient for the study treatment period. 7. Is expected by the investigator to have moderate to severe postoperative pain requiring the use of oral opioids for treatment. 8. Has the ability to read and understand the study procedures and has the ability to communicate meaningfully with the study investigator and staff (if the subject is of preverbal age or cannot read or communicate meaningfully, then the subject's parent or guardian must meet this criterion). 9. Is able to tolerate oral medications within 48 hours of surgery. 10. If female subject is of childbearing potential, she must have a negative urine pregnancy test result on the day of surgery prior to surgery. In this population, female of childbearing potential is defined by the onset of menarche, ie, menstruation, whether at irregular or regular intervals (periods). 11. Female subjects of childbearing potential and male subjects with partners capable of reproduction must agree to use an effective contraceptive method as follows from the time of Screening through 30 days after the last dose of study drug:
• A highly effective method of contraception, including hormonal contraceptives (eg, combined oral contraceptives, patch, vaginal ring, injectables, and implants), intrauterine device or intrauterine system OR
• An effective double-barrier contraceptive method (2 of the following: male condom, female condom, cervical cap, diaphragm, or contraceptive sponge) OR
• Abstinence 12. Must have vascular access to facilitate blood draws.
Exclusion Criteria:
1. Has significant medical disease(s), laboratory abnormalities, or conditions(s) that in the investigator's judgment could compromise the subject's welfare, ability to communicate with study staff, complete study activities, or would otherwise contraindicate study participation. There is no minimum value for SpO2 for inclusion in the study; this should be based on the investigator's judgment. 2. Has used opioids chronically (eg, codeine, morphine, oxycodone, or hydromorphone), for >7 calendar days within the previous 30 days prior to surgery. 3. Has received codeine, hydrocodone, morphine or oxycodone in any form in the previous 7 calendar days prior to surgery. 4. Is undergoing procedure for treatment of acute burns. 5. Has known hypersensitivity or contraindication to receiving oral opioid(s). 6. Has a current active enteral malabsorption disorder. 7. Has impaired liver function (eg, alanine aminotransferase [ALT] ≥3 times the upper limit of normal [ULN], or total bilirubin ≥2 times ULN [except patients with evidence of Gilbert's syndrome]), known active hepatic disease (eg, hepatitis), evidence of clinically significant chronic liver disease or other condition affecting the liver (eg, chronic hepatitis) that may suggest the potential for an increased susceptibility to hepatic toxicity with oral morphine exposure. Subjects with no previous history of liver function impairment may be enrolled prior to receipt of screening laboratory testing results. 8. Has significantly impaired renal function or disease, as evidenced by an estimated glomerular filtration rate (ie, from creatinine levels using the Schwartz formula) calculated to be less than one-third of normal for the applicable age of this study population. Subjects with no previous history of kidney function impairment may be enrolled prior to receipt of screening laboratory testing results. 9. Has a history of substance abuse or there is evidence of current substance abuse, in the investigator's opinion. 10. Has received epidural or regional anesthesia within 12 hours prior to the first dose of study drug. 11. Has participated in an interventional clinical study (investigational or marketed product) within 30 days before screening, or plans to participate in another clinical trial in the next 30 days.
Drug: Morphine Sulfate
Pain, Postoperative
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Cocaine Use and Outcomes of General Anesthesia

In this prospective study, investigators plan to evaluate the outcome of general anesthesia in the context of patients with a positive cocaine urine test. Patients with a positive urine cocaine test who do not appear acutely toxic and have normal vital signs may not have an increased rate of perioperative complications during elective surgery compared to similar patients with negative urine cocaine screening tests. Patients who are chronic cocaine users may have a higher anesthetic requirement.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Tiffany Moon
66760
All
18 Years to 70 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02692534
STU 062015-066
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Inclusion Criteria:

• 18-70 years old
• ASA physical status classification 1 to 3
• Personal history of cocaine abuse in the last year
• Scheduled for a non-emergent operation that requires general anesthesia
• Vital signs within generally accepted ranges for normal [HR 60-100, RR 12-20, SpO2 > 96% on room air, BP 90-140/60-90 unless a diagnosis of hypertension is present, T 36-38 degrees)
• Willing and able to consent in English or with use of appropriate language translator
Exclusion Criteria:

• Age less than 18 or older than 70
• Unable to give informed consent for participation in the study
• Patient refusal
• Monitored anesthesia care (MAC) or regional anesthesia planned
• Pregnant or nursing women
• Emergent surgery (designated with an E on the end of the ASA status)
• Patient on other illicit drugs except marijuana (e.g., amphetamine)
• Acute cocaine intoxication based on clinical symptomatology (hypertension, tachycardia, agitation, delirium, hyperthermia)
• History of cardiac disease including coronary artery disease (CAD) and cardiac dysrhythmia
• History of stroke
• History of seizure disorder
• On dialysis
Other: Urine cocaine negative, Other: Urine cocaine positive
Anesthesia
Anesthesia, Cocaine Use
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Evaluate The Pharmacokinetics and Safety Of Oxycodone Oral Solution In Pediatric and Adolescent Subjects

The objective of this study is to characterize the pharmacokinetics and to evaluate the safety of single and multiple doses of Oxycodone Oral Solution in pediatric and adolescent subjects for postoperative pain.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Peter Szmuk
80418
All
up to 17 Years old
Phase 4
This study is NOT accepting healthy volunteers
NCT01959204
STU 112012-016
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Inclusion Criteria:
1. Is male or female <17 years of age at the time of dosing. 2. Subject 2 to <17 years of age, be in at least the 25% for weight according to the Center for Disease Control pediatric growth charts and weighs at least 28 lb at the time of dosing with study drug. 3. Is generally healthy as documented by medical history (except for the condition for which the procedure is being performed); physical examination (including, but not limited to, the cardiovascular, gastrointestinal, respiratory, and central nervous systems); vital sign assessments; 12-lead electrocardiograms; clinical laboratory assessments; and general observations. Has a negative serum pregnancy test at Screening and predose check in for females of childbearing potential. 4. Is an outpatient for a surgical procedure and is expected to remain hospitalized for at least 24 hours after dosing with study drug. 5. Is anticipated to have postsurgical pain requiring a parenteral analgesic regimen using a short-acting opioid analgesic and is anticipated to be switched to an oral opioid for at least 1 dose (according to institution standard of care). 6. Has an indwelling access catheter for blood sampling. 7. Agrees to comply with all protocol requirements. If not old enough, the legally responsible parent(s) or legal guardian(s) must agree to comply with all protocol requirements. 8. Has been informed of the nature of the study and informed consent and assent (as appropriate) have been obtained from the legally responsible parent(s) or legal guardian(s) and the subject, respectively, in accordance with institutional review board requirements.
Exclusion Criteria:
1. Has the presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (except for the condition for which the procedure is being performed) as determined by the clinical investigator. 2. Has any clinical laboratory test result outside the normal range. 3. Has a positive test result for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus antibody. 4. Had a clinically significant illness, except for the condition for which the procedure is being performed, in the 28 days before dosing with study drug as determined by the clinical investigator. 5. Is a lactating or breastfeeding female. 6. Uses any medication known to be an inhibitor or inducer of CYP3A4 within 14 days (for inhibitors such as the azole-antifungal agents voriconazole and ketoconazole, macrolide antibiotics such as erythromycin, and protease inhibitors such as ritonavir) or 28 days (for inducers such as rifampin, carbamazepine, and phenytoin) of dosing with study drug. Use of all other prescription medications, except required pre-op medications and birth control, is prohibited within 3 days of dosing with study drug. Use of any over-the-counter medications (including herbal or dietary supplements and therapeutic doses of vitamins), except for required pre-op medications, is prohibited within 24 hours of dosing with study drug, with the exception of topical spermicide. Use of St. John's wort is prohibited from 28 days before dosing until 14 days after dosing. Standard daily dose multivitamins (nontherapeutic doses) may be taken until enrollment into the study but will be restricted during the study. 7. Consumes alcohol-, caffeine-, or xanthine-containing products within 48 hours before dosing and during periods when blood samples are collected. 8. Consumes grapefruit, grapefruit products, Seville oranges, or pomelo-containing products within 14 days of dosing. Fruit juices, with the exception of apple and grape, will be prohibited during the study. 9. Is a smoker or has used nicotine or nicotine-containing products within 30 days of dosing. 10. Has a history of alcohol or drug addiction or abuse within the last year. 11. Subject 2 to <17 years of age, has a positive urine test result for drugs of abuse (amphetamines, barbiturates, cannabinoids, cocaine metabolites, opiates, phencyclidine, and benzodiazepines) or alcohol at Screening (not required for subjects less than 2 years of age). 12. Donated blood within 28 days or plasma within 14 days of dosing or plans to donate them within 4 weeks after completing the study. 13. Has a history of relevant drug allergies, food allergies, or both (i.e., allergy to oxycodone, allergy to related drugs, or any significant food allergy that could interfere with the study). 14. Is intolerant to direct venipuncture. 15. Received an investigational drug within 28 days of dosing. 16. Has taken oxycodone or oxymorphone within the 48 hours before anticipated dosing with study drug. 17. Is not suitable for entry into the study in the opinion of the investigator.
Drug: Oxycodone
Pain
pharmacokinetics, safety
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The Videolaryngoscopy in Small Infants (VISI)

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Patrick Olomu
103420
All
up to 12 Months old
N/A
This study is NOT accepting healthy volunteers
NCT03396432
STU 052018-020
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Inclusion Criteria 1. Males or females age 0 to <12 months. 2. Scheduled for non-cardiac surgery or procedure lasting longer than 30 minutes under general anesthesia where oral endotracheal intubation will be performed by an anesthesiology clinician. 3. Subject/Parental/guardian permission (informed consent). Inclusion for clinician participants: 1. Pediatric anesthesia attending, pediatric anesthesia fellows, and anesthesia resident 2. Complete the manikin training and watching study training video 3. Willing to provide professional training and device experiences 4. Scheduled to perform intubation on a consented VISI patient Exclusion Criteria 1. History of difficult intubation 2. History with abnormal airway 3. Predictive of difficult intubation upon physical examination 4. Parents/guardians who, in the opinion of the investigator, may be unable to understand or give informed consent Exclusion for clinician participants: Anesthesia attending who does not have VL experiences in infant
Device: Video Laryngoscopy for ET placement, Device: Direct Laryngoscopy for ET Placement
Surgery, Anesthesia, Endotracheal
laryngoscope, intubation, first attempt success, oxygen saturation, airway management, Videolaryngoscopy, Direct laryngoscopy
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