| Trial | Phase | Enrollment | Study Type | Start Date | Status |
|---|
| Saline Injection - Assisted Anesthesia in Eyelid Surgery [NCT01239498] | Phase 4 | 60 participants (Anticipated) | Interventional | 2010-11-30 | Recruiting |
| Bupivacaine Versus Lidocaine Infiltration for Postoperative Pain in Thyroid Surgery: A Randomized Controlled Trial [NCT04427904] | Phase 2 | 210 participants (Anticipated) | Interventional | 2022-06-01 | Recruiting |
| ED50 and ED95 of Intrathecal Bupivacaine With or Without Epinephrine for Total Knee Replacement Arthroplasty [NCT01264575] | | 162 participants (Actual) | Interventional | 2009-12-31 | Completed |
| Combined Subconjunctival Atropine and Intracameral Epinephrine Injection for Pupil Dilation in Phacoemulsification Under Peribulbar Anesthesia. [NCT03638726] | Phase 4 | 40 participants (Anticipated) | Interventional | 2018-09-28 | Recruiting |
| Antecubital Versus Femoral Approach for Adrenal Venous Sampling: A Randomised Controlled Trial [NCT06029803] | | 154 participants (Anticipated) | Interventional | 2022-04-01 | Recruiting |
| Randomized Control Trial of Ultrasound-Guided Erector Spinae Block Versus Shoulder Periarticular Anesthetic Infiltration for Pain Control After Arthroscopic Shoulder Surgery [NCT03691922] | | 62 participants (Actual) | Interventional | 2019-07-06 | Completed |
| Hemodynamic Stability of Bupivacaine With and Without Adrenaline for Paracervical Block for Cervical Conization During General Anesthesia: A Randomized Controlled Double Blinded Study [NCT02368054] | Phase 4 | 34 participants (Actual) | Interventional | 2015-05-31 | Completed |
| Pilot Study: Comparison of Buffered 1% vs. Unbuffered 2% Lidocaine in Pediatric Subjects; Clinical Outcomes [NCT03562481] | Phase 4 | 26 participants (Actual) | Interventional | 2018-07-24 | Completed |
| Bioavailability Comparison of Epinephrine Following a Single Nasal Dose of Microspheres Powder With Epinephrine Intramuscular Injection in Adults With Seasonal Allergic Rhinitis With and Without Nasal Allergen Challenge [NCT04696822] | Phase 1 | 12 participants (Actual) | Interventional | 2020-11-01 | Completed |
| The Application of Recombinant Human Hyaluronidase is Effective for the Use of Local Blocks for Eyelid Surgery [NCT02059694] | | 0 participants (Actual) | Interventional | | Withdrawn |
| Laparoscopically Guided Rectus Sheath Block in Pediatric Appendicitis - a Randomized Control Trial [NCT04717193] | Phase 2 | 100 participants (Anticipated) | Interventional | 2021-05-28 | Recruiting |
| The Bupivacaine Dose Sparing Effect of Intrathecal Epinephrine for Spinal Anesthesia in Total Knee Replacement Arthroplasty [NCT01261078] | | 75 participants (Anticipated) | Interventional | 2010-12-31 | Completed |
| A Randomised Clinical Trial Comparing Endovenous Laser Ablation and Mechanochemical Ablation (ClariVein®) in the Management of Superficial Venous Insufficiency [NCT02627846] | Phase 4 | 150 participants (Actual) | Interventional | 2015-06-01 | Completed |
| The Effect of BMI on Median Effective Dose (ED50) of Intrathecal Hyperbaric Bupivacaine for Total Knee Replacement Arthroplasty [NCT01291186] | | 108 participants (Actual) | Interventional | 2010-01-31 | Completed |
| Comparison of the Analgesic Effect of Femoral Nerve Block, Intraarticular Infiltration or a Combination of Both in the Control of Pain in Total Knee Arthroplasty [NCT01304212] | Phase 4 | 137 participants (Actual) | Interventional | 2011-04-30 | Completed |
| Study of Drug Exposure in Systemic Circulation of Primatene Mist (0.25mg) by Oral Inhalation, Versus Epinephrine Injection (0.30mg) by Intramuscular Injection and ProAir (0.18mg) by Oral Inhalation in Healthy Individuals: A Randomized, Safety Evaluator-bl [NCT04207840] | Phase 4 | 28 participants (Actual) | Interventional | 2019-12-09 | Completed |
| Surgicel; a Probable Analgesic Reservoir for Post-laparoscopic Cholecystectomy Pain Management; Randomized Controlled Double-blind Trial [NCT03730714] | Phase 2/Phase 3 | 90 participants (Actual) | Interventional | 2018-11-15 | Completed |
| An Analysis of the Functional Benefit, Narcotic Use and Time to Discharge Readiness Following the Implementation of a Comprehensive Pain Management Protocol for Primary Total Knee Arthroplasty [NCT02474654] | Phase 4 | 220 participants (Actual) | Interventional | 2015-07-31 | Completed |
| Comparing the Effect of 4% Articaine and 2% Mepivacaine Without Palatal Injection in Pain Assessment During Maxillary Teeth Extraction- A Randomized Clinical Trial [NCT03470532] | Phase 4 | 60 participants (Actual) | Interventional | 2017-02-25 | Completed |
| Comparison of Zero- and Two-centimeter Distance From Sapheno-femoral Junction in Laser Ablation of Long Saphenous Vein Incompetence: Evaluating the Kissing Technique [NCT05707169] | | 800 participants (Anticipated) | Interventional | 2023-01-04 | Active, not recruiting |
| Managing Post Spinal Hypotension During Elective Cesarean Section: Epinephrine Versus Ephedrine, a Randomized Double-blinded Controlled Trial [NCT03704909] | Phase 4 | 143 participants (Actual) | Interventional | 2018-09-01 | Completed |
| Management of Acute Pulmonary Hypertensive Crisis in Children With Known Pulmonary Arterial Hypertension [NCT05439460] | Phase 4 | 15 participants (Actual) | Interventional | 2012-01-31 | Completed |
| Adrenal Artery Ablation for Primary Aldosteronism：A Randomized, Parallel, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Adrenal Artery Ablation（AAA）in the Treatment of Primary Aldosteronism [NCT03653845] | Phase 3 | 40 participants (Anticipated) | Interventional | 2018-07-01 | Recruiting |
| Comparison of the Effects of Two Concentrations of Adrenaline (0.33 mg/l vs 1 mg/l) in the Irrigation Serum of Arthroscopic Shoulder Surgery. [NCT05439213] | | 170 participants (Anticipated) | Interventional | 2022-06-22 | Recruiting |
| Ultrasound-Guided Versus Conventional Method for Caudal Block in Children [NCT03427437] | | 275 participants (Actual) | Interventional | 2017-02-01 | Completed |
| Comparison of the Effect of a Single Shot Saphenous Block With Plain Bupivacaine vs. Protracted Bupivacaine Mixture as a Supplement to Continuous Sciatic Catheter After Major Ankle and Foot Surgery [NCT02346110] | Phase 4 | 40 participants (Actual) | Interventional | 2015-04-30 | Completed |
| Nebulized Hypertonic Saline (3%) Versus Nebulized Adrenaline for Treatment of Bronchiolitis: A Randomized Control Trial [NCT03614273] | | 60 participants (Actual) | Interventional | 2015-03-01 | Completed |
| An Exploratory Phase I Randomized, Single-site, Double-blind, Active-controlled, Parallel-group, Single-administration, Dose-escalation Trial to Investigate the Safety and Tolerability of Neosaxitoxin Alone and in Combination With Bupivacaine (With and Wi [NCT03399435] | Phase 1 | 242 participants (Actual) | Interventional | 2018-01-30 | Terminated(stopped due to The sponsor decided to stop further dosing of healthy volunteers after reviewing the obtained efficacy data. The decision is not related to any safety concern.) |
| Pulpal Blood Flow With the Use of Intra-nasal Anesthetic: a Randomized Double-blind Crossover Study [NCT03368391] | Phase 4 | 25 participants (Anticipated) | Interventional | 2018-01-03 | Not yet recruiting |
| The Effect of Protracted Saphenous Nerve and Obturator Nerve Block Versus Saphenous Nerve Block Versus Local Infiltration Analgesia on Opioid Consumption, Pain, Block Duration of Action and Mobilization After Total Knee Arthroplasty. [NCT02067078] | Phase 4 | 75 participants (Actual) | Interventional | 2014-02-28 | Completed |
| Efficacy of Lidocaine Saline Irrigation in Patients Undergoing Shoulder Arthroscopy: Randomized Controlled Study [NCT05624957] | | 50 participants (Actual) | Interventional | 2022-11-25 | Completed |
| A Randomized, Double-blinded or Evaluator-blinded, Placebo and Active Controlled, Six-arm, Crossover, Single Dose, Dose-ranging Study, for Initial Evaluation of Safety and Efficacy in Asthma Patients [NCT01025648] | Phase 1/Phase 2 | 9 participants (Actual) | Interventional | 2009-12-31 | Terminated(stopped due to Optimization of protocol) |
| Influence of Synacthen Infusion on the Results of Adrenal Venous Sampling in Patient With Primary Aldosteronism [NCT02127840] | Phase 4 | 40 participants (Anticipated) | Interventional | 2011-03-31 | Recruiting |
| Three-level Injection Paravertebral Block Using Paravertebral Catheter Compared to General Anesthesia in Mastectomy Surgery [NCT02065947] | Phase 1/Phase 2 | 60 participants (Actual) | Interventional | 2013-10-31 | Completed |
| Effect of Local Infiltration Anesthesia in a Hip Arthroplasty Fast Track Program. [NCT03513276] | Phase 4 | 63 participants (Actual) | Interventional | 2016-02-29 | Completed |
| Bacteraemia Secondary to Tooth Extraction: a Randomized Clinical Trial on Efficacy of Three Different Chlorhexidine Prophylaxis Protocols [NCT02150031] | Phase 4 | 208 participants (Actual) | Interventional | 2010-12-31 | Completed |
| Epinephrine Inhalation Aerosol USP, an HFA-MDI: Clinical Study-C For Evaluation Of Efficacy And Safety In Asthma Patients [NCT01357642] | Phase 3 | 373 participants (Actual) | Interventional | 2011-07-31 | Completed |
| A 3-month Safety Evaluation Extension to the 12-week E004-C Study in Asthma Patients (A Double Blinded, Placebo-controlled, Parallel, 3-month Safety Study in Adolescent and Adult Patients With Asthma) [NCT01476904] | Phase 3 | 208 participants (Actual) | Interventional | 2011-11-30 | Completed |
| An Open, Randomised, Parallel Group Controlled, Single Centre Safety Study to Assess the Safety and Efficacy of Tri-Solfen in Providing Anaesthesia Prior to Surgical Debridement of Leg Ulcers and Post-operative Pain Relief [NCT03865147] | Phase 2 | 90 participants (Anticipated) | Interventional | 2019-01-15 | Recruiting |
| Randomized, Double Blind Trial of Thoracolumbar Interfascial Plane Block and Erector Spinae Plane Block for Adult Spinal Surgery [NCT03931343] | | 60 participants (Anticipated) | Interventional | 2020-12-31 | Not yet recruiting |
| Local Infiltration Analgesia During Total Knee Arthroplasty - Reduced Opiate Consumption and Faster Mobilisation Postoperatively - Randomized Controlled Trial [NCT01305733] | | 60 participants (Actual) | Interventional | 2011-03-31 | Active, not recruiting |
| Adrenal Venous Sampling Via an Antecubital Approach: A Multicenter Study [NCT03778645] | | 1,500 participants (Anticipated) | Observational | 2018-07-01 | Recruiting |
| How Successful is Supplemental Intraseptal Anaesthesia in Patients With Mandibular Teeth Extraction or Irreversible Pulpitis [NCT03880409] | Phase 1 | 100 participants (Actual) | Interventional | 2019-02-09 | Completed |
| Formulations of Liposomal Local Anesthetics for Dental Anesthesia [NCT01307969] | Phase 1 | 40 participants (Actual) | Interventional | 2007-02-28 | Completed |
| Comparison of Postoperative Pain With Two Different Types of Local Anesthesia in Surgery for a Drooping Eyelid [NCT01350024] | | 34 participants (Actual) | Interventional | 2011-05-01 | Completed |
| Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 5 [NCT00605774] | | 0 participants (Actual) | Interventional | | Withdrawn |
| Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 4 [NCT00608816] | | 0 participants (Actual) | Interventional | | Withdrawn |
| Intraoperative Use of Perineal Block for Hemorrhoidectomy [NCT04288349] | | 100 participants (Anticipated) | Interventional | 2020-02-20 | Recruiting |
| A Randomized, Single-Blinded, Placebo-Controlled Study Evaluating Postoperative Non-Opioid Pain Management Utilizing Local Anesthetics Coupled With Modulated Coagulation [NCT04814433] | Phase 4 | 5 participants (Actual) | Interventional | 2021-03-24 | Terminated(stopped due to Both lack of enrollment as well as study staff turnover) |
| Effectiveness of Bupivacaine With Epinephrine Injections Into the Uterosacral Ligaments for Post-operative Pain Control and the Use of Narcotic Pain Medication Following Robotic Assisted Total Hysterectomies [NCT02230735] | | 0 participants (Actual) | Interventional | 2014-08-31 | Withdrawn(stopped due to Study was never started.) |
| Shamrock Versus Lumbar Ultrasound Trident - Ultrasound Guided Block of the Lumbar Plexus: A Randomized Controlled Trial [NCT02255591] | Phase 4 | 20 participants (Actual) | Interventional | 2015-02-28 | Completed |
| Analgesic Benefit of PECS Blocks for Biceps Tenodesis Shoulder Surgery [NCT02741713] | Phase 3 | 40 participants (Actual) | Interventional | 2016-04-30 | Completed |
| A Randomized Comparison Between 1 Plane - 1 Injection (Cluster Approach) and 2 Plane - 2 Injection Ultrasound-guided Supraclavicular Brachial Plexus Block (US-SCBPB) in Upper Extremity Surgery [NCT02505633] | | 36 participants (Actual) | Interventional | 2015-07-31 | Completed |
| Postoperative Pain Management Following Total Hip Arthroplasty. A Comparison Between Local Infiltration Analgesia and Ultrasound Guided 3-in-1 Block [NCT02568995] | Phase 3 | 55 participants (Actual) | Interventional | 2014-05-31 | Completed |
| Tumescent Lidocaine Bioavailability and Absorption Kinetics:Maximum Safe mg/kg Lidocaine Dosage [NCT00977028] | Phase 1/Phase 2 | 14 participants (Actual) | Interventional | 2005-01-31 | Enrolling by invitation |
| A Single Center, Prospective, Observational Study to Explore and Evaluate the Differences of Cognitive Function and Brain Function Between Non-functioning Adrenal Adenomas and Autonomous Cortisol Secretion Patients, and the Different Treatments Methods on [NCT05357456] | | 62 participants (Anticipated) | Observational | 2021-10-01 | Recruiting |
| Towards Cost-effective Management of Patients With Hypertension Due to Primary Aldosteronism: Adrenal Vein Sampling or Ct-scan? [NCT01096654] | Phase 3 | 200 participants (Actual) | Interventional | 2010-07-31 | Completed |
| Comparison of Perioperative Opioid Consumption Following Pectoral Nerve Block Under General Anesthesia for Breast Cancer Surgery: A Randomized Clinical Trial [NCT02741232] | | 50 participants (Actual) | Interventional | 2016-03-31 | Completed |
| The Use of Tranexamic Acid in Irrigation Fluid to Improve Arthroscopic Visualization in Shoulder Surgery: A Randomized Controlled Trial [NCT04594408] | Phase 4 | 128 participants (Actual) | Interventional | 2020-09-01 | Active, not recruiting |
| Efficacy of Multimodal Peri- and Intraarticular Drug Injections in Total Knee Arthroplasty [NCT00562627] | Phase 4 | 102 participants (Actual) | Interventional | 2007-11-30 | Completed |
| Interest of the Alkalinization of the Adrenaline Lidocaine Solution for Conversion of Epidural Analgesia Into Epidural Anesthesia During an Emergency Caesarean [NCT04255121] | Phase 3 | 400 participants (Actual) | Interventional | 2020-06-22 | Completed |
| Randomized Controlled Trial of Dopamine, Adrenaline, and Blood Transfusion for Treatment of Fluid Refractory Shock in Children With Severe Acute Malnutrition or Severe Underweight and Cholera or Other Dehydrating Diarrheas [NCT04750070] | Phase 3 | 135 participants (Anticipated) | Interventional | 2021-08-17 | Recruiting |
| Randomized Double-blind Clinical Trial Comparing the Cardiovascular Effects of Local Anesthesia Solutions Containing 1:100,000 and 1:200,000 of Epinephrine Concentrations [NCT02735018] | Phase 4 | 40 participants (Actual) | Interventional | 2014-12-31 | Completed |
| Effect of Intrapartum Epidural Fentanyl Upon Breastfeeding in the Immediate Postpartum Period: a Randomized, Controlled, Double-blinded Study [NCT01497509] | | 0 participants (Actual) | Interventional | 2012-05-31 | Withdrawn(stopped due to Study never started) |
| Efficacy of Post-FESS Implantation of Composite Removable Sinus Stent System to Prevent Post-Operative Complications and Revision Surgery [NCT02812199] | | 30 participants (Anticipated) | Interventional | 2016-08-31 | Recruiting |
| A Multi-center, Randomized, Double-blind, Crossover, phase4 Trial to Evaluate the Efficacy on Local Anesthesia and Safety of 2% Lidocaine HCl With Different Epinephrine Concentration in Patients Undergoing Surgical Extraction of Impacted Lower Third Molar [NCT02696369] | Phase 4 | 65 participants (Actual) | Interventional | 2014-12-31 | Completed |
| Does the Addition of Epinephrine to Bilateral Ultrasound Guided Pterygopalatine Ganglion Block Reduce Bleeding During Functional Endoscopic Sinus Surgery (FESS)? A Pilot Study [NCT03970655] | Phase 1/Phase 2 | 80 participants (Anticipated) | Interventional | 2019-09-25 | Recruiting |
| Postmortem Evaluation of Adrenal and Other Endocrine Tumors in Patients With Sudden Death Without Definitive Causative Diagnosis (PEA-SuddenDeath) [NCT05446779] | | 400 participants (Anticipated) | Observational | 2022-06-03 | Recruiting |
| A Randomized Comparison Between 1 Plane-2 Injection and 2 Plane-2 Injection Ultrasound-guided Supraclavicular Brachial Plexus Block (US-SCBPB) in Upper Extremity Surgery [NCT02533557] | | 70 participants (Actual) | Interventional | 2015-08-31 | Completed |
| A Phase 1 Comparative Bioavailability Study of Inhaled Epinephrine and Intramuscular Epinephrine Administered to Healthy Adults [NCT05152901] | Phase 1 | 23 participants (Actual) | Interventional | 2022-01-06 | Completed |
| Intraoperative Injection of Exparel Effect on Postoperative Opioid Use in Thyroid and Parathyroid Surgery [NCT04085913] | Early Phase 1 | 100 participants (Anticipated) | Interventional | 2019-09-30 | Enrolling by invitation |
| ''To Compare the Response Rate of Noradrenaline vs. Terlipressin in Hepatorenal Syndrome in Patients With Acute on Chronic Liver Failure' [NCT02573727] | | 120 participants (Actual) | Interventional | 2015-10-31 | Completed |
| Prospective, Randomized Trial of Hemospray Plus Epinephrine Injection Versus Endoscopic Hemoclip Plus Epinephrine Injection in Nonvariceal Upper Gastrointestinal Bleeding [NCT02537353] | Phase 4 | 40 participants (Anticipated) | Interventional | 2015-09-30 | Not yet recruiting |
| Study of Tramadol Addiction Impact on Dental Anesthesia Succes. [NCT05908305] | Phase 4 | 300 participants (Anticipated) | Interventional | 2023-06-10 | Not yet recruiting |
| Vasopressin, Epinephrine, and Corticosteroids for Inhospital Cardiac Arrest: A Multicenter Randomized Controlled Trial [NCT00729794] | Phase 3 | 300 participants (Actual) | Interventional | 2008-09-30 | Completed |
| A Multicenter Double-Blind Randomized Placebo Controlled Two-Arm Study Evaluating the Safety and Efficacy of the Iontophoretic Administration of Lidocaine and Epinephrine Using Lidocaine Iontophoretic Drug Delivery System (IDDS) to Provide Local Anesthesi [NCT00889642] | Phase 2 | 90 participants (Anticipated) | Interventional | 2009-05-31 | Completed |
| Efficacy and Safety of Percutaneous Superselective Adrenal Arterial Embolization in the Treatment of Primary Aldosteronism With Bilateral Idiopathic Hyperaldosteronism: A Prospective Cohort Study [NCT05186675] | | 50 participants (Anticipated) | Interventional | 2022-01-01 | Enrolling by invitation |
| Anesthetic Efficacy of %4Alexadricaine Versus %2 Mepicaine-L for Infiltration Anesthesia in Extraction of Maxillary First Primary Molars in Children [NCT04477317] | Phase 3 | 10 participants (Actual) | Interventional | 2021-08-01 | Completed |
| Adrenal Venous Sampling in Patients With Overt or Subclinical Cushings Syndrome, and Bilateral Adrenal Tumors [NCT02543697] | | 30 participants (Anticipated) | Interventional | 2015-02-28 | Recruiting |
| Periarticular Injection and Hamstring Block Versus Placebo for Pain Control in Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial [NCT05248724] | | 44 participants (Actual) | Interventional | 2017-08-01 | Completed |
| The Use of Epinephrine Infusion for Prophylaxis Against Maternal Hypotension During Cesarean Delivery: a Randomized Controlled Dose-finding Trial [NCT05051150] | Phase 4 | 18 participants (Actual) | Interventional | 2021-09-15 | Terminated(stopped due to tachycardia and arrhythmia in the high doses groups 0.05 and 0.07 necessitate stopping the infusion) |
| Surgery of Subclinical Cortisol Secreting Adrenal Incidentalomas [NCT02364089] | | 78 participants (Actual) | Interventional | 2015-04-09 | Completed |
| Effect of Chronic Catecholamine Overproduction on Brown Adipose Tissue [NCT01949714] | | 10 participants (Actual) | Observational | 2013-08-31 | Completed |
| The Hemostatic and Hemodynamic Effects of Adrenaline During Endoscopic Sinus Surgery: Randomized Clinical Trial [NCT00852410] | Phase 3 | 140 participants (Anticipated) | Interventional | 2009-03-31 | Not yet recruiting |
| Pharmacokinetic Interaction Effects of Combined Fentanyl and Adrenalin in Epidural Analgesia During Child Birth [NCT00685672] | Phase 4 | 40 participants (Actual) | Interventional | 2008-08-31 | Completed |
| "Clinical Trial Protocol of Primary Study on Efficacy and Safety of Telesurgery for Patients With Tumors of the Urinary System Using Chinese Independently Developed MicroHand Surgical Robot System" [NCT04570176] | | 1 participants (Actual) | Interventional | 2020-08-27 | Completed |
| Nebulized Adrenalin and Oral Betamethasone in Children With Bronchiolitis Attending Pediatric Emergencies : a Multicentre Randomized Controlled Trial [NCT02586961] | Phase 2/Phase 3 | 195 participants (Actual) | Interventional | 2015-10-31 | Terminated(stopped due to Removal of Adrénaline lots for safety reasons.) |
| 7% Hypertonic Saline for Acute Bronchiolitis: A Randomized Controlled Trial [NCT01871857] | Phase 4 | 101 participants (Actual) | Interventional | 2010-11-30 | Completed |
| Comparative Evaluation of Handling Characteristics of Two Adrenaline Autoinjectors,EpiPen in Comparison With Jext; the HEJ-study [NCT01887405] | Phase 4 | 91 participants (Actual) | Interventional | 2012-01-31 | Completed |
| Assessment of the Operative Course in Connection With Removal of Lower Third Molars With Particular Consideration to the Occurence of Pain and Swelling [NCT00805298] | | 154 participants (Actual) | Interventional | 2008-08-31 | Completed |
| Phase II Clinical Trial for a Stepwise Progression in the Treatment of Cardiogenic Shock [NCT02591771] | Phase 2 | 24 participants (Actual) | Interventional | 2015-10-31 | Completed |
| Bronchiolitis All-study, SE-Norway What is the Optimal Inhalation Treatment for Children 0-12 Months With Acute Bronchiolitis? [NCT00817466] | Phase 4 | 500 participants (Anticipated) | Interventional | 2010-01-31 | Active, not recruiting |
| Hemostatic and Hemodynamic Effects of Intranasal Injection Compared to Topical Administration of Epinephrin in Endoscopic Sinus Surgery [NCT01075581] | | 50 participants (Anticipated) | Interventional | 2010-04-30 | Not yet recruiting |
| Nebulized 5% Hypertonic Saline for Infirmary Treatment of Acute Infant Bronchiolitis: A Randomized Trial [NCT01016249] | Phase 4 | 187 participants (Actual) | Interventional | 2007-04-30 | Completed |
| Phase 2, Single-Center, Placebo-Controlled Study of the Effects of Combined Administration of Vasopressin, Methylprednisolone, and Epinephrine During Cardiopulmonary Resuscitation on Survival After Cardiac Arrest [NCT00411879] | Phase 2 | 100 participants (Actual) | Interventional | 2006-06-30 | Completed |
| Anesthetic Efficacy of 4% Articaine (Mandibular Infiltration) and 2% Lidocaine (Alveolar Nerve Block), Associated With 1:100.000 Epinephrine, in Lower Molars With Irreversible Pulpits [NCT01912755] | Phase 4 | 50 participants (Actual) | Interventional | 2010-02-28 | Completed |
| Compare Articaine 1:100.000, 4% Epinephrine, Subperiosteal With Loco-regional Anesthesia for Placing Dental Implants in Posterior Mandible - Double-Blinded Randomized Clinical Trial [NCT01963754] | Phase 4 | 88 participants (Anticipated) | Interventional | 2017-04-01 | Active, not recruiting |
| Phase 4 Study of Comparison of Preincisional Infiltrated Dexmedetomidine and Lidocaine Plus Adrenaline for Surgical Conditions and Postoperative Analgesic Consumption in Nasal Sephoplasty Surgery. [NCT01964586] | Phase 4 | 60 participants (Actual) | Interventional | 2013-03-31 | Completed |
| The Effect of Topical Administration of Tranexamic Acid, Adrenaline and Bupivacain on Postoperative Bleeding and Pain in Patients Undergoing Breast Surgery. A Four-armed Placebo-controlled Double Blinded Randomized Study [NCT01964781] | Phase 4 | 30 participants (Actual) | Interventional | 2013-08-31 | Completed |
| Does Saphenous Nerve Block Improve Analgesia After Total Knee Replacement When Used in Combination With Local Infiltration Analgesia? A Prospective Randomised Double Blinded Trial. [NCT01991288] | Phase 4 | 20 participants (Actual) | Interventional | 2012-11-30 | Completed |
| Regional Anesthesia Block of the Transversus Abdominis Plane in Children Undergoing Gastric Tube Insertion [NCT00564655] | Phase 3 | 3 participants (Actual) | Interventional | 2007-10-31 | Terminated |
| Phase I/II Study Epinephrine Inhalation Aerosol USP, an HFA-MDI Clinical Study-B for Assessment of Pharmacokinetics [NCT01143051] | Phase 1/Phase 2 | 24 participants (Actual) | Interventional | 2010-01-31 | Completed |
| Efficacy of Hemostasis by Soft Coagulation Using Endoscopic Hemostatic Forceps in Comparison With Argon Plasma Coagulation for Acute Peptic Ulcer Bleeding [NCT02020603] | | 151 participants (Actual) | Interventional | 2012-01-31 | Completed |
| Effects of Adrenaline Infiltration on Surgical Field of View in Endoscopic Sinus Surgery [NCT05867342] | Phase 4 | 40 participants (Actual) | Interventional | 2017-05-12 | Completed |
| The Effect of Oral Midodrine Versus Oral Desmopressin Acetate Use for Liberation From IV Noradrenaline in Intensive Care Unit Patients Recovering From Spinal Shock . [NCT04586790] | Phase 2 | 90 participants (Anticipated) | Interventional | 2020-10-15 | Recruiting |
| Comparison Between Effect of Adrenaline and Without Adrenaline in Tumescent Solutions on Bleeding Control of Skin Graft Donor Site. [NCT04590638] | | 56 participants (Actual) | Interventional | 2020-10-17 | Completed |
| A Randomised, Open Label Study to Compare the Efficacy of Nor Adrenaline and Terlipressin vs Step up Terlipressin Therapy in Hepatorenal Syndrome [NCT01649037] | | 0 participants (Actual) | Interventional | 2012-08-31 | Withdrawn(stopped due to lack of funds) |
| Topical Adrenaline Versus Warm Saline Solution for Minimizing Intraperitoneal Bleeding During Caesarian Delivery for Placenta Previa / Accreta Spectrum ( PAS): A Randomized Controlled Study [NCT06030479] | | 84 participants (Anticipated) | Interventional | 2023-02-01 | Recruiting |
| Prophylactic Racemic Epinephrine for the Prevention of Dysphagia in Patients Undergoing Anterior Cervical Discectomy and Fusion: A Randomized Control Trial [NCT02724761] | | 90 participants (Anticipated) | Interventional | 2016-09-30 | Not yet recruiting |
| A Prospective Randomized Case Series Comparison on the Clinical Efficacy of Exparel Local Anesthetic in Total Knee Arthroplasty Patients [NCT02765815] | Phase 4 | 0 participants (Actual) | Interventional | 2016-02-29 | Withdrawn(stopped due to competing protocol) |
| An Parallel Control Clinical Trail on Effects of Adrenal Artery Ablation and Adrenalectomy in Patients With Primary Aldosteronism [NCT04269928] | | 60 participants (Anticipated) | Interventional | 2016-01-19 | Recruiting |
| Pectoral Nerve (PECS) Block for Cardiac Implantable Electronic Devices (CIED) Implantation Surgery [NCT04577690] | Phase 4 | 48 participants (Anticipated) | Interventional | 2019-12-01 | Recruiting |
| Assessment and Evaluation of Pharmacokinetic Profile of E004 in Healthy Adults (A Randomized, Evaluator-Blind, Single-Dose, Two Arm, Crossover, PK Study in Healthy Volunteers) [NCT01737892] | Phase 1/Phase 2 | 21 participants (Actual) | Interventional | 2012-11-30 | Terminated(stopped due to unable to validate analytical method) |
| Fluid Management in Patients Undergoing Cardiac Surgery - Effects of an Acetate Versus Lactate Buffered Balanced Infusion Solution on Hemodynamic Stability, a Randomized Controlled Double-blind Trial [NCT02895659] | Phase 4 | 150 participants (Actual) | Interventional | 2016-12-01 | Completed |
| Efficacy of Intracoronary Adrenaline and Its Comparison With Intracoronary Adenosine in the Treatment of No-Reflow in Normotensive Patients With Acute Coronary Syndrome [NCT04699110] | Phase 4 | 201 participants (Actual) | Interventional | 2021-01-01 | Completed |
| Adrenal Scans With Radioiodine-Labeled Norcholesterol (NP-59) [NCT00591643] | Phase 1 | 93 participants (Actual) | Interventional | 1977-07-31 | Completed |
| Comparative Effect of Palatal Injection on Pain Perception in Pediatric Patient [NCT06025825] | | 96 participants (Anticipated) | Observational [Patient Registry] | 2023-05-02 | Recruiting |
| Prophylactic Tranexamic Acid Versus Adrenaline for Bleeding Prevention During Flexible Bronchoscopy: a Double Blind, Randomized Controlled Trial [NCT06145191] | | 840 participants (Anticipated) | Interventional | 2023-12-18 | Recruiting |
| A Randomized Controlled Trial Comparing Epinephrine and Dexamethasone to Placebo in the Treatment of Infants With Bronchiolitis [NCT03567473] | Phase 3 | 864 participants (Anticipated) | Interventional | 2018-12-13 | Recruiting |
| Hemodynamics and Extravascular Lung Water in Acute Lung Injury: A Prospective Randomized Controlled Multicentered Trial of Goal Directed Treatment of EVLW Versus Standard Management for the Treatment of Acute Lung Injury [NCT00624650] | Phase 2 | 33 participants (Actual) | Interventional | 2008-02-29 | Completed |
| Effect of Dexmedetomidine as Adjuvant to Ropivacaine for Brachial Plexus Block [NCT05767827] | | 40 participants (Anticipated) | Interventional | 2023-02-01 | Recruiting |
| Comparison of Infraclavicular and Supraclavicular Block Approaches in Ultrasound Guided Brachial Plexus Block [NCT04784104] | Phase 4 | 70 participants (Anticipated) | Interventional | 2021-03-05 | Not yet recruiting |
| Can the Risk of RD and Hypoglycemia in Children Born at Elective CS be Reduced by Injection of Adrenaline [NCT00322660] | | 270 participants (Actual) | Interventional | 2006-06-30 | Completed |
| The Effect of Intraoperative Low Dose Adrenaline on Bleeding in Total Hip Arthroplasty - a Randomized Placebo-controlled Trial [NCT01708642] | Phase 3 | 106 participants (Actual) | Interventional | 2012-11-30 | Completed |
| Parameters in Fractional Laser Assisted Delivery of Topical Anesthetics: Role of Anesthetic and Application Time [NCT03279757] | Phase 4 | 15 participants (Actual) | Interventional | 2016-10-01 | Completed |
| Phase 3 Study of Adrenaline and Milrinone in Patients With Myocardial Dysfunction [NCT00446017] | Phase 3 | 60 participants | Interventional | 2003-06-30 | Completed |
| Randomized Controlled Trial Examining the Effect of Subcutaneous Xylocaine 2% on the Incidence of Vasovagal Reactions and Pain Intensity During Femoral Artery Sheath Removal. [NCT00465439] | | 78 participants (Actual) | Interventional | 2007-05-31 | Completed |
| Effect of Adrenaline Concentration in Tumescence Solution on Intraoperative Hemodynamics of Liposuction Patients: A Randomized Controlled Trial [NCT05822765] | Phase 3 | 40 participants (Actual) | Interventional | 2023-05-01 | Completed |
| Selective Trunk Block Versus Hybrid Interscalene-Supraclavicular Brachial Plexus Block for Anaesthesia of the Entire Upper Extremity: A Randomized Double-Blind Controlled Trial [NCT04908371] | | 0 participants (Actual) | Interventional | 2022-12-31 | Withdrawn(stopped due to Published data indicated Selective Trunk Block is a better choice) |
| Intracoronary Administration of Epinephrine and Verapamil in the Refractory No-reflow Phenomenon in Patients With Acute Myocardial Infarction: The EPIVER Randomized Controlled Trial [NCT04573751] | | 104 participants (Actual) | Interventional | 2020-12-30 | Active, not recruiting |
| Evaluating the Effectiveness of Local Multimodal Injection in Controlling Pain, Limiting Complications, and Reducing Cost as Compared to Regional Anesthesia for Treating Rotational Ankle Fractures. [NCT05019638] | Early Phase 1 | 200 participants (Anticipated) | Interventional | 2021-05-15 | Enrolling by invitation |
| A Comparative Study for Evaluation of the Analgesic Profile of Ultrasound-Guided Modified Pectoral Nerves Block Versus Serratus Plane Block in Major Breast Cancer Surgery [NCT02946294] | Phase 2 | 90 participants (Actual) | Interventional | 2016-10-31 | Completed |
| Endoscopic Ultrasound-guided Radiofrequency Ablation as a Novel Treatment Option Compared With Adrenalectomy in Left-sided Primary Aldosteronism [NCT05368090] | | 40 participants (Anticipated) | Interventional | 2022-06-03 | Recruiting |
| A Prospective Randomized Comparison of the Effects of Lidocaine and Levobupivacaine on Block Dynamics After a Subparaneural Popliteal Sciatic Nerve Block [NCT04397484] | Phase 4 | 40 participants (Anticipated) | Interventional | 2023-09-20 | Recruiting |
| Articaine Efficacy and Safety for 3 Years Old Children: A Clinical Randomized Control Trial [NCT05839548] | Phase 3 | 200 participants (Anticipated) | Interventional | 2023-06-01 | Not yet recruiting |
| A Randomised, Double-blinded Multi-centre Trial Comparing Vasopressin and Adrenaline in Patients With Cardiac Arrest at the Emergency Department. (Preadmission Intravenous Vasopressin, Adrenaline Outcome Trial: PIVOT vII) [NCT00358579] | Phase 3 | 727 participants (Actual) | Interventional | 2006-03-31 | Completed |
| Analgesic Efficacy of a Combination of Fentanyl and Lidocaine for Maxillary Infiltration in Teeth With Irreversible Pulpitis [NCT01794533] | Phase 2 | 64 participants (Actual) | Interventional | 2012-10-31 | Completed |
| Surgical Treatment of Carpal Tunnel Syndrome: Local Anesthesia With Epinephrine x Intravenous Regional Anesthesia. Randomized Clinical Trial. [NCT02986347] | | 78 participants (Actual) | Interventional | 2017-05-27 | Completed |
| Effect of Lidocaine and Adrenaline Soaked Gauze Versus Normal Saline Soaked at Skin Graft Donor Site of Thigh: A Randomized Control Trial [NCT04344483] | | 60 participants (Actual) | Interventional | 2019-12-10 | Completed |
| Comparison of Topical Vasoconstriction in Endoscopic Sinus Surgery: Cocaine Versus Adrenaline [NCT01706952] | Phase 4 | 45 participants (Actual) | Interventional | 2012-12-31 | Completed |
| Perioperative Analgesia for Total Hip Arthroplasty: Lumbar Plexus Block Using Shamrock Technique Versus Fascia Iliaca Block [NCT04670497] | | 70 participants (Actual) | Interventional | 2018-07-01 | Completed |
| The Effect of Intranasal Irrigation With Adrenaline Solution on Intraoperative Visualization and Bleeding During Functional Endoscopic Sinus Surgery [NCT04551703] | Phase 1 | 60 participants (Actual) | Interventional | 2016-07-01 | Completed |
| Comparison of 2 Application Techniques for LET (Lidocaine 4%; Epinephrine 0.1%; Tetracaine 0.5%) Gel Used Prior to Simple Laceration Repair [NCT04536493] | Phase 4 | 48 participants (Actual) | Interventional | 2019-06-19 | Completed |
| Postoperative Analgesia After Total Hip Arthroplasty. A Comparison of Continuous Epidural Infusion and Wound Infiltration With Intraarticular Bolus Injection. [NCT00289419] | Phase 4 | 80 participants (Actual) | Interventional | 2005-02-28 | Completed |
| Low Dose Adrenaline, Promethazine, & Hydrocortisone (Alone and in Combination) to Prevent Acute Adverse Reactions to Antivenom in People Bitten by Snakes: Randomised, Double Blind, Placebo-Controlled Trial [NCT00270777] | Phase 4 | 1,000 participants (Anticipated) | Interventional | 2005-03-31 | Completed |
| Safety and Efficacy of Cocktail Periarticular Injection for Pain Management in Simultaneous Bilateral Total Knee Arthroplasty- A Prospective, Randomized Trial [NCT02270437] | Phase 4 | 55 participants (Actual) | Interventional | 2014-06-30 | Completed |
| Does the Addition of Epinephrine Increase the Duration of Intrathecal Hyperbaric Bupivacaine for Repeat Cesarean Section? [NCT02369510] | Phase 4 | 68 participants (Actual) | Interventional | 2015-02-28 | Completed |
| Buffered vs Unbuffered Local Anesthesia Using Lidocaine, Carbocaine, and Articaine in Mandibular Molars Diagnosed With Symptomatic Irreversible Pulpitis [NCT06047366] | Phase 4 | 60 participants (Anticipated) | Interventional | 2023-12-05 | Recruiting |
| The Effect and Safety of Low Dose Nebulized Epinephrine in the Treatment of Croup [NCT01664507] | Phase 4 | 84 participants (Anticipated) | Interventional | 2016-01-31 | Recruiting |
| "Hemodynamic and Electrocardiographic Effects of Hyaluronidase Associated With Local Anaesthetics: a Double-blind Split-mouth Controlled Trial." [NCT01719978] | Phase 4 | 20 participants (Actual) | Interventional | 2007-10-31 | Completed |
| Sciatic Nerve Block for Ankle/Foot Surgeries. A Comparison Between a Premixed Solution of Lidocaine Plus Bupivacaine and Consecutive Infiltration of Lidocaine and Bupivacaine. A Double Blinded Randomised Controlled Prospective Study [NCT01756443] | Phase 4 | 40 participants (Actual) | Interventional | 2011-08-31 | Completed |
| Onset and Duration of Effect of Lidocaine, Bupivacaine, and Lidocaine/Bupivacaine Mixture With Epinephrine. [NCT01243112] | Phase 4 | 25 participants (Actual) | Interventional | 2010-05-31 | Completed |
| A Prospective, Multicenter Study to Evaluate Effectiveness and Safety of Tymbion Iontophoresis and Tympanostomy Tube Placement Using the Tula Iontophoresis and Tube Delivery Systems for Adults in an Office Setting [NCT03119181] | Phase 2 | 40 participants (Actual) | Interventional | 2017-04-27 | Completed |
| A Comparison of Tumescence in Breast Reduction Surgery [NCT01602692] | Phase 4 | 40 participants (Actual) | Interventional | 2012-08-31 | Completed |
| Bupivacaine Liposome Suspension Versus a Concentrated Multi Drug Periarticular Injection in 70 Patients Undergoing Total Knee Arthroplasty Without Femoral Nerve Block: a Double-blinded, Randomized Clinical Trial [NCT02299349] | | 70 participants (Actual) | Interventional | 2013-08-31 | Completed |
| Postoperative Analgesia After Total Knee Arthroplasty. A Comparison of Continuous Epidural Infusion and Wound Infiltration With Continuous Intraarticular Infusion [NCT00421967] | Phase 4 | 80 participants (Actual) | Interventional | 2007-01-31 | Terminated(stopped due to Interim analysis) |
| Tranexamic Acid Versus Adrenaline for Controlling Iatrogenic Endobronchial Bleeding: a Double Blind, Randomized Controlled Trial [NCT04771923] | | 130 participants (Actual) | Interventional | 2021-02-22 | Completed |
| Epinephrine Inhalation Aerosol USP, an HFA-MDI CLINICAL STUDY-B2 FOR ASSESSMENT OF PHARMACOKINETICS (A Randomized, Evaluator-Blind, Single-Dose, Two Arm, Crossover, PK Study in Healthy Volunteers) [NCT01188577] | Phase 1/Phase 2 | 23 participants (Actual) | Interventional | 2010-08-31 | Completed |
| Efficacy of Nebulised Hypertonic Saline (3%) Among Children With Mild to Moderately Severe Bronchiolitis - A Double Blind Randomized Controlled Trial. [NCT01276821] | Phase 4 | 100 participants (Actual) | Interventional | 2011-01-31 | Completed |
| A Randomized Controlled Trial of a Full and a Fractional Ablative Carbon Dioxide Laser as Pretreatment for Photodynamic Therapy in the Management of Superficial Non Melanoma Skin Cancer [NCT03012009] | | 16 participants (Actual) | Interventional | 2014-09-30 | Completed |
| Pharmacokinetics and Pharmacodynamics for Levobupivacaine With and Without Epinephrine After Ultrasound Guided Erector Spinae Plane Block [NCT04799184] | Phase 4 | 38 participants (Anticipated) | Interventional | 2019-04-03 | Recruiting |
| Comparison of Adductor Canal Block Combined With IPACK Block and Adductor Canal Block Combined With PCI for Postoperative Analgesia and Function Recovery Following Total Knee Arthroplasty:A Prospective, Double-Blind, Randomized Controlled Study [NCT05943080] | | 159 participants (Anticipated) | Interventional | 2023-06-01 | Active, not recruiting |
| Comparison the Effect of Lidocaine (With Epinephrine) With and Without Sufentanil on the Rate of Anesthesia of Intra-ligamentary Injection in Teeth With Irreversible Pulpitis [NCT01572116] | Phase 2 | 60 participants (Actual) | Interventional | 2010-01-31 | Completed |
| Comparison of Plasma Concentrations of Levobupivacaine With and Without Epinephrine for Transversus Abdominis Plane Block Under Ultrasound. [NCT01596998] | Phase 4 | 11 participants (Actual) | Interventional | 2011-12-31 | Completed |
| Fertility and Pregnancy in Patients With Classic Congenital Adrenal Hyperplasia [NCT06153043] | | 55 participants (Anticipated) | Observational | 2023-12-31 | Not yet recruiting |
| Anesthetic Efficacy of 4% Buffered Lidocaine in Emergency Patients With Facial Swelling. [NCT01981772] | | 88 participants (Actual) | Interventional | 2013-03-31 | Completed |
| Characterizing and Comparing the Duration of Local Anesthetic in Dermatologic Surgery [NCT05767749] | Phase 4 | 75 participants (Actual) | Interventional | 2023-03-14 | Completed |
| A Comparison of Ultrasound Guided Transversus Abdominis Plane Nerve Block Technique Versus Laparoscopic Transversus Abdominis Plane Nerve Block Technique Versus No Block on Postoperative Opioid Consumption After Major Colorectal Surgery [NCT02538679] | | 127 participants (Actual) | Interventional | 2015-08-07 | Completed |
| An Open-label, Cohort Study on Effects and Long-term Prognosis of Adrenal Artery Ablation and Spironolactone in Patients With Primary Aldosteronism [NCT04409431] | | 60 participants (Anticipated) | Interventional | 2019-12-01 | Recruiting |
| Efficacy of External Nasal Nerve Block on Postoperative Agitation Following Nasal Surgeries Under General Anesthesia. Randomized, Controlled Trial [NCT03069027] | | 100 participants (Actual) | Interventional | 2016-08-15 | Completed |
| Early Ultrasound-guided Nerve Block for Painful Hand Injuries in the Emergency Department [NCT03195413] | | 15 participants (Actual) | Interventional | 2017-07-01 | Completed |
| Adductor Canal Block and Functional Recovery After Total Knee Arthroplasty. A Double-Blind, Randomized Controlled Trial [NCT02411149] | Phase 4 | 200 participants (Actual) | Interventional | 2014-04-30 | Completed |
| Comparison of Two Different Concentrations of Local Anesthetic in Patient Reported Pain in Oculoplastic Surgery [NCT06121141] | Phase 4 | 30 participants (Anticipated) | Interventional | 2023-08-07 | Enrolling by invitation |
| Clinical Effectiveness of Erector Spinae Plane Block in Peri-operative Analgesia for Laparoscopic Kidney Procedures [NCT03874091] | | 62 participants (Actual) | Interventional | 2019-01-15 | Completed |
| Role of Adrenaline in the Inflammatory Response in People With Diabetes Mellitus Type 1, and Healthy Individuals [NCT05990933] | | 30 participants (Anticipated) | Interventional | 2023-09-30 | Not yet recruiting |
| Evaluation of Cardiac Arrhythmias in Hand Surgery Using Local Anesthesia With Adrenaline [NCT04029610] | | 110 participants (Actual) | Interventional | 2018-08-14 | Completed |
| Pharmacokinetics of Intramuscular Adrenaline in Food--Allergic Teenagers: Does Dose Matter? [NCT03366298] | Phase 4 | 12 participants (Actual) | Interventional | 2017-11-24 | Completed |
| The Effects of Injection Site Cooling and Solution Buffering on Perceived Pain During Local Anesthesia Administration [NCT04991597] | | 0 participants (Actual) | Interventional | 2022-01-01 | Withdrawn(stopped due to Shift in research focus) |
| Phase 3 Study of Ropivacaine (With Epinephrine) in BABA Endoscopic and Robotic Thyroidectomy [NCT02112370] | Phase 3 | 148 participants (Actual) | Interventional | 2014-05-31 | Completed |
| Subcutaneous Tranexamic Acid in Nasal Mohs Local Flap Reconstruction: Perioperative Bleeding, Edema, and Ecchymosis [NCT06057675] | Phase 2 | 100 participants (Anticipated) | Interventional | 2023-12-31 | Not yet recruiting |
| The Effectiveness of Automated Soft Tissue Vibration in Reducing Pain and Accelerating Action of Intraoral Local Anesthesia Injections in Adult Dental Patients. A Randomized Crossover Clinical Trial. [NCT03839134] | | 166 participants (Actual) | Interventional | 2019-03-20 | Completed |
| The Role of Hypertonic Dextrose Spray as Endoscopic Topical Hemostatic Agent for Acute Non-Variceal Upper Gastrointestinal Bleeding: A Randomized Controlled Trial [NCT04979273] | | 66 participants (Anticipated) | Interventional | 2021-03-01 | Recruiting |
| Fast-track Rehabilitation Protocol for Total Knee Arthroplasty: A Randomized Controlled Trial Comparing Local Infiltration Analgesia With Femoral Nerve Block [NCT01966263] | Phase 4 | 80 participants (Actual) | Interventional | 2013-11-30 | Completed |
| Alkalinization of Adrenalized Lidocaine in Extending Epidural Analgesia for Extremely Urgent Cesarean Section During Labor: a Randomized Controlled Trial. [NCT05313256] | Phase 2/Phase 3 | 66 participants (Anticipated) | Interventional | 2022-07-14 | Recruiting |
| The Use of Epinephrine Infusion for Prophylaxis Against Maternal Hypotension During Cesarean Delivery: a Randomized Controlled Dose-finding Trial [NCT05279703] | Phase 4 | 276 participants (Anticipated) | Interventional | 2022-03-21 | Recruiting |
| Comparison of Different Approaches for Supraclavicular Block and Their Effects on Diaphragm Muscle Function Evaluated With Diaphragm Thickening Fraction [NCT04756050] | Phase 4 | 90 participants (Actual) | Interventional | 2021-02-16 | Completed |
| Risk Factors and Postoperative Complications of Reperfusion Syndrome and Vasoplegic Syndrome in Patients With Vasoactive Support During Liver Transplant Surgery [NCT05658120] | | 246 participants (Actual) | Observational | 2022-12-13 | Completed |
| Multicenter, Randomized, Split-mouth Study to Evaluate the Acceptance and Preference of Lidocaine Gel Compared to Injection Anesthesia After Non Surgical Periodontal Treatment [NCT03354312] | Phase 4 | 94 participants (Actual) | Interventional | 2017-12-05 | Completed |
| A Prospective Randomized, Double-blind Study of the Anesthetic Efficacy of Buffered Articaine as a Primary Buccal Infiltration of the Mandibular First Molar. [NCT01862614] | Phase 4 | 80 participants (Actual) | Interventional | 2013-04-30 | Completed |
| Epinephrine in the Pediatric Intensive Care Unit: A Dose-Effect Trial (EPI Dose) [NCT05327556] | Phase 2 | 86 participants (Anticipated) | Interventional | 2023-02-08 | Enrolling by invitation |
| Evaluation of New Methods for Prediction of Fetal Lung Maturity in Diabetic Mothers [NCT03159234] | | 54 participants (Actual) | Interventional | 2016-04-30 | Completed |
| CLINICAL STUDY-B3 FOR ASSESSMENT OF PHARMACOKINETICS, A Randomized, Evaluator-Blind, Single-Dose, Three Arm, Crossover,PK Study in Healthy Volunteers [NCT01255709] | Phase 2 | 24 participants (Actual) | Interventional | 2010-12-31 | Completed |
| Incident and Extent of Pulse Alteration During Administration of Various Modes of Local Anesthesia in Children During Routine Dental Treatment [NCT02328729] | | 300 participants (Anticipated) | Observational | 2015-01-31 | Not yet recruiting |
| Articaine Success in Pulpectomy of Primary Molars With Irreversible Pulpitis in Children Under Four Years: a Randomized Controlled Trial [NCT05944341] | | 164 participants (Anticipated) | Interventional | 2023-06-01 | Recruiting |
| Articaine 4% Efficacy and Safety in Extraction and Pulpotomy of Primary Molars of Children Below the Age of Four Years. [NCT05101785] | | 292 participants (Anticipated) | Interventional | 2021-11-01 | Not yet recruiting |
| Lidocaine With Epinephrine vs. Bupivacaine With Epinephrine as Local Anesthetic Agents in Wide-awake Hand Surgery: an Outcome Study of Patients' Pain Perception. [NCT02315573] | | 61 participants (Actual) | Interventional | 2014-10-31 | Completed |
| Complication in Laparoscopic Renal and Adrenal Surgery (CLARAS): an International Multicenter Study [NCT05322265] | | 350 participants (Anticipated) | Observational | 2017-04-01 | Recruiting |
| An Open-label, Prospective, Controlled Clinical Trial on Effects and Safety of Adrenal Artery Ablation (Triple A) for Primary Aldosteronism [NCT03398785] | Phase 3 | 66 participants (Actual) | Interventional | 2017-10-01 | Completed |
| Levosimendan Versus Adrenaline in Patients With Low Left Ventricular Function Undergoing Elective On-Pump Coronary Artery Bypass Graft Surgery. A Randomized Controlled Study [NCT05222256] | | 52 participants (Anticipated) | Interventional | 2022-03-31 | Not yet recruiting |
| Comparison of the Effect of Vasopressin, Steroid, and Epinephrine Treatment in Patients With Out-of-hospital Cardiac Arrest: Multi-center, Double Blind, Randomized, Placebo-controlled Study [NCT03317197] | Phase 4 | 834 participants (Anticipated) | Interventional | 2018-01-01 | Recruiting |
| A Randomized Clinical Trial to Compare the Addition of Epinephrine (no Epinephrine, 100mcg, and 200mcg) to the Standard Dose of Hyperbaric Bupivacaine 12mg, Fentanyl 20mcg and Morphine 150mcg in Scheduled C-sections. [NCT03335293] | Phase 4 | 0 participants (Actual) | Interventional | 2019-10-31 | Withdrawn(stopped due to Due to FDA constraints on the off label use of the medications we will not be able to conduct this evaluation.) |
| The Impact of Retropubic Lidocaine vs Saline on Postoperative Urinary Retention Following Midurethral Sling: A Randomized Placebo Controlled Trial [NCT03913845] | Phase 4 | 150 participants (Anticipated) | Interventional | 2019-11-25 | Recruiting |
| Adrenal Artery Ablation Treats Primary Aldosteronism With Resistant Hypertension (AAA-RHT) [NCT04345198] | | 36 participants (Actual) | Interventional | 2017-10-01 | Completed |
| Impact of intRacoronary adrEnaline on Myocardial reperfuSion in STEMI paTients With Persistent Impaired cORonary Flow After pErcutaneous Coronary Intervention: the RESTORE-SIRIO Randomized Controlled Trial [NCT02405130] | | 0 participants (Actual) | Interventional | 2015-04-30 | Withdrawn |
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] |
| Trial | Outcome |
|---|
| NCT00358579 (5) [back to overview] | Survival to Hospital Discharge. |
| NCT00358579 (5) [back to overview] | Survival to Admission. |
| NCT00358579 (5) [back to overview] | Return of Spontaneous Circulation. |
| NCT00358579 (5) [back to overview] | Neurological Status on Discharge or at 30 Days Post Arrest, if Not Discharged. |
| NCT00358579 (5) [back to overview] | Neurological Status at 1 Year. |
| NCT00562627 (3) [back to overview] | Opioid Use |
| NCT00562627 (3) [back to overview] | Pain at Rest (VAS) |
| NCT00562627 (3) [back to overview] | Time to Readiness for Discharge |
| NCT01143051 (16) [back to overview] | Number of Subjects With Significant Changes in Physical Examination |
| NCT01143051 (16) [back to overview] | Time to Reach Peak Concentration (Tmax) for Total Epinephrine |
| NCT01143051 (16) [back to overview] | Concentration vs. Time for Total Epinephrine From Time Zero to 6 Hours Post-dose |
| NCT01143051 (16) [back to overview] | ECG: QT Interval |
| NCT01143051 (16) [back to overview] | ECG: QTc Interval |
| NCT01143051 (16) [back to overview] | Hand Tremor Scores |
| NCT01143051 (16) [back to overview] | Serum Glucose Levels |
| NCT01143051 (16) [back to overview] | Peak Concentration (Cmax) for Total Epinephrine From Time Zero to 6 Hours Post-dose |
| NCT01143051 (16) [back to overview] | Serum Potassium Levels |
| NCT01143051 (16) [back to overview] | Vital Signs: Diastolic Blood Pressure (DBP) |
| NCT01143051 (16) [back to overview] | Vital Signs: Heart Rate (HR) |
| NCT01143051 (16) [back to overview] | Vital Signs: Systolic Blood Pressure (SBP) |
| NCT01143051 (16) [back to overview] | Area Under the Curve From Time Zero to 6 Hours Post-dose (AUC[0-6]) |
| NCT01143051 (16) [back to overview] | Baseline Concentration (C0) of Labeled Epinephrine Total Epinephrine |
| NCT01143051 (16) [back to overview] | Half-life (t1/2) for Total Epinephrine |
| NCT01143051 (16) [back to overview] | Number of Subjects With Significant Changes in Laboratory Tests |
| NCT01188577 (6) [back to overview] | Concentration vs. Time for Total Epinephrine From Time Zero to 6 Hours Post-dose |
| NCT01188577 (6) [back to overview] | Time to Reach Peak Concentration (Tmax) for Total Epinephrine |
| NCT01188577 (6) [back to overview] | Half-life (t1/2) of Total Epinephrine |
| NCT01188577 (6) [back to overview] | Baseline Concentration (C0) of Total Epinephrine |
| NCT01188577 (6) [back to overview] | Area Under the Curve From Time Zero to 6 Hours Post-dose (AUC[0-6]) for Total Epinephrine |
| NCT01188577 (6) [back to overview] | Peak Concentration (Cmax) of Total Epinephrine From Time Zero to 6 Hours Post-dose |
| NCT01243112 (2) [back to overview] | Onset of Action |
| NCT01243112 (2) [back to overview] | Length of Action |
| NCT01276821 (7) [back to overview] | Need for Unscheduled Medical Visits, if Any, for Same Symptoms to Any Healthcare Facility Within 1 Week |
| NCT01276821 (7) [back to overview] | Missed Days of Work of Caregivers |
| NCT01276821 (7) [back to overview] | Mean Change in Clinical Severity Score |
| NCT01276821 (7) [back to overview] | Average Duration of Crying (in Minutes) Among Babies Receiving Nebulisation Therapy. |
| NCT01276821 (7) [back to overview] | Patients Meeting Eligibility Criteria for ER/ OPD Discharge at the End of 2 Hours of Observation |
| NCT01276821 (7) [back to overview] | Persistence of Cough at the End of 1 Week |
| NCT01276821 (7) [back to overview] | Relapse Rate |
| NCT01602692 (7) [back to overview] | Anti-emetic / Intraoperative Medication Administered (mg) |
| NCT01602692 (7) [back to overview] | Amount of Post-Operative Narcotic Medication Administered |
| NCT01602692 (7) [back to overview] | Time to Discharge |
| NCT01602692 (7) [back to overview] | Anti-emetic / Intraoperative Fentanyl Administered (Measured in Micrograms) |
| NCT01602692 (7) [back to overview] | Unplanned Hospital Readmission |
| NCT01602692 (7) [back to overview] | Post Operative Nausea and Vomiting |
| NCT01602692 (7) [back to overview] | Post-operative Pain |
| NCT01706952 (4) [back to overview] | Blood Pressure |
| NCT01706952 (4) [back to overview] | End Tidal CO2 |
| NCT01706952 (4) [back to overview] | Heart Rate |
| NCT01706952 (4) [back to overview] | To Estimate the Change in Bleeding Category (Surgical Field Improvement) as Measured on a Six-point Scale, Measured From 0 (Best Case) to 5 (Worst Case). |
| NCT01862614 (1) [back to overview] | Number of Participants Achieving Pulpal Anesthesia. |
| NCT01966263 (3) [back to overview] | Timed Up and Go Test (TUG) |
| NCT01966263 (3) [back to overview] | Six Minute Walking Test (6MWT) |
| NCT01966263 (3) [back to overview] | Stair Climbing Task (SCT) |
| NCT01981772 (2) [back to overview] | Pain Measurement as Assessed on a Heft-Parker 170 mm Visual Analog Scale |
| NCT01981772 (2) [back to overview] | Postoperative Satisfaction on a 100 mm Visual Analog Scale |
| NCT02112370 (8) [back to overview] | Blood Loss Amount |
| NCT02112370 (8) [back to overview] | Maximum of Measured Diastolic Blood Pressures |
| NCT02112370 (8) [back to overview] | Maximum of Measured Systolic Blood Pressures |
| NCT02112370 (8) [back to overview] | Operation Time |
| NCT02112370 (8) [back to overview] | NRS Change |
| NCT02112370 (8) [back to overview] | NRS Pain Scores for the First 12 Hours |
| NCT02112370 (8) [back to overview] | Pain Killer Dose |
| NCT02112370 (8) [back to overview] | Maximum of Measured Heart Rates |
| NCT02299349 (2) [back to overview] | MS04 Equivalent Consumption |
| NCT02299349 (2) [back to overview] | Pain Scores (Visual Analog Pain Scores) |
| NCT02369510 (7) [back to overview] | Block Onset |
| NCT02369510 (7) [back to overview] | Motor Recovery |
| NCT02369510 (7) [back to overview] | Patient Satisfaction |
| NCT02369510 (7) [back to overview] | Sensory Recovery |
| NCT02369510 (7) [back to overview] | Incidence of Nausea and Vomiting |
| NCT02369510 (7) [back to overview] | Number of Participants With Hypotension |
| NCT02369510 (7) [back to overview] | Adequacy of Anesthesia |
| NCT02538679 (1) [back to overview] | Morphine Requirement |
| NCT02741713 (5) [back to overview] | Percentage of Participants With Episodes of Nausea or Vomiting |
| NCT02741713 (5) [back to overview] | Total Opioid Usage |
| NCT02741713 (5) [back to overview] | Time From Block Placement to Onset of Axillary Pain |
| NCT02741713 (5) [back to overview] | Post-operative Axillary Pain |
| NCT02741713 (5) [back to overview] | Numerical Rating Scale Pain Scores (0-10) at Rest |
| NCT03119181 (1) [back to overview] | Subject-reported Visual Analog Scale (VAS) Pain Score Following Tympanic Membrane Tap for Subjects Treated With Active Tymbion Iontophoresis Compared to VAS Score for Subjects Treated With Sham Tymbion Iontophoresis. |
| NCT03366298 (4) [back to overview] | Plasma Catecholamine Levels (Maximum Concentration, Area-under-curve (AUC)) |
| NCT03366298 (4) [back to overview] | Plasma Catecholamine Levels (Maximum Concentration, Cmax) |
| NCT03366298 (4) [back to overview] | Plasma Catecholamine Levels (Time to Maximum Concentration, Tmax) |
| NCT03366298 (4) [back to overview] | Adverse Events Following Self-administration of Adrenaline Via Autoinjector Device |
| NCT03562481 (4) [back to overview] | Mean Time to Lower Lip Numbness Following Injection |
| NCT03562481 (4) [back to overview] | Mean Time to Baseline Lip Sensation |
| NCT03562481 (4) [back to overview] | Mean Pain Scores Following Injection |
| NCT03562481 (4) [back to overview] | Average Serum Lidocaine Concentration at 15 Minutes Post Injection |
| NCT04207840 (6) [back to overview] | t[1/2], Terminal Elimination Half-life of Albuterol or Epinephrine |
| NCT04207840 (6) [back to overview] | C[Max], Maximum Plasma Concentration of Albuterol or Epinephrine |
| NCT04207840 (6) [back to overview] | AUC(0-tm)_TOT, Area Under the Curve (AUC) of Total (Exogenous and Endogenous, if Available) Active Product Ingredient (API) From Time 0 to Time (tm) |
| NCT04207840 (6) [back to overview] | AUC(0-tm)_DE, Area Under the Curve (AUC) of Exogenous Active Product Ingredient (API) From Time 0 to Time (tm) |
| NCT04207840 (6) [back to overview] | AUC(0-inf), Area Under the Curve (AUC) of Albuterol or Epinephrine From Time 0 to Infinity |
| NCT04207840 (6) [back to overview] | t[Max], Time at Which Maximum Plasma Concentration of Albuterol or Epinephrine is Observed |
| NCT05439460 (1) [back to overview] | Change in Systemic Vascular Resistance Index (SVRI) to Pulmonary Vascular Resistance Index (PVRI) Ratio (Rp:Rs Ratio) |
| NCT05867342 (7) [back to overview] | Surgical Field Grading Score |
| NCT05867342 (7) [back to overview] | Postoperative Bloody Discharge Grading Score |
| NCT05867342 (7) [back to overview] | Number of Extra Pledgets Used |
| NCT05867342 (7) [back to overview] | Number of Days With Postoperative Bloody Nasal Discharge |
| NCT05867342 (7) [back to overview] | Number of Nostrils With Continuous Fresh Bleeding |
| NCT05867342 (7) [back to overview] | Estimated Blood Loss During Surgery |
| NCT05867342 (7) [back to overview] | Duration of Surgery |
Survival to Hospital Discharge.
Survival to hospital discharge is defined as the patient leaving the hospital alive or survival to 30 days post cardiac arrest,whichever came first. This therefore measures the number of participants who was discharged alive or survived to 30 days post cardiac arrest, whichever came first. (NCT00358579)
Timeframe: at 30 days post arrest
| Intervention | Participants (Number) |
|---|
| Adrenaline | 8 |
| Vasopressin | 11 |
Survival to Admission.
Survival to admission is defined as the presence of pulse on admission to hospital (discharged from Emergency Department and admitted to Intensive Care Units /wards). This measures the number of participants with pulse and who were admitted to hospital. (NCT00358579)
Timeframe: No specific time frame. Survival to admission refers to sustained return of spontaneous circulation until admission and transfer of care to Intensive Care Units /wards
| Intervention | Participants (Number) |
|---|
| Adrenaline | 59 |
| Vasopressin | 83 |
Return of Spontaneous Circulation.
Return of spontaneous circulation is defined as the presence of any palpable pulse detected by manual palpation of a major artery. This is measured as number of participants who had return of spontaneous circulation during resuscitation. (NCT00358579)
Timeframe: during resuscitation
| Intervention | Participants (Number) |
|---|
| Adrenaline | 106 |
| Vasopressin | 119 |
Neurological Status on Discharge or at 30 Days Post Arrest, if Not Discharged.
Neurological status is assessed by the Glasgow-Pittsburgh outcome categories, to evaluate quality of life after successful resuscitation. Good neurological status is defined as cerebral performance categories(CPC)/overall performance categories(OPC):1 and 2.CPC/OPC 1 indicates good cerebral & overall performance. CPC/OPC 2 indicates moderate cerebral & overall disability. CPC/OPC 3 indicates severe cerebral & overall disability. CPC/OPC 4 indicates coma, vegetative state. CPC/OPC 5 indicates brain dead/death. (NCT00358579)
Timeframe: at 30 days post arrest
| Intervention | Participants (Number) |
|---|
| Cerebral Performance Categories 1 | Cerebral Performance Categories 2 | Overall Performance Categories 1 | Overall Performance Categories 2 |
|---|
| Adrenaline | 5 | 0 | 2 | 3 |
,| Vasopressin | 4 | 1 | 5 | 0 |
Neurological Status at 1 Year.
Neurological status is assessed by the Glasgow-Pittsburgh outcome categories, to evaluate quality of life after successful resuscitation. Good neurological status is defined as cerebral performance categories(CPC)/overall performance categories(OPC): 1 and 2. CPC/OPC 1 indicates good cerebral & overall performance. CPC/OPC 2 indicates moderate cerebral & overall disability. CPC/OPC 3 indicates severe cerebral & overall disability. CPC/OPC 4 indicates coma, vegetative state. CPC/OPC 5 indicates brain dead/death. (NCT00358579)
Timeframe: at 1 year post arrest
| Intervention | Participants (Number) |
|---|
| Cerebral Performance Categories 1 | Cerebral Performance Categories 2 | Overall Performance Categories 1 | Overall Performance Categories 2 |
|---|
| Adrenaline | 5 | 0 | 3 | 2 |
,| Vasopressin | 4 | 1 | 3 | 1 |
Opioid Use
Morphine used by patient controlled analgesia. Amount of used morphine during the first 48 hours after surgery were documented in the CRF by the pain nurses. (NCT00562627)
Timeframe: 48 hours postoperative
| Intervention | mg (Mean) |
|---|
| LIA IV (Local Infiltration Analgesia, Intravenous) | 77 |
| LIA IA, (Local Infiltration Analgesia, Intra-articular) | 49 |
| Epidural | 54 |
Pain at Rest (VAS)
VAS (pain at rest) 0-100 mm. VAS 0 mm means no pain and VAS 100 mm means maximal pain. (NCT00562627)
Timeframe: 48 hours postoperative
| Intervention | Units on a scale (Mean) |
|---|
| LIA IV (Local Infiltration Analgesia, Intravenous) | 18 |
| LIA IA, (Local Infiltration Analgesia, Intra-articular) | 12 |
| Epidural | 30 |
Time to Readiness for Discharge
Each postoperative day, discharge readiness was assessed by an orthopaedic surgeon, a pain nurse, a ward nurse, and a physiotherapist according to the following criteria: no evidence for surgical complications, VAS pain at rest ≤30 mm which is controlled by oral analgesics, ability to eat and drink, ability to walk with elbow crutches, and ability to climb ≥8 stairs. (NCT00562627)
Timeframe: up to 10 days postoperative
| Intervention | days (Mean) |
|---|
| LIA IV (Local Infiltration Analgesia, Intravenous) | 4 |
| LIA IA, (Local Infiltration Analgesia, Intra-articular) | 3.5 |
| Epidural | 5.5 |
Number of Subjects With Significant Changes in Physical Examination
Physical examinations were performed as a part of Screening and End-of-Study (EOS) procedures. This outcome is a count of the number of subjects that showed a clinically significant change in the EOS physical examination compared to the Screening Visit. (NCT01143051)
Timeframe: Approximately 6 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Randomized Subjects | 0 |
Time to Reach Peak Concentration (Tmax) for Total Epinephrine
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. tmax is the amount of time it takes for epinephrine to reach peak concentration in plasma during the treatment period. (NCT01143051)
Timeframe: Pre-dose to 6 hours post-dose
| Intervention | min (Mean) |
|---|
| Treatment T1 | 34.6 |
| Treatment T2 | 37.0 |
| Treatment C | 38.0 |
Concentration vs. Time for Total Epinephrine From Time Zero to 6 Hours Post-dose
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. (NCT01143051)
Timeframe: Pre-dose to 6 hours post-dose
| Intervention | pg/mL (Mean) |
|---|
| Total Epinephrine, 0 min (Baseline) | Total Epinephrine, 5 min post-dose | Total Epinephrine, 15 min post-dose | Total Epinephrine, 30 min post-dose | Total Epinephrine, 45 min post-dose | Total Epinephrine, 60 min post-dose | Total Epinephrine, 90 min post-dose | Total Epinephrine, 120 min post-dose | Total Epinephrine, 180 min post-dose | Total Epinephrine, 240 min post-dose | Total Epinephrine, 360 min post-dose |
|---|
| Treatment C | 7.8 | 130.2 | 38.5 | 16.8 | 20.9 | 18.0 | 16.7 | 13.1 | 8.4 | 9.8 | 38.3 |
,| Treatment T1 | 9.3 | 339.6 | 48.9 | 12.7 | 8.6 | 7.6 | 5.7 | 8.7 | 12.0 | 12.9 | 31.1 |
,| Treatment T2 | 8.9 | 442.4 | 62.4 | 17.4 | 13.0 | 14.5 | 13.7 | 15.5 | 10.4 | 11.5 | 29.4 |
ECG: QT Interval
Subject QT and QTc Intervals were recorded using a 12-Lead ECG prior to study drug dosing (baseline) and up to 360 minutes after dosing during the study visit. (NCT01143051)
Timeframe: Pre-dose (baseline) to 360 minutes post-dose
| Intervention | msec (Mean) |
|---|
| Pre-dose (Baseline) | 30 min post-dose | 90 min post-dose | 360 min post-dose |
|---|
| Treatment C | 423 | 413 | 407 | 400 |
,| Treatment T1 | 416 | 404 | 399 | 399 |
,| Treatment T2 | 407 | 405 | 401 | 400 |
ECG: QTc Interval
Subject QT and QTc Intervals were recorded using a 12-Lead ECG prior to study drug dosing (baseline) and up to 360 minutes after dosing during the study visit. (NCT01143051)
Timeframe: Pre-dose (baseline) to 360 minutes post-dose
| Intervention | msec (Mean) |
|---|
| Pre-dose (Baseline) | 30 min post-dose | 90 min post-dose | 360 min post-dose |
|---|
| Treatment C | 403 | 412 | 403 | 402 |
,| Treatment T1 | 407 | 408 | 401 | 403 |
,| Treatment T2 | 407 | 411 | 401 | 403 |
Hand Tremor Scores
Subjects evaluated hand tremor experiences using a scale from 0 to 3 (0: No tremor; 1: Mild, perceivable; 2: Moderate, observable; and 3: Severe, interfering with hand activities). Hand tremors were evaluated prior to study drug dosing (baseline) and up to 360 minutes post-dose. (NCT01143051)
Timeframe: Pre-dose (baseline) to 360 minutes post-dose
| Intervention | score on a scale (Mean) |
|---|
| Pre-dose (Baseline) | 10 min post-dose | 60 min post-dose | 360 min post-dose |
|---|
| Treatment C | 0.0 | 0.1 | 0.0 | 0.0 |
,| Treatment T1 | 0.0 | 0.1 | 0.0 | 0.0 |
,| Treatment T2 | 0.0 | 0.2 | 0.0 | 0.0 |
Serum Glucose Levels
Blood samples used to measure subject serum glucose and potassium levels were collected prior to study drug dosing (baseline) and up to 360 minutes post-dose. (NCT01143051)
Timeframe: Pre-dose (baseline) to 360 minutes post-dose
| Intervention | mg/dL (Mean) |
|---|
| Pre-dose (Baseline) | 15 min post-dose | 30 min post-dose | 60 min post-dose | 120 min post-dose | 360 min post-dose |
|---|
| Treatment C | 84 | 96 | 98 | 94 | 83 | 80 |
,| Treatment T1 | 83 | 101 | 94 | 86 | 81 | 82 |
,| Treatment T2 | 83 | 105 | 99 | 86 | 82 | 82 |
Peak Concentration (Cmax) for Total Epinephrine From Time Zero to 6 Hours Post-dose
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Peak (maximum) concentration (Cmax) is the highest concentration of epinephrine measured in plasma during the treatment period. (NCT01143051)
Timeframe: Pre-dose to 6 hours post-dose
| Intervention | pg/mL (Mean) |
|---|
| Treatment T1 | 340 |
| Treatment T2 | 444 |
| Treatment C | 139 |
Serum Potassium Levels
Blood samples used to measure subject serum glucose and potassium levels were collected prior to study drug dosing (baseline) and up to 360 minutes post-dose. (NCT01143051)
Timeframe: Pre-dose (baseline) to 360 minutes post-dose
| Intervention | mmol/L (Mean) |
|---|
| Pre-dose (Baseline) | 15 min post-dose | 30 min post-dose | 60 min post-dose | 120 min post-dose | 360 min post-dose |
|---|
| Treatment C | 4 | 4 | 4 | 4 | 4 | 4 |
,| Treatment T1 | 4 | 4 | 4 | 4 | 4 | 4 |
,| Treatment T2 | 4 | 4 | 4 | 4 | 4 | 4 |
Vital Signs: Diastolic Blood Pressure (DBP)
Subject vital signs, i.e., blood pressure and heart rate, were measured prior to study drug dosing (baseline) and up to 360 minutes after dosing during the study visit. (NCT01143051)
Timeframe: Pre-dose (baseline) to 360 minutes post-dose
| Intervention | mmHg (Mean) |
|---|
| Pre-dose (Baseline) | 10 min post-dose | 30 min post-dose | 60 min post-dose | 120 min post-dose | 180 min post-dose | 360 min post-dose |
|---|
| Treatment C | 61 | 65 | 65 | 63 | 62 | 59 | 62 |
,| Treatment T1 | 62 | 63 | 64 | 63 | 61 | 62 | 62 |
,| Treatment T2 | 61 | 64 | 64 | 64 | 63 | 60 | 62 |
Vital Signs: Heart Rate (HR)
Subject vital signs, i.e., blood pressure and heart rate, were measured prior to study drug dosing (baseline) and up to 360 minutes after dosing during the study visit. (NCT01143051)
Timeframe: Pre-dose (baseline) to 360 minutes post-dose
| Intervention | beats per minute (Mean) |
|---|
| Pre-dose (Baseline) | 10 min post-dose | 30 min post-dose | 60 min post-dose | 120 min post-dose | 180 min post-dose | 360 min post-dose |
|---|
| Treatment C | 58 | 62 | 61 | 61 | 58 | 63 | 61 |
,| Treatment T1 | 60 | 67 | 63 | 67 | 60 | 66 | 64 |
,| Treatment T2 | 62 | 69 | 64 | 67 | 60 | 66 | 64 |
Vital Signs: Systolic Blood Pressure (SBP)
Subject vital signs, i.e., blood pressure and heart rate, were measured prior to study drug dosing (baseline) and up to 360 minutes after dosing during the study visit. (NCT01143051)
Timeframe: Pre-dose (baseline) to 360 minutes post-dose
| Intervention | mmHg (Mean) |
|---|
| Pre-dose (Baseline) | 10 min post-dose | 30 min post-dose | 60 min post-dose | 120 min post-dose | 180 min post-dose | 360 min post-dose |
|---|
| Treatment C | 111 | 121 | 116 | 115 | 114 | 115 | 113 |
,| Treatment T1 | 110 | 123 | 116 | 113 | 112 | 114 | 113 |
,| Treatment T2 | 112 | 122 | 117 | 113 | 114 | 113 | 113 |
Area Under the Curve From Time Zero to 6 Hours Post-dose (AUC[0-6])
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Area under the curve from time zero to 6 hours post-dose (AUC[0-6]) was calculated using the trapezoidal rule. (NCT01143051)
Timeframe: Pre-dose to 6 hours post-dose
| Intervention | pg*min/mL (Mean) |
|---|
| Treatment T1 | 7938 |
| Treatment T2 | 9438 |
| Treatment C | 7218 |
Baseline Concentration (C0) of Labeled Epinephrine Total Epinephrine
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at Baseline (prior to dosing) in each treatment period following a specified washout period (3-14 days), and were analyzed using an established analysis method. Baseline concentration (C0) is the concentration of epinephrine measured in the plasma at this time point. (NCT01143051)
Timeframe: 0 to 30 minutes prior to dosing
| Intervention | pg/mL (Mean) |
|---|
| Treatment T1 | 9.3 |
| Treatment T2 | 8.9 |
| Treatment C | 7.8 |
Half-life (t1/2) for Total Epinephrine
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Half-life (t1/2) is the amount of time it takes for epinephrine decrease to half the peak concentration in plasma during the treatment period. (NCT01143051)
Timeframe: Pre-dose to 6 hours post-dose
| Intervention | min (Mean) |
|---|
| Treatment T1 | 125.9 |
| Treatment T2 | 158.8 |
| Treatment C | 237.3 |
Number of Subjects With Significant Changes in Laboratory Tests
Laboratory tests (CBC, serum comprehensive metabolic panel, urinalysis, and urinary pregnancy test for women of childbearing potential) were performed as a part of Screening and End-of-Study (EOS) procedures. This outcome is a count of the number of subjects that showed a clinically significant change in the EOS laboratory tests compared to the Screening Visit. (NCT01143051)
Timeframe: Approximately 6 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Randomized Subjects | 0 |
Concentration vs. Time for Total Epinephrine From Time Zero to 6 Hours Post-dose
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. (NCT01188577)
Timeframe: Pre-dose to 6 hours post-dose
| Intervention | pg/mL (Mean) |
|---|
| 0 min (Baseline) | 2 min post-dose | 5 min post-dose | 7.5 min post-dose | 10 min post-dose | 12.5 min post-dose | 15 min post-dose | 20 min post-dose | 25 min post-dose | 30 min post-dose | 45 min post-dose | 60 min post-dose | 90 min post-dose | 120 min post-dose | 240 min post-dose | 360 min post-dose |
|---|
| Treatment C | 4.3 | 189.0 | 99.1 | 48.8 | 39.7 | 33.9 | 32.0 | 30.1 | 20.3 | 17.7 | 19.8 | 13.2 | 11.2 | 6.9 | 17.7 | 17.2 |
,| Treatment T | 2.6 | 861.5 | 379.4 | 186.6 | 118.3 | 75.6 | 46.8 | 22.9 | 10.9 | 10.5 | 10.5 | 8.7 | 3.5 | 6.5 | 16.1 | 17.1 |
Time to Reach Peak Concentration (Tmax) for Total Epinephrine
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Tmax is the amount of time it takes for epinephrine to reach peak concentration in plasma during the treatment period. (NCT01188577)
Timeframe: Pre-dose to 6 hours post-dose
| Intervention | min (Mean) |
|---|
| Treatment T | 2.3 |
| Treatment C | 3.4 |
Half-life (t1/2) of Total Epinephrine
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Half-life (t1/2) is the amount of time it takes for epinephrine to decrease to half the peak concentration in plasma during the treatment period. (NCT01188577)
Timeframe: Pre-dose to 6 hours post-dose
| Intervention | min (Mean) |
|---|
| Treatment T | 145.9 |
| Treatment C | 289.8 |
Baseline Concentration (C0) of Total Epinephrine
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at Baseline (prior to dosing) in each treatment period following a specified washout period (3-14 days), and were analyzed using an established analysis method. Baseline concentration (C0) is the concentration of epinephrine measured in the plasma at this time point. (NCT01188577)
Timeframe: 0 to 30 minutes prior to dosing
| Intervention | pg/mL (Mean) |
|---|
| Treatment T | 2.6 |
| Treatment C | 4.3 |
Area Under the Curve From Time Zero to 6 Hours Post-dose (AUC[0-6]) for Total Epinephrine
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Area under the curve from time zero to 6 hours post-dose (AUC[0-6]) was calculated using the trapezoidal rule. (NCT01188577)
Timeframe: Pre-dose to 6 hours post-dose
| Intervention | pg*min/mL (Mean) |
|---|
| Treatment T | 8498 |
| Treatment C | 6191 |
Peak Concentration (Cmax) of Total Epinephrine From Time Zero to 6 Hours Post-dose
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Peak (maximum) concentration (Cmax) is the highest concentration of epinephrine measured in plasma during the treatment period. (NCT01188577)
Timeframe: Pre-dose to 6 hours post-dose
| Intervention | pg/mL (Mean) |
|---|
| Treatment T | 862 |
| Treatment C | 190 |
Onset of Action
Time from infusion of local anesthetic to loss of sensation to sharp. (NCT01243112)
Timeframe: Up to 5 minutes
| Intervention | second (Mean) |
|---|
| 1% Lidocaine With Epinephrine | 0.25% Bupivacaine With Epinephrine | 0.5% Lidocaine and 0.125% Bupivacaine With Epineph | 1% Lidocaine and 0.25% Bupivacaine With Epinephrin |
|---|
| Study Group | 29 | 19 | 26 | 12 |
Length of Action
The time from onset of local anesthesia until cessation of effect by sensation of sharp measured in 15 minute increments. (NCT01243112)
Timeframe: Up to 12 hours
| Intervention | minutes (Mean) |
|---|
| 1% Lidocaine With Epinephrine | 0.25% Bupivacaine With Epinephrine | 0.5% Lidocaine and 0.125% Bupivacaine With Epineph | 1% Lidocaine and 0.25% Bupivacaine With Epinephrin |
|---|
| Study Group | 6.63 | 7.02 | 7.48 | 7.16 |
Need for Unscheduled Medical Visits, if Any, for Same Symptoms to Any Healthcare Facility Within 1 Week
(NCT01276821)
Timeframe: 7 days
| Intervention | participants (Number) |
|---|
| Unscheduled medical Visits in 1 week | No Unscheduled medical visits in 1 week |
|---|
| Standard | 23 | 27 |
,| Study | 18 | 32 |
Missed Days of Work of Caregivers
Number of patients in each intervention group whose parents reported at least 1 day of missed work due to the illness of child within the week following the initial hospital visit on 7 day follow-up call. (NCT01276821)
Timeframe: 7 days
| Intervention | participants (Number) |
|---|
| Standard | 10 |
| Study | 3 |
Mean Change in Clinical Severity Score
"Mean changes in the Clinical Severity Score after 2 sessions of nebulisation as compared to baseline.~Clinical Severity Score devised by Wang et al, is an objective scoring system that measures the degree of respiratory distress in young children.~The scoring system assesses respiratory rate, wheezing, retraction, and general condition,scores ranging from 0 to 3, with higher scores indicating severe illness and vice versa.~The total scores range from 0 to 12, with increased severity receiving a higher score (Wang et al, 1992).~This scoring systems have previously been validated in a number of well designed randomized controlled trials(Anil 2010, Kuzik 2007, Sarrell 2002, and Mandelberg 2003). A 1 point improvement in the clinical severity score implies approximately 7% betterment of symptoms on the scale." (NCT01276821)
Timeframe: 2 hours
| Intervention | units on a scale (Mean) |
|---|
| Standard | 2.26 |
| Study | 3.57 |
Average Duration of Crying (in Minutes) Among Babies Receiving Nebulisation Therapy.
The outcomes tries to compare the influence of duration of crying among babies receiving nebulization which interferes with drug delivery and henceforth might create a confounding bias while interpreting results. (NCT01276821)
Timeframe: 2 hours
| Intervention | Minutes (Mean) |
|---|
| Standard | 2.16 |
| Study | 2.03 |
Patients Meeting Eligibility Criteria for ER/ OPD Discharge at the End of 2 Hours of Observation
(NCT01276821)
Timeframe: At the end of 2 hours
| Intervention | participants (Number) |
|---|
| Meets Criteria for ER/OPD discharge after 120 mins | Does not meet criteria for ER/OPD discharge |
|---|
| Standard | 15 | 35 |
,| Study | 35 | 15 |
Persistence of Cough at the End of 1 Week
Number of patients in each intervention group whose parents reported the persistence of initial cough at the end of 1 week in their children. (NCT01276821)
Timeframe: 7 days
| Intervention | participants (Number) |
|---|
| Persistence of cough at the end of 1 week | Absence of cough at the end of 1 week |
|---|
| Standard | 37 | 13 |
,| Study | 31 | 19 |
Relapse Rate
To study the number of patients in either group who need another unscheduled medical visit within the initial 24 hours of ER/ OPD visit (NCT01276821)
Timeframe: 24 hours
| Intervention | Participants (Number) |
|---|
| Hospital Re-visit within 24 hours | No Hospital Re-visit within 24 hours |
|---|
| Standard | 15 | 35 |
,| Study | 5 | 45 |
Anti-emetic / Intraoperative Medication Administered (mg)
The secondary outcomes that will be measured in this study include the amount of anti-emetic medication used in the first 24 hours post-op. This data will be attained by reviewing the medical record and through the validated survey questions. (NCT01602692)
Timeframe: Up to 24 hours following surgery
| Intervention | mg (Mean) |
|---|
| Mean Intraoperative hydromorphone | Mean Intraoperative midazolam | Mean Intraoperative ketorolac | Mean Intraoperative dexamethasone | Mean Intraoperative ondansetron |
|---|
| Tumescent Solution With Dilute Epinephrine | 0.98 | 2.00 | 11.25 | 6.40 | 3.60 |
,| Tumescent Solution With Dilute Lidocaine and Epinephrine | 1.06 | 1.90 | 16.50 | 6.00 | 4.05 |
Amount of Post-Operative Narcotic Medication Administered
Aim 1 is to determine the effect of dilute lidocaine in tumescent solution on post-operative pain following breast reduction surgery. The amount of narcotic medication administered (in Postanesthesia Care Unit (PACU), phase 2 and up to 24 hours post-op) determined by reviewing the medical record. (NCT01602692)
Timeframe: Up to 24 hours following surgery
| Intervention | mg (Mean) |
|---|
| PACU IV hydromorphone | First 24 hr Post-op oxycodone |
|---|
| Tumescent Solution With Dilute Epinephrine | 0.89 | 32.19 |
,| Tumescent Solution With Dilute Lidocaine and Epinephrine | 0.55 | 29.47 |
Time to Discharge
The patient's medical record will be reviewed to determine the time it took for the patient to be transitioned from the PACU (post anesthesia care unit) till discharge. This includes the time spent in the PACU, time spent in phase 2 and the total time to discharge. (NCT01602692)
Timeframe: Up to 24 hours following surgery
| Intervention | minutes (Mean) |
|---|
| Tumescent Solution With Dilute Epinephrine | 158 |
| Tumescent Solution With Dilute Lidocaine and Epinephrine | 153 |
Anti-emetic / Intraoperative Fentanyl Administered (Measured in Micrograms)
The secondary outcomes that will be measured in this study include the amount of anti-emetic medication used in the first 24 hours post-op. This data will be attained by reviewing the medical record and through the validated survey questions. (NCT01602692)
Timeframe: Up to 24 hours following surgery
| Intervention | micrograms (Mean) |
|---|
| Tumescent Solution With Dilute Epinephrine | 131.30 |
| Tumescent Solution With Dilute Lidocaine and Epinephrine | 120.00 |
Unplanned Hospital Readmission
The patient's medical record will be reviewed to see if the patient was readmitted to the hospital (unplanned) due to complications related to this surgery. (NCT01602692)
Timeframe: Up to 1 week following surgery
| Intervention | Participants (Count of Participants) |
|---|
| Tumescent Solution With Dilute Epinephrine | 0 |
| Tumescent Solution With Dilute Lidocaine and Epinephrine | 0 |
Post Operative Nausea and Vomiting
The secondary outcomes that will be measured in this study include number of episodes of post-operative nausea (subjective feeling vs. emesis). This data will be attained by reviewing the medical record and through the validated survey questions. (NCT01602692)
Timeframe: Up to 24 hours following surgery
| Intervention | episodes (Number) |
|---|
| Nausea | Vomiting |
|---|
| Tumescent Solution With Dilute Epinephrine | 8 | 2 |
,| Tumescent Solution With Dilute Lidocaine and Epinephrine | 10 | 4 |
Post-operative Pain
Aim 1 is to determine the effect of dilute lidocaine in tumescent solution on post-operative pain following breast reduction surgery. The data points that will be statistically compared will be pain scores determined via a validated pain survey (pain levels on a scale of 0-10 where 10 is the worst pain) and the amount of narcotic medication administered (in Postanesthesia Care Unit (PACU), phase 2 and up to 24 hours post-op) determined from responses to survey questions and by reviewing the medical record. (NCT01602692)
Timeframe: Up to 24 hours following surgery
| Intervention | score on a scale (Mean) |
|---|
| End of PACU Mean Pain Level | First 24 hrs Post-op Mean Current Pain | First 24 hrs Post-op Mean Worst Pain | First 24 hrs Post-op Mean Least Pain |
|---|
| Tumescent Solution With Dilute Epinephrine | 5.47 | 4.00 | 6.44 | 2.00 |
,| Tumescent Solution With Dilute Lidocaine and Epinephrine | 4.47 | 4.28 | 6.68 | 2.53 |
Blood Pressure
"The mean blood pressure, defined as the average arterial pressure during a single cardiac cycle, will be recorded every 15 minutes, until the surgery is over or until 300 minutes.~For the secondary objective of blood pressure, we calculated the mean within sides treated with cocaine vs adrenaline and assessed its difference" (NCT01706952)
Timeframe: Every 15 minutes or until 300 minutes
| Intervention | mmHg (Mean) |
|---|
| Cocaine SIDE | 68.02 |
| Adrenaline SIDE | 68.41 |
End Tidal CO2
"The concentration of carbon dioxide (CO2) in the respiratory gases will be recorded every 15 minutes or until 300 minutes.~For the secondary objective of concentration of carbon dioxide, we calculated the mean within sides treated with cocaine vs adrenaline and assessed its difference" (NCT01706952)
Timeframe: Every 15 minutes or until 300 minutes
| Intervention | Percentage of carbon dioxide (Mean) |
|---|
| Cocaine SIDE | 32.26 |
| Adrenaline SIDE | 31.69 |
Heart Rate
"The heart rate (heart beats for minutes) will be recorded every 15 minutes, until the surgery is over or until 300 minutes.~The Co-investigator will record this data in a special data sheeet For the secondary objective of Heart rate, we calculated the average within sides treated with cocaine vs adrenaline and assessed its difference" (NCT01706952)
Timeframe: Every 15 minutes until 300 minutes
| Intervention | Heart Beats per minute (Mean) |
|---|
| Cocaine SIDE | 74.68 |
| Adrenaline SIDE | 73.62 |
To Estimate the Change in Bleeding Category (Surgical Field Improvement) as Measured on a Six-point Scale, Measured From 0 (Best Case) to 5 (Worst Case).
"0 No bleeding.~Slight bleeding - no suctioning of blood required.~Slight bleeding - occasional suctioning required. Surgical field not threatened.~Slight bleeding - frequent suctioning required. Bleeding threatens surgical field a few seconds after suction is removed.~Moderate bleeding - frequent suctioning required. Bleeding threatens surgical field directly after suction is removed.~Severe bleeding - constant suctioning required. Bleeding appears faster than can be removed by suction. Surgical field severely threatened and surgery not possible.~For the primary objective of surgical field grade, we calculated the mean within sides treated with cocaine vs adrenaline and assessed its difference" (NCT01706952)
Timeframe: Every 15 minutes until 300 minutes
| Intervention | units on a scale (Mean) |
|---|
| Cocaine SIDE | 2.17 |
| Adrenaline SIDE | 2.04 |
Number of Participants Achieving Pulpal Anesthesia.
An electric pulp tester will be used to test the lower jaw teeth (molars, premolars, and incisors) for anesthesia (numbness) in 4-minute time cycles for 60 minutes. Measurements of less than 80 on the EPT is considered not numb (anesthesia failure). Readings of 80 equate to anesthetic success. (NCT01862614)
Timeframe: 60 minutes per injection sequence.
| Intervention | Participants (Count of Participants) |
|---|
| Articaine | 52 |
| Buffered Articaine | 57 |
Timed Up and Go Test (TUG)
"The TUG assesses basic mobility skill as well as strength, balance, and agility. Originally developed for frail elderly people as the Get-Up and Go Test in 1986, it was adapted in 1991 to include the time component. The TUG is used in a range of populations from children to the elderly and for many conditions, including osteoarthritis, joint arthroplasty, rheumatoid arthritis, hip fractures, stroke, vertigo, and cerebral palsy." (NCT01966263)
Timeframe: 1 year
| Intervention | seconds (Mean) |
|---|
| Local Infiltration Analgesia (LIA) | 7.8 |
| Femoral Nerve Block (FNB) | 7.6 |
Six Minute Walking Test (6MWT)
"The 6MWT assesses endurance and ability to walk over longer distances. The 6MWT was first described as a field test for physical fitness in 1963 and then as a 12-minute walk test in people with chronic bronchitis. The 6MWT was found to perform as well as the 12-minute walk, and is now used to assess the submaximal level of functional performance at a similar level required for daily physical activities.~Used in many conditions, such as osteoarthritis, cardiopulmonary disease, stroke, traumatic brain injury, patients who have undergone an amputation, Parkinson's disease, and Alzheimer's disease, as well as in elderly populations and children." (NCT01966263)
Timeframe: 1 year
| Intervention | meters (Mean) |
|---|
| Local Infiltration Analgesia (LIA) | 489 |
| Femoral Nerve Block (FNB) | 505 |
Stair Climbing Task (SCT)
The SCT assesses the ability to ascend and descend a flight of stairs, as well as lower extremity strength, power, and balance. (NCT01966263)
Timeframe: one year
| Intervention | seconds (Mean) |
|---|
| Local Infiltration Analgesia (LIA) | 14.3 |
| Femoral Nerve Block (FNB) | 13.8 |
Pain Measurement as Assessed on a Heft-Parker 170 mm Visual Analog Scale
"Patients will rate pain on a Heft-Parker visual analog scale during needle insertion, placement, and solution deposition phases of the anesthetic injection(s). Patients will also rate pain during the incision and dissection phases of the incision and drainage procedure. The number of millimeters along the scale are reported. No pain corresponded to 0 mm. Mild pain was defined as greater than 0 mm and less than or equal to 54 mm. Mild pain included the descriptors of faint, weak, and mild pain. Moderate pain was defined as greater than 54 mm and less than 114 mm and included the descriptor moderate. Severe pain was defined as equal to or greater than 114 mm up to and including 170 mm. Severe pain included the descriptors of strong, intense, and maximum possible." (NCT01981772)
Timeframe: during incision/drainage on Day 0
| Intervention | units on a scale (Mean) |
|---|
| Buffered Lidocaine | 69.3 |
| Nonbuffered Lidocaine | 59.2 |
Postoperative Satisfaction on a 100 mm Visual Analog Scale
"Patients will rate their level of satisfaction with the incision and drainage procedure using a visual analog scale. The scale ranges from not satisfied, to somewhat satisfied, to moderately satisfied, to completely satisfied. Not satisfied corresponded to 0 mm. Somewhat satisfied was defined as greater than 0 mm and less than or equal to 33 mm. Moderately satisfied was defined as greater than 33 mm and less than 66 mm. Completely satisfied was defined as equal to or greater than 66 mm. Measurements along the scale were collected and analyzed by randomization test." (NCT01981772)
Timeframe: immediately post-procedure on Day 0
| Intervention | units on a scale (Mean) |
|---|
| Buffered Lidocaine | 92.7 |
| Nonbuffered Lidocaine | 89.5 |
Blood Loss Amount
The blood loss amount is estimated at the end of surgery. (NCT02112370)
Timeframe: participants were followed for the duration of the operation, an average of approximately 2.5 hours
| Intervention | ml (Mean) |
|---|
| Normal Saline Injection | 30 |
| Ropivacaine With Epinephrine Injection | 18 |
Maximum of Measured Diastolic Blood Pressures
The maximal diastolic blood pressure is monitored during surgery. (NCT02112370)
Timeframe: participants were followed for the duration of the operation, an average of approximately 2.5 hours
| Intervention | mmHg (Mean) |
|---|
| Normal Saline Injection | 91 |
| Ropivacaine With Epinephrine Injection | 86 |
Maximum of Measured Systolic Blood Pressures
The maximal systolic blood pressure is monitored during surgery. (NCT02112370)
Timeframe: participants were followed for the duration of the operation, an average of approximately 2.5 hours
| Intervention | mmHg (Mean) |
|---|
| Normal Saline Injection | 142 |
| Ropivacaine With Epinephrine Injection | 145 |
Operation Time
The amount of time taken from start to the end of surgery (NCT02112370)
Timeframe: participants were followed for the duration of the operation, an average of approximately 2.5 hours
| Intervention | minutes (Mean) |
|---|
| Normal Saline Injection | 163.6 |
| Ropivacaine With Epinephrine Injection | 155.3 |
NRS Change
"Change in NRS score a with time The numerical rating scale is utilized to assess the postoperative pain change for the first 12 hours according to location.~Range: 0(minimal pain, better outcome) ~ 10(maximum pain, worse outcome)" (NCT02112370)
Timeframe: 0, 1, 2, 4, 6, 9, 12, 24, and 48 hours post operation
| Intervention | scores on a scale (Mean) |
|---|
| 0 hour | 1 hour | 2 hour | 4 hour | 6 hour | 9 hour | 12 hour | 24 hour | 48 hour |
|---|
| Normal Saline Injection | 5.73 | 5.05 | 4.55 | 3.55 | 3.39 | 3.28 | 3.19 | 2.93 | 2.27 |
,| Ropivacaine With Epinephrine Injection | 5.68 | 4.7 | 4.11 | 3.34 | 3.28 | 3.14 | 3.18 | 2.95 | 2.08 |
NRS Pain Scores for the First 12 Hours
"The numerical rating scale is utilized to assess the postoperative pain change for the first 12 hours according to location.~Range: 0(minimal pain, better outcome) ~ 10(maximum pain, worse outcome)~Unlike the general NRS pain score as reported in the post-operative 48 hour result which deals with post-operative discomfort in general, this outcome measures the pain score of the specific location in which flap dissection had taken place." (NCT02112370)
Timeframe: Postoperative 12 hours
| Intervention | points (Mean) |
|---|
| Swallowing difficulty | Anterior neck pain | Right chest pain | Left chest pain | Back pain | Posterior neck pain |
|---|
| Normal Saline Injection | 4.93 | 4.50 | 3.99 | 3.74 | 0.65 | 1.47 |
,| Ropivacaine With Epinephrine Injection | 4.12 | 3.69 | 3.16 | 4.51 | 0.28 | 1.65 |
Pain Killer Dose
Change in pain killer usage with time (NCT02112370)
Timeframe: 0, 1, 2, 4, 6, 9, 12, 24, and 48 hours post operation
| Intervention | vials (15mg ketorolac per vial) (Mean) |
|---|
| 0 hour | 1 hour | 2 hour | 4 hour | 6 hour | 9 hour | 12 hour | 24 hour | 48 hour |
|---|
| Normal Saline Injection | 1 | 0.35 | 0.31 | 0.07 | 0.18 | 0.14 | 0.18 | 0.20 | 0.01 |
,| Ropivacaine With Epinephrine Injection | 0.84 | 0.31 | 0.26 | 0.11 | 0.15 | 0.12 | 0.19 | 0.16 | 0.07 |
Maximum of Measured Heart Rates
The maximal heart rate is monitored during surgery. (NCT02112370)
Timeframe: participants were followed for the duration of the operation, an average of approximately 2.5 hours
| Intervention | beats per minute (Mean) |
|---|
| Normal Saline Injection | 88 |
| Ropivacaine With Epinephrine Injection | 99 |
MS04 Equivalent Consumption
in hospital total MS04 equivalent consumption (NCT02299349)
Timeframe: 1 day following surgery
| Intervention | mg (Median) |
|---|
| Bupivacaine Liposome Suspension | 10.0 |
| Concentrated Multi Drug Injection | 15.0 |
Pain Scores (Visual Analog Pain Scores)
visual analog pain scores (scale 0=no pain; 10=worst pain imaginable) (NCT02299349)
Timeframe: 1 day following surgery
| Intervention | units on a scale (Mean) |
|---|
| Bupivacaine Liposome Suspension | 2.6 |
| Concentrated Multi Drug Injection | 3.3 |
Block Onset
Time to a onset of T4 level of anesthesia or the highest level achieved in 15min (NCT02369510)
Timeframe: up to 15 min
| Intervention | minutes (Median) |
|---|
| Low-dose Epinephrine | 6 |
| High-dose Epinephrine | 8 |
| No Epinephrine | 8 |
Motor Recovery
Time to Bromage 3 motor recovery (NCT02369510)
Timeframe: up to 4 hours
| Intervention | minutes (Median) |
|---|
| Low-dose Epinephrine | 150 |
| High-dose Epinephrine | 172 |
| No Epinephrine | 120 |
Patient Satisfaction
"Patient satisfaction score was elicited upon arrival to the recovery room on a 1-5 Likert scale. Number of participants selecting the highest score of 5 or completely satisfied." (NCT02369510)
Timeframe: up to 3 hours
| Intervention | percentage of participants (Number) |
|---|
| Low-dose Epinephrine | 90 |
| High-dose Epinephrine | 85 |
| No Epinephrine | 87 |
Sensory Recovery
Time to T10 sensory recovery as measured by pinprick sensation (NCT02369510)
Timeframe: up to 3 hours
| Intervention | minutes (Median) |
|---|
| Low-dose Epinephrine | 135 |
| High-dose Epinephrine | 165 |
| No Epinephrine | 120 |
Incidence of Nausea and Vomiting
(NCT02369510)
Timeframe: up to 3 hours
| Intervention | Participants (Count of Participants) |
|---|
| 2 minutes | 25 minutes |
|---|
| High-dose Epinephrine | 0 | 6 |
,| Low-dose Epinephrine | 2 | 3 |
,| No Epinephrine | 4 | 1 |
Number of Participants With Hypotension
Incidence of hypotension as measured by participants needing vasopressor agents (NCT02369510)
Timeframe: at 2 minutes and at 25 minutes
| Intervention | Participants (Count of Participants) |
|---|
| 2 minutes | 25 minutes |
|---|
| High-dose Epinephrine | 2 | 9 |
,| Low-dose Epinephrine | 5 | 3 |
,| No Epinephrine | 8 | 3 |
Adequacy of Anesthesia
As measured by pinprick sensation and/or patient discomfort as measured by verbal pain score on a scale of 0=no pain to 10=worst imaginable pain, obtained within 3 hours of receiving anesthesia. (NCT02369510)
Timeframe: up to 3 hrs
| Intervention | units on a scale (Median) |
|---|
| Low-dose Epinephrine | 0 |
| High-dose Epinephrine | 0 |
| No Epinephrine | 0 |
Morphine Requirement
Compare ultrasound-guided block of the transversus abdominis plane (TAP) vs laparoscopic-guided TAP block, versus no TAP block on opioid consumption in the first 24 hours. Patients hospital chart was queried for use of any intravenous opioid in the first 24 hours after surgery including fentanyl or hydromorphone and conversion to morphine per standard opioid dose conversion. Total morphine equivalents then summed for the 24 hour postoperative period and compared between groups. (NCT02538679)
Timeframe: 24 hours
| Intervention | mg (Mean) |
|---|
| PLACEBO | 31.4 |
| US TAP Bupivacaine/Epinephrine | 39 |
| Lap TAP Bupivacaine/Epinephrine | 22.8 |
Percentage of Participants With Episodes of Nausea or Vomiting
Any episodes during the first 24 hours will be recorded as a yes. (NCT02741713)
Timeframe: Assessed 24hrs post-block (yes/no)
| Intervention | percentage of participants (Number) |
|---|
| Interscalene Block Plus Sham Block | 39 |
| Interscalene Plus PECS Blocks | 37 |
Total Opioid Usage
Recorded in oxycodone equivalents in the first 24 hours post-discharge from the PACU. (NCT02741713)
Timeframe: Assessed 24hrs post-block in mg
| Intervention | mg (Mean) |
|---|
| Interscalene Block Plus Sham Block | 31.6 |
| Interscalene Plus PECS Blocks | 26.9 |
Time From Block Placement to Onset of Axillary Pain
Time self-reported by patients in the Interscalene Plus PECS Blocks group during data collection phone call at 24 hours post-block. (NCT02741713)
Timeframe: Assessed 24hrs post-block in hours
| Intervention | Hours (Mean) |
|---|
| Interscalene Plus PECS Blocks | 16.7 |
Post-operative Axillary Pain
Post-operative ambulatory surgery subjects will be asked 6 hours after block placement about the presence of axillary pain at rest. Numerical Rating Scale scores (0-10) will be recorded with 0= no pain, 10=most pain possible. Higher scores denotes worse outcome. (NCT02741713)
Timeframe: 6 hours post-block.
| Intervention | units on a scale (Median) |
|---|
| Interscalene Block Plus Sham Block | 3 |
| Interscalene Plus PECS Blocks | 0 |
Numerical Rating Scale Pain Scores (0-10) at Rest
Subjects were asked about their overall shoulder pain during the followup phone call at 24hrs post-block. Numerical Rating Scale scores (0-10) will be recorded with 0= no pain, 10=most pain possible. Higher scores denotes worse outcome. (NCT02741713)
Timeframe: Assessed 24hrs post-block on a scale from 0-10.
| Intervention | units on a scale (Median) |
|---|
| Interscalene Block Plus Sham Block | 6 |
| Interscalene Plus PECS Blocks | 6 |
Subject-reported Visual Analog Scale (VAS) Pain Score Following Tympanic Membrane Tap for Subjects Treated With Active Tymbion Iontophoresis Compared to VAS Score for Subjects Treated With Sham Tymbion Iontophoresis.
"The VAS consists of a 100 millimeter (mm) line with a statement at each end representing the extreme limits of pain intensity (where 0 represents No pain and 100 represents The worst imaginable pain). The subject reports their pain intensity by making a mark along the line and the line is measured to convert the subject response to numeric score (0-100 in millimeters). The data will be summarized as the difference in mean VAS scores between the two treatment groups (active Tymbion iontophoresis compared to sham Tymbion iontophoresis)." (NCT03119181)
Timeframe: Day 0
| Intervention | millimeters (Mean) |
|---|
| Active Tymbion Iontophoresis | 4.2 |
| Sham Tymbion Iontophoresis | 18.3 |
Plasma Catecholamine Levels (Maximum Concentration, Area-under-curve (AUC))
"Pharmacokinetics (plasma catecholamine levels: AUC) following intramuscular self-injection of 300mcg and 500mcg adrenaline using an auto-injector device, in food-allergic teenagers over 40kg.~Baseline corrected." (NCT03366298)
Timeframe: At at the following timepoints following injection: 5, 10, 15, 20, 30, 45, 60, 80, 100, 120 and 180 minutes
| Intervention | hr*pg/ml (Mean) |
|---|
| Emerade 300mcg Injection | 174 |
| Emerade 500mcg Injection | 387 |
| Epipen 0.3mg | 203 |
Plasma Catecholamine Levels (Maximum Concentration, Cmax)
Pharmacokinetics (plasma catecholamine levels: Cmax) following intramuscular self-injection of 300mcg and 500mcg adrenaline using an auto-injector device, in food-allergic teenagers over 40kg. (NCT03366298)
Timeframe: 3 hours
| Intervention | pg/ml (Mean) |
|---|
| Emerade 300mcg Injection | 218 |
| Emerade 500mcg Injection | 394 |
| Epipen 0.3mg | 290 |
Plasma Catecholamine Levels (Time to Maximum Concentration, Tmax)
Pharmacokinetics (plasma catecholamine levels: Tmax) following intramuscular self-injection of 300mcg and 500mcg adrenaline using an auto-injector device, in food-allergic teenagers over 40kg. (NCT03366298)
Timeframe: 3 hours
| Intervention | minutes (Mean) |
|---|
| Emerade 300mcg Injection | 9.6 |
| Emerade 500mcg Injection | 8.5 |
| Epipen 0.3mg | 5.9 |
Adverse Events Following Self-administration of Adrenaline Via Autoinjector Device
Adverse events following self-administration of adrenaline via autoinjector device defined as in protocol (NCT03366298)
Timeframe: 1 day
| Intervention | Participants (Count of Participants) |
|---|
| Pain at injection site | Systemic AE (any) | Palpitations | Tremor |
|---|
| Emerade 300mcg Injection | 8 | 4 | 3 | 3 |
,| Emerade 500mcg Injection | 6 | 9 | 4 | 7 |
,| Epipen 0.3mg | 7 | 8 | 3 | 8 |
Mean Time to Lower Lip Numbness Following Injection
Time in minutes beginning immediately following injection to patient-reported lip numbness (NCT03562481)
Timeframe: Up to 30 minutes following injection
| Intervention | minutes (Mean) |
|---|
| Buffered Anesthetic | 3.4 |
| Unbuffered Anesthetic | 4.4 |
Mean Time to Baseline Lip Sensation
Response in minutes from injection to when lip is no longer numb, as self reported by patient. (NCT03562481)
Timeframe: Within 24 hours following injection
| Intervention | minutes (Mean) |
|---|
| Buffered Anesthetic | 218 |
| Unbuffered Anesthetic | 241 |
Mean Pain Scores Following Injection
"Perceived pain on injection, self-reported verbally using a Likert scale from 1-10, with lower numbers corresponding to less pain (1 = no pain, 10 = worst pain imaginable). Lower scores reflect a lesser degree of pain." (NCT03562481)
Timeframe: Within 10 minutes of injection
| Intervention | score on a scale (Mean) |
|---|
| Buffered Anesthetic | 3.0 |
| Unbuffered Anesthetic | 3.3 |
Average Serum Lidocaine Concentration at 15 Minutes Post Injection
Blood Lidocaine Level (mcg/mL) as measured in 10cc venous blood, taken 15 minutes following injection. Blood assayed for serum lidocaine levels with a Sciex TripleTOF liquid chromatography- mass spectrometry (LC-MS) equipped with a C18 Hypersil (10mm x 2.1mm, 3.0μm). (NCT03562481)
Timeframe: One blood draw taken 15 minutes following injection
| Intervention | mcg/ml (Mean) |
|---|
| Buffered Anesthetic | 243.5 |
| Unbuffered Anesthetic | 600.2 |
t[1/2], Terminal Elimination Half-life of Albuterol or Epinephrine
Pharmacokinetic (PK) blood samples will be collected starting 30 minutes before dose and until 24 hours after dose. Plasma will be isolated for analyzing the concentrations of Albuterol and Epinephrine. (NCT04207840)
Timeframe: Samples were drawn at 30 minutes pre-dose and at 1, 2, 3, 5, 7, 9, 12, 15, 18, 21, 25, 30, 40, 50, 60, 70, 80, 90, 120 minutes, 4, 6, 8, 12, 18, and 24 hours post-dose.
| Intervention | min (Geometric Mean) |
|---|
| Primatene Mist, E004 | 7.1 |
| Epinephrine Injection Auto-Injector (Generic of EpiPen) | 138.8 |
| Albuterol HFA | 420.7 |
C[Max], Maximum Plasma Concentration of Albuterol or Epinephrine
Pharmacokinetic (PK) blood samples will be collected starting 30 minutes before dose and until 24 hours after dose. Plasma will be isolated for analyzing the concentrations of Albuterol and Epinephrine. C[max] will be obtained directly from the plot of PK curve. (NCT04207840)
Timeframe: Samples were drawn at 30 minutes pre-dose and at 1, 2, 3, 5, 7, 9, 12, 15, 18, 21, 25, 30, 40, 50, 60, 70, 80, 90, 120 minutes, 4, 6, 8, 12, 18, and 24 hours post-dose.
| Intervention | pg/mL (Geometric Mean) |
|---|
| Primatene Mist, E004 | 240.8 |
| Epinephrine Injection Auto-Injector (Generic of EpiPen) | 704.8 |
| Albuterol HFA | 599.8 |
AUC(0-tm)_TOT, Area Under the Curve (AUC) of Total (Exogenous and Endogenous, if Available) Active Product Ingredient (API) From Time 0 to Time (tm)
Pharmacokinetic (PK) blood samples will be collected starting 30 minutes before dose and until 24 hours after dose. Plasma will be isolated for analyzing the concentrations of Albuterol and Epinephrine. AUC(0-tm)_TOT will be calculated with the trapezoid method. Time tm is defined as the time after C[max] is reached where API concentration is reduced to the levels of the same day baseline. (NCT04207840)
Timeframe: Samples were drawn at 30 minutes pre-dose and at 1, 2, 3, 5, 7, 9, 12, 15, 18, 21, 25, 30, 40, 50, 60, 70, 80, 90, 120 minutes, 4, 6, 8, 12, 18, and 24 hours post-dose.
| Intervention | pg/mL x hr (Geometric Mean) |
|---|
| Primatene Mist, E004 | 26.8 |
| Epinephrine Injection Auto-Injector (Generic of EpiPen) | 509.9 |
| Albuterol HFA | 3332.3 |
AUC(0-tm)_DE, Area Under the Curve (AUC) of Exogenous Active Product Ingredient (API) From Time 0 to Time (tm)
Pharmacokinetic (PK) blood samples will be collected starting 30 minutes before dose and until 24 hours after dose. Plasma will be isolated for analyzing the concentrations of Albuterol and Epinephrine. AUC(0-tm)_DE will be calculated with the trapezoid method. Time tm is defined as the time after C[max] is reached where API concentration is reduced to the levels of the same day baseline. (NCT04207840)
Timeframe: Samples were drawn at 30 minutes pre-dose and at 1, 2, 3, 5, 7, 9, 12, 15, 18, 21, 25, 30, 40, 50, 60, 70, 80, 90, 120 minutes, 4, 6, 8, 12, 18, and 24 hours post-dose.
| Intervention | pg/mL x hr (Geometric Mean) |
|---|
| Primatene Mist, E004 | 18.4 |
| Epinephrine Injection Auto-Injector (Generic of EpiPen) | 396.3 |
| Albuterol HFA | 3332.3 |
AUC(0-inf), Area Under the Curve (AUC) of Albuterol or Epinephrine From Time 0 to Infinity
Pharmacokinetic (PK) blood samples will be collected starting 30 minutes before dose and until 24 hours after dose. Plasma will be isolated for analyzing the concentrations of Albuterol and Epinephrine. AUC(0-inf) will be calculated with the extrapolation method. (NCT04207840)
Timeframe: Samples were drawn at 30 minutes pre-dose and at 1, 2, 3, 5, 7, 9, 12, 15, 18, 21, 25, 30, 40, 50, 60, 70, 80, 90, 120 minutes, 4, 6, 8, 12, 18, and 24 hours post-dose.
| Intervention | pg/mL x hr (Geometric Mean) |
|---|
| Primatene Mist, E004 | 18.4 |
| Epinephrine Injection Auto-Injector (Generic of EpiPen) | 411.4 |
| Albuterol HFA | 3650.4 |
t[Max], Time at Which Maximum Plasma Concentration of Albuterol or Epinephrine is Observed
Pharmacokinetic (PK) blood samples will be collected starting 30 minutes before dose and until 24 hours after dose. Plasma will be isolated for analyzing the concentrations of Albuterol and Epinephrine. t[max] will be obtained directly from the plot of PK curve when the maximum concentration is observed. (NCT04207840)
Timeframe: Samples were drawn at 30 minutes pre-dose and at 1, 2, 3, 5, 7, 9, 12, 15, 18, 21, 25, 30, 40, 50, 60, 70, 80, 90, 120 minutes, 4, 6, 8, 12, 18, and 24 hours post-dose.
| Intervention | min (Geometric Mean) |
|---|
| Primatene Mist, E004 | 2.6 |
| Epinephrine Injection Auto-Injector (Generic of EpiPen) | 8.3 |
| Albuterol HFA | 21.8 |
Change in Systemic Vascular Resistance Index (SVRI) to Pulmonary Vascular Resistance Index (PVRI) Ratio (Rp:Rs Ratio)
In patients with pulmonary hypertension (PH) one anticipates a greater increase in pulmonary vascular resistance as opposed to systemic vascular resistance when vasopressors are administered. (NCT05439460)
Timeframe: Day 1 (at baseline and up to 5 minutes following study drug administration) (Q: 2 minutes - 2 to 5 minutes?)
| Intervention | Rp:Rs ratio (Mean) |
|---|
| Baseline | Approx. 2 minutes following drug administration |
|---|
| Arginine Vasopressin | 0.75 | 0.49 |
,| Epinephrine | 0.61 | 0.6 |
,| Phenylephrine | 0.8 | 0.73 |
Surgical Field Grading Score
The video recording of the endoscopic sinus surgery of the participant was graded by another otolaryngology specialist postoperatively and graded according to Wormald Surgical Field Grading Scale. Scores range from 0 (no bleeding) to 10 (severe bleeding with nasal cavity filling rapidly). (NCT05867342)
Timeframe: postoperatively (approximately 20 minutes to assess)
| Intervention | score on a scale (Mean) |
|---|
| 1:1000 Epinephrine Plus Saline | 3.54 |
| 1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine | 3.23 |
Postoperative Bloody Discharge Grading Score
Grading of postoperative bloody discharge postoperatively assessed by patient using the 1-week postoperative bleeding questionnaire. Scores range from 0 (no bleeding) to 5 (continuous heavy bleeding necessitating medical care). (NCT05867342)
Timeframe: 1 week after the surgery (up to 2 minutes to complete assessment)
| Intervention | score on a scale (Mean) |
|---|
| 1:1000 Epinephrine Plus Saline | 2.38 |
| 1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine | 2.2 |
Number of Extra Pledgets Used
A pledget is a small wad of absorbent material used to stop bleeding. (NCT05867342)
Timeframe: intraoperatively (up to 3 hours)
| Intervention | pledgets (Mean) |
|---|
| 1:1000 Epinephrine Plus Saline | 3.25 |
| 1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine | 2.63 |
Number of Days With Postoperative Bloody Nasal Discharge
Participants indicated number of days with bloody nasal discharge postoperatively using the 1-week postoperative bleeding questionnaire. (NCT05867342)
Timeframe: 1 week after the surgery (up to 2 minutes to complete assessment)
| Intervention | days (Mean) |
|---|
| 1:1000 Epinephrine Plus Saline | 2.85 |
| 1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine | 2.73 |
Number of Nostrils With Continuous Fresh Bleeding
Number of nostrils with excessive fresh bleeding postoperatively using the 1-week postoperative bleeding questionnaire. Continuous fresh bleeding was defined as bleeding for over 15 minutes. (NCT05867342)
Timeframe: 1 week after the surgery (up to 2 minutes to complete assessment)
| Intervention | nostrils (Count of Units) |
|---|
| 1:1000 Epinephrine Plus Saline | 7 |
| 1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine | 5 |
Estimated Blood Loss During Surgery
(NCT05867342)
Timeframe: intraoperatively (up to 3 hours)
| Intervention | mL (Mean) |
|---|
| 1:1000 Epinephrine Plus Saline | 95.25 |
| 1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine | 91.63 |
Duration of Surgery
(NCT05867342)
Timeframe: intraoperatively (up to 3 hours)
| Intervention | minutes (Mean) |
|---|
| 1:1000 Epinephrine Plus Saline | 72.05 |
| 1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine | 54.23 |