ORPHENADRINE SUMMARY
Orphenadrine citrate is the citrate salt of orphenadrine. It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly soluble in alcohol.
Orphenadrine citrate extended-release tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.
|
|
NEWS HIGHLIGHTS
Published Studies Related to Orphenadrine
Opiate sparing effect of fixed combination of diclophenac and orphenadrine after unilateral total hip arthroplasty: A double-blind, randomized, placebo-controlled, multi-centre clinical trial. [2010.11] Multimodal pain management combines analgesics to improve analgesia and reduce side effects... This study demonstrates that Neodolpasse((R)) Infusion Solution significantly reduces PCA analgesic requirements without compromising analgesic effectiveness and safety in THA patients.
Opiate sparing effect of fixed combination of diclophenac and orphenadrine after unilateral total hip arthroplasty: A double-blind, randomized, placebo-controlled, multi-centre clinical trial. [2010.10.08] Multimodal pain management combines analgesics to improve analgesia and reduce side effects... This study demonstrates that Neodolpasse((R)) Infusion Solution significantly reduces PCA analgesic requirements without compromising analgesic effectiveness and safety in THA patients.
Opiate sparing effect of fixed combination of diclophenac and orphenadrine after
unilateral total hip arthroplasty: A double-blind, randomized,
placebo-controlled, multi-centre clinical trial. [2010] Multimodal pain management combines analgesics to improve analgesia and reduce
side effects... This study demonstrates that
Neodolpasse(®) Infusion Solution significantly reduces PCA analgesic requirements
without compromising analgesic effectiveness and safety in THA patients.
[Diclofenac/orphenadrine as a combined analgetic in post-operative relief of pain] [2008.09.28] The authors compared the potency, safety and tolerability of combined infusion containing non-steroid anti-inflammation diclofenac and central muscle relaxant orphenadrine, and those of tramadol HCl, during postoperative pain relief after low and middle category operations... Based on all this, diclofenac-orphenadrine infusion is considered an effective and safe analgesic which is easy to administer and to combine in pain relief after small and middle category operations.
Comparison of the analgesic effects of a fixed-dose combination of orphenadrine and diclofenac (Neodolpasse) with its single active ingredients diclofenac and orphenadrine: a placebo-controlled study using laser-induced somatosensory-evoked potentials from capsaicin-induced hyperalgesic human skin. [2005] OBJECTIVE: The aim of this study was to investigate the analgesic efficacy of Neodolpasse, a fixed-dose combination of orphenadrine and diclofenac, compared with those of its single active ingredients in a human pain model... CONCLUSION: This study demonstrated the efficacy of Neodolpasse in a human pain model. The observed effect was mainly caused by central mechanisms and was found to be superior for the fixed-dose combination of orphenadrine and diclofenac compared with the individual ingredients. Both components contributed to the effect of the combination in an additive fashion, which can be explained by the different molecular mechanisms of action of each drug.
Clinical Trials Related to Orphenadrine
A Randomized Placebo Controlled Study of Orphenadrine` in the Treatment of Muscle Cramps in Patients With Cirrhosis [Recruiting]
Muscle cramps are common in patients with liver disease and associated with significantly
diminished quality of life. Patients with cirrhosis often experience muscle cramps with
varied frequency and severity. The exact mechanisms by which they occur remain unclear,
although a number of pathophysiological events unique to liver disease may contribute.
Clinical studies have identified alterations in 3 areas: nerve function, energy metabolism,
and plasma volume/electrolytes (1) Orphenadrine is an anticholinergic drug with prominent
central nervous system (CNS) and peripheral actions used to treat painful muscle spasms and
other similar conditions. The combination of anticholinergic effects and CNS penetration
make orphenadrine useful for pain of all etiologies, including from: radiculopathy, muscles,
and headaches. [3,4]
Intra-Venous Acetaminophen and Muscle Relaxants After Total Knee [Recruiting]
This is a prospective, three-arm, randomized, open-label trial to determine if a new pain
control protocol which includes regular dosing of intravenous acetaminophen and orphenadrine
for 48 hours after total knee surgery reduces the need for opioid pain medication and
reduces average pain scores.
The Analgesic Activity of a Topical Formulation in Patients With Osteoarthritis of the Hands [Not yet recruiting]
Osteoarthritis (OA) affects over 30 million people in the United States and represents our
nation's leading cause of disability. Data for the years between 1996-2005, indicate that
OA raised overall health care costs by $185. 5 billion annually. Largely as a consequence of
this disease, the number of patients undergoing joint replacement surgery will quadruple
over the next 17 years. Importantly, several recent studies have demonstrated that OA is an
independent risk factor for cardiovascular disease . Presently investigators have no
medications that alter the natural history of OA. Weight control, exercise and some
physical therapy measures are the only interventions short of total joint replacement that
alter the course of this disease. To make matters worse, investigators have experienced
only setbacks in use of medications aimed at symptom control. Recognition of toxicities of
non-steroidal anti-inflammatory drugs (NSAIDs) and narcotic-based analgesics has narrowed
the presently available armamentarium for pain control in OA . Clearly OA is a major factor
that demands better solutions as the health care system is redesigned.
OA involving the hands represents a major part of the overall burden of this disease. In
radiographic surveys about a quarter of the total US population has changes consistent with
OA involving the hands. Among the elderly, radiographic hand OA has been found in over half
of such individuals and as many as a quarter of them suffer from pain and functional
incapacitation. The joints affected typically are the first carpometacarpal (CMC-1) joint,
the distal interphalangeal (DIP) joints, and the proximal interphalangeal (PIP) joints .
Therapeutic options include acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs),
and a variety of physical measures such as physical therapy, bracing, and heat and cold
applications. To achieve some symptomatic benefit while limiting systemic toxicity, topical
therapies have been developed which either act as counter irritants, seek to reduce
substance P (capsaicin), or to deliver an NSAID locally through the skin. The leading
example of the latter is Diclofenac sodium gel which was shown to reduce pain intensity and
improve hand function in a double blind controlled trial. However none of these measures
have proven sufficiently effective to meet patient needs. Topical polytherapy will be
employed in this study to see if it will be effective against the pain of OA.
Patient Preferences, Analgesic Delivery Method and Pain Reduction in Spine Patients [Not yet recruiting]
The investigators will conduct a randomized double blind study, to determine whether patient
analgesic delivery mode preference affects pain reduction quality in non-surgical spine
patients.
The patients will receive both intra-muscular and oral non-narcotic analgesics and placebo.
During the study period, pain reduction parameters will be collected. At the end of the
study period, the investigators will attempt to find a correlation between pre-study patient
preferences and the quality of the pain reduction achieved.
Diclofenac Premedication, as the Effect of Preemptive Analgesia After Post-thoracotomy Chest and Shoulder Pain [Recruiting]
The purpose of the study is to examine if the hyposthesis of the preventive analgestic
characteristic of diclofenac given preoperatively has any effect on postoperative thoracic
wall and shoulder pain sensation. We also want to examine the rescue analgetic consumption
and the postoperative lung function test values.
|
|
Page last updated: 2013-02-10
|