NEWS HIGHLIGHTSMedia Articles Related to Ryzolt (Tramadol)
Erectile Dysfunction Tied To Long Term Painkiller Use
Source: Erectile Dysfunction / Premature Ejaculation News From Medical News Today [2013.05.16]
A new study suggests that long term use of opioid prescription painkillers for back pain is tied to a higher risk of erectile dysfunction (ED). The findings are published in the 15 May online issue of the journal Spine. Lead author Richard A...
Painkillers Increase Risk of Erectile Dysfunction
Source: Erectile Dysfunction / Premature Ejaculation News From Medical News Today [2013.05.15]
Regularly taking prescription painkillers, commonly called opioids, is linked to a greater risk of erectile dysfunction (ED) in men, according to a new study published in Spine. Over 11,000 men suffering from back pain were involved in the research...
Retooling Pain Assessment for Older Adults
Source: Medscape Emergency Medicine Headlines [2013.05.14]
Current pain assessment tools for older adults are inadequate, and education for healthcare professionals falls short in meeting the unique challenges posed by pain management for elderly patients.
Medscape Medical News
Tanezumab Makes Good in Chronic Back Pain (CME/CE)
Source: MedPage Today Neurology [2013.05.14]
NEW ORLEANS (MedPage Today) -- The controversial agent tanezumab, which was once put on an FDA regulatory hold, offered durable reduction of chronic low back pain, a long-term safety and efficacy study showed.
Persistent Pain After Sexual Assault Often Untreated
Source: Medscape Nurses Headlines [2013.05.13]
Although pain is common after sexual assault, more than 50% of women don't seek appropriate medical care 6 weeks after presenting to the ED.
Medscape Medical News
Published Studies Related to Ryzolt (Tramadol)
Comparison of the analgesic effects of oral tramadol and naproxen sodium on pain
relief during IUD insertion. [2012]
on pain during insertion of an intrauterine device (IUD)... CONCLUSION: Prophylactic analgesia using 50 mg tramadol and 550 mg naproxen,
Tramadol versus methadone for treatment of opiate withdrawal: a double-blind,
randomized, clinical trial. [2012]
The aim of this study was to compare the efficacy and safety of tramadol versus
methadone for treatment of opiate withdrawal. Seventy patients randomly were
assigned in two groups to receive either prescribed methadone (60 mg/day) or
tramadol (600 mg/day)... Tramadol may be as effective as methadone in the
control of withdrawal and could be considered as a potential substitute for
methadone to manage opioids withdrawal.
Comparison of peritonsillar infiltration effects of ketamine and tramadol on post
tonsillectomy pain: a double-blinded randomized placebo-controlled clinical
trial. [2012]
on post tonsillectomy pain and compare the side effects... CONCLUSION: Preoperative peritonsillar infiltration of tramadol can decrease
Evaluation of analgesic efficacy of intra-articular bupivacaine, bupivacaine plus fentanyl, and bupivacaine plus tramadol after arthroscopic knee surgery. [2011.12]
PURPOSE: To compare the efficacy of intra-articular (IA) bupivacaine, bupivacaine-fentanyl, and bupivacaine-tramadol for relief of postoperative pain after arthroscopic knee surgery... CONCLUSIONS: On the primary outcome measure (VAS pain score), both bupivacaine with fentanyl and bupivacaine with tramadol were better than IA bupivacaine, and bupivacaine with fentanyl was better than that with tramadol. However, both the combinations were comparable to each other with regard to the secondary outcome measure (supplementary analgesic requirement). Thus IA bupivacaine-fentanyl appears to be the best combination for relief of postoperative pain in patients undergoing arthroscopic knee surgery, followed by IA bupivacaine-tramadol. LEVEL OF EVIDENCE: Level I, randomized controlled trial. Copyright (c) 2011 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.
Wound Infiltration with Bupivacaine and Intramuscular Diclofenac Reduces Postoperative Tramadol Consumption in Patients Undergoing Radical Retropubic Prostatectomy: A Prospective, Double-blind, Placebo-controlled, Randomized Study. [2011.12]
OBJECTIVES: To assess the impact of wound infiltration with bupivacaine and i.m. diclofenac administration on patient-controlled analgesia (PCA) tramadol consumptions and postoperative pain in patients who underwent radical retropubic prostatectomy (RRP) under general anesthesia. Previous studies have found only limited or no benefits of local anesthetics for postoperative opioid consumption and pain relief after RRP... CONCLUSIONS: This prospective, double-blind, placebo-controlled, randomized study demonstrated that wound infiltration with bupivacaine during surgical closure combined with i.m. diclofenac administration might decrease in 24 hours with PCA tramadol consumption in patients who underwent RRP under general anesthesia. Copyright (c) 2011 Elsevier Inc. All rights reserved.
Clinical Trials Related to Ryzolt (Tramadol)
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, their
metabolites representing the most effective part of the drug effect. So prescribing codeine
or tramadol in a patient poor metabolizer for the CYP2D6 is likely to be ineffective in pain
management.
O-demethyl-tramadol, the metabolite of tramadol via CYP2D6, 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, 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, *4, *5 et *6) in a Caucasian population. 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, Créteil 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. 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, this method should be liked to improve pain
management. Furthermore, CYP2D6 phenotyping is interesting for the patient because many
other drugs depend on this way of metabolism.
A Comparison of Postoperative Tramadol Versus Acetaminophen With Codeine in Children Undergoing Tonsillectomy [Recruiting]
Tonsillectomy is the most common pediatric surgical procedure performed in the US. The
postoperative period can be particularly painful. Codeine (usually in mixed formulation with
acetaminophen) is the most commonly prescribed opioid in the US. However, evolving data
questions its ability to provide optimal pain relief, while avoiding side effects,
especially in the postoperative setting. Tramadol may be a better option for children in the
postoperative setting due to its well-documented analgesic properties, low potential for
side effects, and excellent safety profile. Seventy-two children scheduled to undergo
tonsillectomy (with or without adenoidectomy) at Children's will be invited to participate
in a randomized, prospective, double-blinded study to evaluate the efficacy and side effects
of codeine with acetaminophen versus tramadol. Using a 10-day take-home diary, caregivers
will be asked to record daily information about their child's postoperative pain and other
core outcomes and domains as recommended in the recent consensus statement put forth by the
Pediatric Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials
(IMMPACT) (McGrath et al., 2008). This study will offer new information regarding the
efficacy and side effects associated with tramadol as compared with codeine/acetaminophen
(the current practice standard) in a pediatric population.
Hypotheses
H1: Children who receive scheduled tramadol following tonsillectomy will report better pain
control than children who receive scheduled codeine/acetaminophen.
H2: Children who receive scheduled tramadol following tonsillectomy will report fewer side
effects than children who receive scheduled codeine/acetaminophen.
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. The second and third unit dose will be administered after 1 and 2 hours,
respectively, when a VAS of more than 3 is observed.
Tramadol Extended-Release (ER) for Posttraumatic Stress Disorder (PTSD) [Recruiting]
This is a six-week pilot study testing the efficacy of tramadol extended-release (ER) for
posttraumatic stress disorder (PTSD). Men and women aged 21-55 years with combat-related
PTSD (n=20) or PTSD resulting from a civilian trauma (n=20) will be recruited. Blinded
tramadol ER will begin with a 100 mg daily dose for the first week, with an option to
increase to 200 mg/day for the 2nd week. Dose adjustments, using a range of 100-300 mg
tramadol ER per day (or 1 to 3 placebo tabs), are permitted thereafter. The primary
hypothesis is that tramadol ER 100 to 300 mg every morning for 6 weeks will reduce the
symptoms of PTSD relative to placebo. The primary outcome measures will be PTSD symptoms as
rated by the Clinician-Administered PTSD Scale (CAPS) and Clinicians Global Impressions
scale at baseline and weeks one, two, four, and six. Assignment to blinded medication arms
will be stratified to ensure equivalence of the two arms (men and women, military and
civilian trauma).
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. 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. All subjects will
receive tramadol and duloxetine or tramadol and pregabalin in a randomized double-blind
order. Primary end point is O-desmethyltramadol concentration.
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