Tramadol (Tramadol Hydrochloride) - Summary

TRAMADOL SUMMARY

TRAMADOL HYDROCHLORIDE TABLET
50 mg
Rx only

Tramadol hydrochloride tablet is a centrally acting analgesic.

Tramadol hydrochloride is indicated for the management of moderate to moderately severe pain in adults.

See all Tramadol indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Tramadol

NSAID Prescriptions for Pain 'Out of Control'
Source: Medscape Medical News Headlines [2013.06.15]
An increasing number of patients with heart disease and cardiovascular risk factors are prescribed nonsteroidal anti-inflammatory drugs rather than safer alternatives, warn researchers.
Medscape Medical News

EU regulator advises caution on painkiller diclofenac
Source: Yahoo! Health News [2013.06.14]
LONDON (Reuters) - Europe's drugs agency warned on Friday that use of the common painkiller diclofenac, especially in high doses, carries extra heart attack risks which should be taken into consideration by doctors prescribing the drug. While ...

Steroid Injections for Back Pain Linked to Spinal Fracture Risk
Source: MedicineNet Low Back Pain Specialty [2013.06.14]
Title: Steroid Injections for Back Pain Linked to Spinal Fracture Risk
Category: Health News
Created: 6/14/2013 10:35:00 AM
Last Editorial Review: 6/14/2013 12:00:00 AM

Cardiac MRI Use Reduces Adverse Events For Patients With Acute Chest Pain
Source: Cardiovascular / Cardiology News From Medical News Today [2013.06.13]
Wake Forest Baptist Medical Center doctors have found that using stress cardiac magnetic resonance (CMR) imaging in an Emergency Department observation unit to care for patients with acute chest pain is a win-win - for the patient and the institution. In a small, single-center clinical trial, Chadwick Miller, M.D., M.S...

Scant data on seizure drugs for women's genital pain
Source: Yahoo! Health News [2013.06.13]
By Kerry Grens NEW YORK (Reuters Health) - Although doctors sometimes prescribe anti-seizure drugs to treat chronic pain in the vulva, just a handful of low-quality studies have examined the drugs' effects, according to a new review. Based on ...

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Published Studies Related to 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 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. 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.

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.

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.

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.

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PATIENT REVIEWS / RATINGS / COMMENTS

Tramadol review by 44 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		Nerve Painn
Dosage & duration:		30mg but increased to 50mg taken once in the evenings for the period of 2years
Other conditions:		Required Hip to be resurfaced
Other drugs taken:		Endep, cortisone,
		Reported Results
Benefits:		The benefits allowed me to physically calm. this allowed me to sleep better, eat less and encourage a better outlook. Without Tramal life was very down.
Side effects:		Immediate sleepness, so needed to be careful when I took the tablet. Had to be careful if I took any other medications or alochol as there would be 'high' episodes.
Comments:		I only was required to take one tablet in the evenings, this was easy and I never forgot.

Tramadol review by 37 year old female patient
		Rating
Overall rating:
Effectiveness:		Marginally Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		Fibromyalgia Pain
Dosage & duration:		100 mg/day taken daily for the period of 6months
Other conditions:		hypothyroid, depression
Other drugs taken:		Effexor XR, Armour Thyroid
		Reported Results
Benefits:		In order to get any effects, I had to take 4-5 times the prescribed dosage. The medication is simply VERY WEAK. This drug did prove to me that managing pain on a daily basis, rather than responding to pain, significantly improved my quality of life and activity level.
Side effects:		I did not experience any side effects on a normal or high dose. A VERY HIGH dose (only taken accidentally, because I forgot I had taken my usual dose earlier) on an empty stomach, will produce an unpleasant "high" feeling mentally, including spaciness and shakiness. Therefore you can't just keep taking more and more of the drug.
Comments:		Bottom line, this drug just isn't very effective. It's more effective, and SIGNIFICANTLY SAFER, than the NSAIDS that docs are still prescribing for fibromylagia. But I am looking for better daily pain management.

Tramadol review by 53 year old female patient
		Rating
Overall rating:
Effectiveness:		Marginally Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		shoulder pain
Dosage & duration:		50 mg tablet, 1-2 tablets as needed taken every 6 hours for the period of 6 weeks
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		relief of pain
Side effects:		agitation, insomnia
Comments:		This drug was prescribed for pain caused by therapy for frozen shoulder. The pain was making it impossible to sleep at night, so the doctor prescribed tramadol. While the drug did moderate the pain, it also caused agitation, anxiety, insomnia. I stopped taking it after a few days. I also stopped the therapy. The pain went away and my shoulder improved on its own.