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Ultram ER (Tramadol Hydrochloride) - Summary

 
 



ULTRAM ER SUMMARY

ULTRAM® ER (tramadol hydrochloride) is a centrally acting synthetic analgesic in an extended-release formulation.

ULTRAM ER is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.


See all Ultram ER indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Ultram ER (Tramadol)

Post-op pain affects sleep, extends hospital stay
Source: Arthritis / Rheumatology News From Medical News Today [2014.09.26]
Pain can make it difficult for some patients to get a good night's rest while recovering in the hospital following certain surgical procedures, often resulting in longer hospital stays, according to...

DEA Makes Vicodin, Some Other Pain Meds Harder to Get
Source: MedPageToday.com - medical news plus CME for physicians [2014.09.26]
(MedPage Today) -- The agency is ratcheting up the restrictions on opioid painkillers another notch.

U.S. Pledges Millions to Study Ways to Ease Soldiers' Pain
Source: MedicineNet Alternative Medicine Specialty [2014.09.26]
Title: U.S. Pledges Millions to Study Ways to Ease Soldiers' Pain
Category: Health News
Created: 9/25/2014 12:36:00 PM
Last Editorial Review: 9/26/2014 12:00:00 AM

Common Painkillers Tied to Blood Clot Risk, Study Suggests
Source: MedicineNet Allergy Specialty [2014.09.25]
Title: Common Painkillers Tied to Blood Clot Risk, Study Suggests
Category: Health News
Created: 9/24/2014 7:36:00 PM
Last Editorial Review: 9/25/2014 12:00:00 AM

'Polyherbacy' a Common Challenge in Pain Patients
Source: Medscape NeurologyHeadlines [2014.09.23]
With chronic pain patients the leading drivers of the multi-billion-dollar dietary supplement industry, clinicians are put to the test to place things in perspective.
Medscape Medical News

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Published Studies Related to Ultram ER (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.

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Clinical Trials Related to Ultram ER (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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Reports of Suspected Ultram ER (Tramadol) Side Effects

Drug Ineffective (5)Hypersensitivity (3)Pruritus (3)Pain (3)Skin Burning Sensation (3)Myalgia (3)Hypersomnia (3)Arthralgia (3)Drug Dose Omission (2)Neck Pain (2)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 2 ratings/reviews, Ultram ER has an overall score of 5.50. The effectiveness score is 6 and the side effect score is 9. The scores are on ten point scale: 10 - best, 1 - worst.
 

Ultram ER review by 29 year old male patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   Cervical Disk Degeneration and Lower Back Pain
Dosage & duration:   50mg every 6 hrs as needed taken 2-3 times a day for the period of been taking for 2 weeks now.
Other conditions:   Tinitus, Unable to sleep
Other drugs taken:   Ambien
  
Reported Results
Benefits:   Ive been taking Tramadol for 2 weeks now. Ive been taking vicodin and percocuet for 7 months due to Cervial disk degeneration and lower back pain. I have to admit I loved taking Vicodin and percocuet. The problem is that they would knock me out. Tramadol has been awesome. It takes 90% of the pain away and I feel like I actually have energy again. From reading previous comments it sounds like I take a lower dose. Im really happy about that cause if I get use to it then I can up my dose and not feel worried about it.
Side effects:   I have had no side effects so far. I hope it stays that way.
Comments:   Treating for neck, shoulder, arms, lower back, hip, thigh and knee pain.

 

Ultram ER review by 34 year old female patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   Pain relief from an infected cat bite wound
Dosage & duration:   200mg taken once daily for the period of 2 days
Other conditions:   none
Other drugs taken:   Levaquin, Promethazine
  
Reported Results
Benefits:   I was not able to ascertain any benefits from being treated with this medication. Its purpose was pain relief, and I did not experience any alleviation of my pain.
Side effects:   I did not experience any side effects from taking this medication.
Comments:   I was prescribed this medication after being seen by a doctor for a severely infected cat bite wound on the top of my left foot (which the doctor was concerned might become a systemic infection). The foot and my entire left leg were very painful (especially upon movement), so the doctor had me take Ultram ER to help relieve the pain. I was told to take 1 tablet daily as needed. I did as instructed for two consecutive days and did not have any relief from my pain. After I reported this to my doctor, she gave me a prescription for a stronger pain reliever (which did help).

See all Ultram ER reviews / ratings >>

Page last updated: 2014-09-26

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