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Tramadol and Acetaminophen (Tramadol Hydrochloride / Acetaminophen) - Summary

 
 



SUMMARY

Tramadol hydrochloride and acetaminophen tablets, 37.5 mg/325 mg, combines two analgesics, tramadol and acetaminophen.

Tramadol hydrochloride and acetaminophen tablets, 37.5 mg/325 mg, are indicated for the short-term (five days or less) management of acute pain.


See all Tramadol and Acetaminophen indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Tramadol and Acetaminophen (Tramadol / Acetaminophen)

Shrinking oral cancers with anti-pain agent spares healthy tissues
Source: Cancer / Oncology News From Medical News Today [2014.07.25]
Mouse models of human oral cancer treated with an agent called capsazepine showed dramatic tumor shrinkage without damage to surrounding tissues, researchers from the School of Dentistry and School...

Severe pain during and post delivery linked to postpartum depression
Source: Depression News From Medical News Today [2014.07.25]
Controlling pain during childbirth and post delivery may reduce the risk of postpartum depression, writes Katherine Wisner, M.D.

Research led by Temple's Chair of dermatology shows that pain and itch may be signs of skin cancer
Source: Medical Devices / Diagnostics News From Medical News Today [2014.07.25]
Asking patients if a suspicious skin lesion is painful or itchy may help doctors decide whether the spot is likely to be cancerous, according to a new study headed by Gil Yosipovitch, MD, Chairman...

FDA Approves Hard-to-Abuse Narcotic Painkiller
Source: MedicineNet Chronic Pain Specialty [2014.07.25]
Title: FDA Approves Hard-to-Abuse Narcotic Painkiller
Category: Health News
Created: 7/24/2014 12:36:00 PM
Last Editorial Review: 7/25/2014 12:00:00 AM

Health Tip: Easing Headache Pain
Source: MedicineNet Headache Specialty [2014.07.25]
Title: Health Tip: Easing Headache Pain
Category: Health News
Created: 7/25/2014 7:35:00 AM
Last Editorial Review: 7/25/2014 12:00:00 AM

more news >>

Published Studies Related to Tramadol and Acetaminophen (Tramadol / Acetaminophen)

Pharmacokinetics of extended-release versus conventional tramadol/acetaminophen fixed-dose combination tablets: an open-label, 2-treatment, multiple-dose, randomized-sequence crossover study in healthy korean male volunteers. [2011.06]
BACKGROUND: A fixed-dose combination tablet of tramadol/acetaminophen exhibits both rapid and sustained analgesic effects due to different pharmacologic activities. To prolong analgesia and improve patient convenience, an extended-release (ER) tablet of this agent has been developed. OBJECTIVE: The aim of this study was to explore the pharmacokinetic profiles of the new ER tramadol/acetaminophen fixed-dose combination and compare them with those of a conventional immediate-release (IR) formulation after multiple dosing as a Phase I clinical exploratory trial... CONCLUSIONS: The ER formulation displayed a similar AUC(0-12,ss) to that of the IR formulation for tramadol and acetaminophen. Copyright (c) 2011 Elsevier HS Journals, Inc. All rights reserved.

A single blind controlled comparison of tramadol/paracetamol combination and paracetamol in hand and foot surgery. A prospective study. [2011.03]
The objective of this study was to compare the efficacy and effectiveness between an analgesic combination of tramadol/paracetamol (37.5+325 mg), and paracetamol monotherapy (1000 mg) for acute postoperative pain after hand and foot surgery. The study design was a single blind randomized controlled trial...

Effects of clonidine as premedication on plasma renin activity, serum and urine electrolytes and body fluids in general anesthesia. A randomized double blind placebo controlled clinical trial. [2011.02]
CONCLUSION: This study suggested that clonidine is a safe premedication drug in anesthesia and does not change the serum electrolytes level.

Analgesia with paracetamol/tramadol vs. paracetamol/codeine in one day-surgery: a randomized open study. [2011.02]
OBJECTIVES: The analgesic efficacy of two fixed combinations of tramadol/paracetamol (TP 37.5/325 mg) and codeine/paracetamol (CP 30/500 mg) was compared in 122 patients undergoing one-day surgical procedures (hallux valgus, haemorrhoidectomy, varicectomy and inguinal hernia repair), randomly treated with TP 37.5/325 mg or CP 30/500 mg one tablet after surgery ended, followed by one tablet four times daily for 48 hours... CONCLUSIONS: We conclude that a fixed association of tramadol/paracetamol is a valuable and safe tool for pain management in day hospital surgery, especially whenever any effort is done to reduce the time for hospitalization.

The efficacy of intravenous paracetamol versus tramadol for postoperative analgesia after adenotonsillectomy in children. [2011.02]
STUDY OBJECTIVE: To evaluate the efficacy and the quality of recovery with intravenous (IV) paracetamol versus tramadol for postoperative analgesia after adenotonsillectomy in children... CONCLUSIONS: The IV formulation of paracetamol was associated with similar analgesic properties and early recovery to that of IV tramadol after adenotonsillectomy in children. Copyright (c) 2011 Elsevier Inc. All rights reserved.

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Clinical Trials Related to Tramadol and Acetaminophen (Tramadol / Acetaminophen)

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.

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.

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.

A One-Year, Open-Label Study to Assess the Safety and Effectiveness of Extended Release Tramadol HCl in the Treatment of Chronic, Non-Malignant Pain. [Completed]
The purpose of this study is to assess the safety of tramadol HCl ER following long-term treatment. The study hypothesis is that long-term treatment with tramadol HCl ER is safe and effective for the treatment of chronic, non-malignant pain.

more trials >>


Page last updated: 2014-07-25

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