Media Articles Related to Ryzolt (Tramadol)
FDA Reviewing Risk With Off-Label Tramadol Use in Children
Source: Medscape NeurologyHeadlines [2015.09.21]
The FDA is investigating the risk for respiratory problems in children aged 17 years and younger treated with the pain medication tramadol.
Inflammatory Back Pain Linked With Bone Loss (CME/CE)
Source: MedPageToday.com - medical news plus CME for physicians [2015.09.26]
(MedPage Today) -- Anti-TNF and NSAID therapies have protective effects
EMA Panel Backs Fentanyl Patch Ionsys for Acute Postop Pain
Source: Medscape Anesthesiology Headlines [2015.09.25]
Ionsys is a needle-free, patient-controlled, pre-programmed fentanyl delivery system for use in patients requiring short-term opioid analgesia after surgery.
Managing Pain in Patients With CVD
Source: Medscape Pharmacists Headlines [2015.09.25]
Are NSAIDs ever an option for pain management in patients with cardiovascular disease?
Medscape Internal Medicine
New drug trial could help relieve the pain of diabetes
Source: Clinical Trials / Drug Trials News From Medical News Today [2015.09.25]
UK patients with diabetic neuropathy are being recruited for a phase II clinical trial which will evaluate the safety, tolerability and efficacy of a novel class of analgesicThe trial will be...
Published Studies Related to Ryzolt (Tramadol)
Does the addition of tramadol and ketamine to ropivacaine prolong the axillary
brachial plexus block? 
ropivacaine in brachial plexus anesthesia... CONCLUSION: We conclude that when added to brachial plexus analgesia at a dose of
Efficacy of extended-release tramadol for treatment of prescription opioid
withdrawal: a two-phase randomized controlled trial. 
whether cessation of ER tramadol produces opioid withdrawal... CONCLUSIONS: ER tramadol 200mg modestly attenuated opioid withdrawal. Mild opioid
Comparison of the analgesic effects of oral tramadol and naproxen sodium on pain
relief during IUD insertion. 
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. 
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
on post tonsillectomy pain and compare the side effects... CONCLUSION: Preoperative peritonsillar infiltration of tramadol can decrease
Clinical Trials Related to Ryzolt (Tramadol)
Postoperative Tramadol/Gabapentin/Ibuprofen Versus Tramadol/Placebo/Ibuprofen [Recruiting]
Tonsillectomy is the most common pediatric surgical procedure performed in the US, with over
530,000 procedures performed annually in children under 15 years (Baugh et al., 2011). The
postoperative period can be particularly painful. A recent clinical consensus acknowledges
there is no standard analgesic protocol, and calls for further research comparing
postoperative pain medications (Baugh et al., 2011). Tramadol was found to be as effective
as codeine with few reported side effects in a recent double-blinded, controlled trial
conducted by the investigators at Children's Hospitals and Clinics (CHC), and it is
currently being prescribed in the postoperative setting. However, despite its effectiveness
for pain control, there were some children that continued to report pain during the 10-day
follow-up period. In response, the investigators will conduct a randomized, double-blinded
controlled trial to determine whether or not adding scheduled gabapentin to a scheduled
tramadol + "as needed" (PRN) ibuprofen regimen provides better pain control than tramadol +
ibuprofen PRN alone during the post-tonsillectomy period. 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 adding scheduled gabapentin to a postoperative
pain management protocol in a pediatric population.
A Comparison of Postoperative Tramadol Versus Acetaminophen With Codeine in Children Undergoing Tonsillectomy [Completed]
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.
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.
The Effect of Escitalopram on the Pharmacokinetics and Pharmacodynamics of Tramadol in Healthy Subjects [Completed]
Escitalopram will be given to a panel of 16 healthy subject for 9 days. On the ninth day a
single dose of tramadol is administered to the subjects and pharmacokinetic(PK) and
pharmacodynamic(PD) measurements are done for the next 24 hours.
It is stated that escitalopram is only a weak inhibitor of CYP2D6 and therefore no effect is
seen in Pk or PK of tramadol
A Dose Ranging Escalation Study of Tramadol Hydrochloride in Healthy Volunteers [Completed]
The purpose of this study is to determine the safety and tolerability profile of tramadol
hydrochloride (HCl) given as oral doses every 6 hours, within the range of dosages supported
by currently available toxicology and clinical data (200 mg to 600 mg per day).
CYTRAM (Cytochrome P450, Tramadol) [Completed]
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
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, Creteil 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.