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Tham (Tromethamine) - Summary



Tham Solution (tromethamine injection) is a sterile, non-pyrogenic 0.3 M solution of tromethamine, adjusted to a pH of approximately 8.6 with glacial acetic acid. It is administered by intravenous injection, by addition to ACD blood for priming cardiac bypass equipment and by injection into the ventricular cavity during cardiac arrest. Each 100 mL contains tromethamine 3.6 g (30 mEq) in water for injection. The solution is hypertonic 389 mOsmol/L (calc.). pH 8.6 (8.4-8.7). The solution contains no bacteriostat, antimicrobial agent or added buffer (except acetic acid for pH adjustment) and is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. Tham solution is a parenteral systemic alkalizer and fluid replenisher.

Tham Solution (tromethamine injection) is indicated for the prevention and correction of metabolic acidosis. In the following conditions it may help to sustain vital functions and thus provide time for treatment of the primary disease:

  1. Metabolic Acidosis Associated with Cardiac Bypass Surgery.

    Tham Solution has been found to be primarily beneficial in correcting metabolic acidosis which may occur during or immediately following cardiac bypass surgical procedures.

  2. Correction of Acidity of ACD Blood in Cardiac Bypass Surgery.

    It is well known that ACD blood is acidic and becomes more acidic on storage. Tromethamine effectively corrects this acidity. Tham Solution may be added directly to the blood used to prime the pump-oxygenator. When ACD blood is brought to a normal pH range the patient is spared an initial acid load. Additional tromethamine may be indicated during cardiac bypass surgery should metabolic acidosis appear.

  3. Metabolic Acidosis Associated with Cardiac Arrest.

    Acidosis is nearly always one of the consequences of cardiac arrest and, in some instances, may even be a causative factor in arrest. It is important therefore, that the correction of acidosis should be started promptly with other resuscitative efforts. By correcting acidosis, Tham Solution (tromethamine injection) has caused the arrested heart to respond to resuscitative efforts after standard methods alone had failed. In these cases, tromethamine was given intraventricularly. It is to be noted, however, that such precariously ill patients often have died subsequently of causes unrelated to the administration of tromethamine. With administration by the peripheral venous route, metabolic acidosis has been corrected in a majority of patients. The success in reinstitution of cardiac rhythm by this means probably has not been of the same order of magnitude as with the intraventricular route.

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Published Studies Related to Tham (Tromethamine)

Ketorolac tromethamine: stereo-specific pharmacokinetics and single-dose use in postoperative infants aged 2-6 months. [2011.03]
OBJECTIVE: We determined the postoperative pharmacokinetics (PK), safety, and analgesic effects of ketorolac in 14 infants (aged <6 months) receiving a single intravenous (IV) administration of racemic ketorolac or placebo. BACKGROUND: Information on the PK of ketorolac in infants is limited. Unblinded studies suggest ketorolac may be useful in infants... CONCLUSION: Stereo-isomer-specific clearance of ketorolac in infants (aged 2-6 months) shows rapid elimination of the analgesic S (-) isomer as reported in infants aged 6-18 months. No adverse effects were seen after a single IV ketorolac dose. (c) 2010 Blackwell Publishing Ltd.

Ketorolac tromethamine LS 0.4% versus nepafenac 0.1% in patients having cataract surgery. Prospective randomized double-masked clinical trial. [2007.11]
PURPOSE: To compare the clinical, subjective, and objective outcomes of the use of 2 topical nonsteroidal antiinflammatory drugs--ketorolac tromethamine LS 0.4% (Acular) and nepafenac 0.1% (Nevanac)--in patients having cataract surgery. SETTING: Single-center private practice, Las Vegas, Nevada, USA... CONCLUSION: Ketorolac tromethamine was statistically significantly better than nepafenac in terms of patient satisfaction, compliance, and postoperative pain control.

Preoperative ketorolac tromethamine 0.4% in phacoemulsification outcomes: pharmacokinetic-response curve. [2006.09]
PURPOSE: To assess the clinical benefit, relative efficacy, and pharmacokinetic-response curve of preoperative and postoperative ketorolac tromethamine 0.4% (Acular LS) to improve outcomes during and after cataract surgery. SETTING: Private clinical practice... CONCLUSION: The preoperative use of ketorolac tromethamine 0.4% for 3 days followed by 1-day of predosing provided optimum efficacy and superior outcomes relative to 1-hour pretreatment and a placebo.

Evaluation of 0.4% ketorolac tromethamine ophthalmic solution versus 0.5% ketorolac tromethamine ophthalmic solution after phacoemulsification and intraocular lens implantation. [2006.08]
PURPOSE: The aim of this study was to compare the effectiveness and patient tolerance of 0.4% ketorolac tromethamine ophthalmic solution and 0.5% ketorolac tromethamine ophthalmic solution after routine phacoemulsification and lens implantation. Setting: The setting for this study was the Storm Eye Institute and Magill Research Center for Vision Correction, Medical University of South Carolina (Charleston, SC)... CONCLUSIONS: Treatment with 0.4% ketorolac tromethamine ophthalmic solution is as effective as 0.5% ketorolac tromethamine ophthalmic solution in reducing inflammation after routine cataract surgery. Patients reported less discomfort using 0.4% ketorolac.

Comparison of prednisolone 1%, rimexolone 1% and ketorolac tromethamine 0.5% after cataract extraction: a prospective, randomized, double-masked study. [2005.08]
PURPOSE: To compare the efficacy, safety and patient comfort of two topical steroids (prednisolone 1% and rimexolone 1%) and a topical non-steroidal anti-inflammatory agent (ketorolac tromethamine 0.5%) after extracapsular cataract extraction... CONCLUSIONS: Ketorolac tromethamine provides good control of intraocular inflammation after cataract extraction without the risk of a steroidal IOP increase, which was also not observed under rimexolone therapy. The best surface inflammation control and patient comfort was observed with prednisolone, which remains a good choice.

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Clinical Trials Related to Tham (Tromethamine)

The Effect of Thiazide, Amiloride and Hypertonic Saline on Urinary Biomarkers in Healthy Subjects [Not yet recruiting]
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Changes in the sodium-and water channel activity can be induced by blocking the sodium channels with diuretics in healthy subjects

Analgesic Effect of Different Combinations of Dexketoprofen Trometamol With Tramadol Hydrochloride in a Model of Moderate to Severe Pain [Recruiting]
The purpose of this study is to evaluate the analgesic efficacy of Dexketoprofen Trometamol and Tramadol Hydrochloride given in combinations and the analgesic efficacy of each single component in comparison to placebo on moderate to severe pain following impacted third mandibular molar tooth extraction. Ibuprofen will be used as an active control to validate the pain model.

Bevacizumab With or Without Fosbretabulin Tromethamine in Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cavity Cancer [Recruiting]
This randomized phase II trial is studying how well giving bevacizumab with or without fosbretabulin tromethamine works in treating patients with ovarian epithelial, fallopian tube, or peritoneal cavity cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab and fosbretabulin tromethamine may stop the growth of ovarian cancer by blocking blood flow to the tumor. It is not yet known whether bevacizumab is more effective when given together with fosbretabulin tromethamine in treating ovarian, fallopian tube, and peritoneal cavity cancer

Safety and Efficacy of Olopatadine Hydrochloride/Ketorolac Tromethamine Ophthalmic Solution Compared With Olopatadine Hydrochloride Ophthalmic Solution in Patients With Seasonal Allergic Conjunctivitis [Not yet recruiting]
This study will investigate the safety and efficacy of olopatadine hydrochloride / ketorolac tromethamine fixed dose combination ophthalmic solution compared with olopatadine hydrochloride ophthalmic solution in patients with seasonal allergic conjunctivitis.

Early Aggressive Correction of Severe Acidosis With Tris-hydroxymethylaminomethane (THAM) [Recruiting]
This study involved the medical record review of resuscitation records for all severely-injured trauma patients requiring emergent surgical intervention and significant acidosis from 2005 through 2009.

more trials >>

Page last updated: 2015-08-12

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