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There is a new group gathering political support for a say in the way the Drug Enforcement Administration runs the "war on drugs". Although there is no doubt of the need for firm action to reduce the availability of addictive drugs on the streets, the latest DEA crackdown does little more than penalize large numbers of ordinary people in pain. This April sees a Senate panel taking evidence from the owners and operators of nursing homes, doctors, nurse practitioners, and pharmacists. There is great concern at the new rules requiring pharmacies to wait for a prescription signed by a licensed doctor before dispensing the more powerful of painkillers,

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. In hospitals and nursing homes, the standard practice used to allow nursing staff to place orders for drugs orally, with the prescriptions being written up later. This smoothed the treatment regime,

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ensuring a continuous supply of medication without any delays caused by missing paperwork. That practice is now prohibited in nursing homes. Why should this matter? The answer lies in the numbers,

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. Nationally, there are about 16,000 nursing homes and they are literally "home" for some two million patients,

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. An average of about 60% of these people have problems with chronic pain. They are vulnerable. Many are old or confined to bed. They cannot fend for themselves by going to see a doctor and getting a prescription filled by a pharmacy. They depend on the medical staff to supply the drugs they need to manage the pain. In fact,

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many are left for days in acute pain without relief because the paperwork in the hands of the pharmacy does not match DEA requirements.

In fact, the DEA has stepped up enforcement with recent prosecutions in Ohio,

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, Michigan, Virginia and Wisconsin. This action is justified in two ways. First, there is a need to prevent the diversion of drugs from hospitals, clinics and nursing homes. If drugs are dispensed without paperwork, hospital staff could sell them on for street distribution. Secondly, some powerful meds are used by lazy nursing staff to dope any patient thought disruptive. This abuse of the vulnerable is made less likely if all dispensing is supervised by the attending physicians,

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. But strict enforcement ignores the reality of life in nursing homes,

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. Unlike hospitals, there are fewer doctors around and more day-to-day responsibility falls on the nursing practitioners. If nurses cannot be considered the agent of the supervising doctors, there can be serious delays in getting any prescription signed.

All systems are set up with checks and balances. In this case,

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, there are real problems to be addressed on both sides and it will be interesting to see where the Senate panel draws the line. If we were talking only about the less addictive painkillers like tramadol,

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there would be less cause to worry. Drugs which are not habit-forming should be made available with the minimum of formality within the nursing home environment,

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. This gives relief for the majority of people,

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. Where the level of pain goes beyond tramadol's limits, doctors should be more closely monitoring their patients' health. The balance of benefits and costs in the use of the more powerful drugs changes as people age and their health deteriorates. It might be reasonable to use the opiates for a person dying of cancer. Here,

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you want the maximum pain relief to make the person's last days more comfortable. In other cases,

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the use of stronger drugs should be careful monitored.

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Clinical Trials Related to Tramadol

A Comparison of the Effectiveness and Safety of ULTRACET® (Tramadol Hydrochloride/Acetaminophen) Versus ULTRAM® (Tramadol Hydrochloride) Versus Placebo in Patients With Pain After Oral Surgery [Completed]
The purpose of this study is to explore the pain-relieving effects and safety of two analgesic treatment regimens as compared to placebo in patients experiencing pain after oral surgery. Tramadol hydrochloride/acetaminophen is approved to treat acute pain,

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. This study will evaluate the effectiveness and safety of tramadol hydrochloride/acetaminophen compared with tramadol hydrochloride alone compared with placebo as a pain medication in the treatment of pain following oral surgery,

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.

CYTRAM (Cytochrome P450, Tramadol) [Recruiting]
Many methods to detect CYP2D6 poor metabolizers have been validated. Some of them are based on phenotyping (metabolism of dextromethorphan or debrisoquine) and some others on genotyping. Up to now, CYP2D6 pharmacogenetics has been restricted to the field of research, in spite of poor metabolizer profile concerns 5 to 10 % of caucasian population. Nevertheless, the polymorphism of CYP2D6 is responsible for the metabolism of many drugs, particularly of two opioids involved in pain management: codeine and tramadol,

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, their metabolites representing the most effective part of the drug effect,

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. So prescribing codeine or tramadol in a patient poor metabolizer for the CYP2D6 is likely to be ineffective in pain management,

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.

O-demethyl-tramadol, the metabolite of tramadol via CYP2D6,

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, is important to consider because its analgesic effect is 2 to 4 times more potent than tramadol.

The investigators propose to phenotype CYP2D6 in post-operative patients treated by tramadol by monitoring seric concentrations of O-demethyl tramadol and tramadol to make a ratio in comparison with genotype,

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, and to find a threshold to determine poor metabolizers. As already described, genotyping CYP2D6 will use a rapid detection method of the alleles implicated in poor metabolizer status (CYP2D6*3,

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,
*4, *5 et *6) in a Caucasian population,

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. Sampling will be executed at two times (H24 and H48 after surgery) and only with blood (three EDTA tubes) during the post-operative monitoring of the patients. This study is likely to include 320 post-operative patients treated with intravenous tramadol during one year in three university hospitals centers (CHU of Caen, CrГ©teil and Rouen).

The first aim of this study is the validation of monitoring seric concentrations of O-demethyl-tramadol and tramadol to make the ratio in order to detect CYP2D6 poor metabolizers in therapeutic situation, comparing the result with genotyping. The finding of a poor metabolizer status in a patient will make the choice of analgesic drugs easier, avoiding tramadol and codeine,

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. The final objective of this research is to be able to determine the CYP2D6 phenotype in a patient treated by tramadol without a good analgesia. By a single take of blood and a rapid response,

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,
this method should be liked to improve pain management. Furthermore,

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,
CYP2D6 phenotyping is interesting for the patient because many other drugs depend on this way of metabolism.

Comparison of Tramadol Orally Versus an Optimized Dose of Intravenous Tramadol for Postoperative Pain Relief in Ambulatory Surgery [Recruiting]
The purpose of this study is to compare the administration of 1 unit dose of 50 mg tramadol perorally given in 3 unit dosages versus tramadol IV given in 3 unit dosage of 35 mg during the first 6 hours postoperatively and to investigate the time course and accuracy of pain relief versus the onset and duration of side effects. The first unit dose will be administered at arrival at the PACU when a Visual Analogue Pain (VAS) score of more than 3 is reached,

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. The second and third unit dose will be administered after 1 and 2 hours, respectively, when a VAS of more than 3 is observed.

Efficacy, Safety, Tolerability and Pharmacokinetics of Concomitant Administration of Tramadol With Duloxetine or Pregabalin [Recruiting]
Tramadol is an opioid analgesic, which is widely used in the treatment of acute and neuropathic pain. Treatment of neuropathic pain often requires a combination of pain medications due to the complex nature of neuropathic pain and frequent inadequate response to drug treatment,

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. Common drugs used concomitantly with tramadol are SNRI antidepressant duloxetine and anticonvulsants such as pregabalin. Both tramadol and duloxetine have serotonergic effects and duloxetine has also a potential to inhibit metabolism of tramadol. The objective of the study is to investigate the pharmacokinetics and pharmacodynamic interaction of oral tramadol with duloxetine and pregabalin in patients with chronic neuropathic pain due to postherpetic neuralgia or diabetic polyneuropathy,

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. All subjects will receive tramadol and duloxetine or tramadol and pregabalin in a randomized double-blind order,

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. Primary end point is O-desmethyltramadol concentration,

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.

Celebrex vs Tramadol in the Treatment of Chronic Lower Back Pain. [Completed]
This study investigates if Celebrex is as effective as tramadol hydrochloride (Ultram) for patients with chronic low back pain, when administered over a 6-week period.




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