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Tramadol USE OF TRAMADOL IN PREGNANCY 0344 892 0909 USE OF TRAMADOL IN PREGNANCY (Date of issue: January 2016 , Version: 2 ) This is a UKTIS monograph for use by health care professionals. For case-specific advice please contact UKTIS on 0344 892 0909. To report an exposure please download and complete a . Please encourage all women to complete an . A corresponding patient information leaflet on is available at . Summary Tramadol is an opioid receptor agonist with serotonergic and noradrenergic (...) activity used in the management of moderate to severe pain. The available published data concerning gestational tramadol exposure describe the outcomes of approximately 1900 exposed infants, with the majority of the data considering the risk of congenital malformation alone. Data considering the risk of other adverse pregnancy outcomes are highly limited. Data regarding malformation risk are conflicting. A large prospective population-based study identified possible associations between first trimester
Tramadol for the management of pain in adult patients: clinical effectiveness and guidelines Tramadol for the management of pain in adult patients: clinical effectiveness and guidelines Tramadol for the management of pain in adult patients: clinical effectiveness and guidelines CADTH Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation CADTH (...) . Tramadol for the management of pain in adult patients: clinical effectiveness and guidelines. Ottawa: Canadian Agency for Drugs and Technologies in Health (CADTH). Rapid Response: reference list. 2014 Authors' conclusions Four systematic reviews, 17 randomized controlled trials, seven non-randomized studies, and five evidence-based guidelines were identified regarding the use of tramadol for the management of pain in adult patients. Final publication URL Indexing Status Subject indexing assigned by CRD
Efficacy of tramadol versus fentanyl for postoperative analgesia in neonates To assess, in newborn infants submitted to surgical procedures, the efficacy of two opioids-fentanyl and tramadol-regarding time to extubate, time to achieve 100 ml/kg of enteral feeding and pain in the first 72 h after surgery.Controlled, blind, randomised clinical trial.Neonatal intensive care unit.160 newborn infants up to 28 days of life requiring major or minor surgeries.Patients were randomised to receive (...) analgesia with fentanyl (1-2 μg/kg/h intravenously) or tramadol (0.1-0.2 mg/kg/h intravenously) in the first 72 h of the postoperative period, stratified by surgical size and by patient's gender.Pain assessed by validated neonatal scales (Crying, Requires oxygen, Increased vital signs, Expression and Sleepless Scale and the Neonatal Facial Coding System), time until extubation and time to reach 100 ml/kg enteral feeding. Statistical analysis included repeated measures analysis of variance adjusted
Antagonistic effects of ondansetron and tramadol? A randomized placebo and active drug controlled study Opposing effects of ondansetron and tramadol on the serotonin pathway have been suggested which possibly increase tramadol consumption and emesis when co-administered. In a randomized, double-blinded study, 179 patients received intravenous ondansetron, metoclopramide, or placebo for emesis prophylaxis. Analgesic regimen consisted of tramadol intraoperative loading and subsequent patient (...) -controlled analgesia. Tramadol consumption and response to antiemetic treatment were compared. Additionally, plasma concentrations of ondansetron and (+)O-demethyltramadol and CYP2D6 genetic variants were analyzed as possible confounders influencing analgesic and antiemetic efficacy. Tramadol consumption did not differ between the groups. Response rate to antiemetic prophylaxis was superior in patients receiving ondansetron (85.0%) compared with placebo (66.7%, P = .046), with no difference
Pain management after elective hallux valgus surgery: a prospective randomized double-blind study comparing etoricoxib and tramadol Pain is a common complaint after day surgery, and there is still a controversy surrounding the use of selective cyclooxygenase-2 (COX-2) inhibitors. In the present prospective, randomized, double-blind study we compared pain management with a selective (COX-2) inhibitor (etoricoxib) with pain management using sustained-release tramadol after elective hallux valgus (...) surgery.One hundred ASA 1 to 2 female patients were randomized into 2 groups of 50 patients each; oral etoricoxib 120 mg x 1 x IV + 90 mg x 1 x day V-VII and oral tramadol sustained-release 100 mg x 2 x VII. Pain, pain relief, satisfaction with pain management, and need for rescue medication were evaluated during the first 7 postoperative days. A computed tomography scan evaluating bone healing was performed 12 weeks after surgery. A clinical evaluation of outcome (healing, mobility, and patient-assessed
Postoperative pain management with tramadol after craniotomy: evaluation and cost analysis Patients undergoing craniotomies have traditionally received opiates with acetaminophen for the management of their postoperative pain. The use of narcotic pain medications can be costly, decrease rates of early postoperative ambulation, lengthen hospital stays, and alter a patient's neurological examination. The use of alternative pain medications such as tramadol may benefit patients by resolving many (...) of these issues.The authors conducted a randomized, blinded prospective study to evaluate the efficacy of alternative pain management strategies for patients following craniotomies. Fifty patients were randomly assigned either to a control group who received narcotics and acetaminophen alone or an experimental group who received tramadol in addition to narcotic pain medications (25 patients assigned to each group).The control group was noted to have statistically significant higher visual analog scale pain scores
Tramadol hydrochloride extended-release capsules Drug Approval Package: Tramadol NDA #022370 Drug Approval Package U.S. Food & Drug Administration Search FDA Drug Approval Package - Tramadol hydrochloride extended-release capsules 100 mg, 200 mg, and 300 mg Company: Cipher Pharmaceuticals, Inc. Application No.: 022370 Approval Date: 05/07/2010 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF
Adverse event profile of tramadol in recent clinical studies of chronic osteoarthritis pain Adverse event profile of tramadol in recent clinical studies of chronic osteoarthritis pain Adverse event profile of tramadol in recent clinical studies of chronic osteoarthritis pain Langley PC, Patkar AD, Boswell KA, Benson CJ, Schein JR CRD summary This review assessed the safety of long-acting formulations of tramadol hydrochloride in the treatment of chronic osteoarthritis pain and concluded (...) that differences in formulations may influence rates of adverse events. However, these differences should be interpreted with caution. Potential bias in the review, heterogeneity among studies and their unclear quality, support the authors' recommendation to interpret the findings with caution. Authors' objectives To assess the safety of various long-acting formulations of tramadol hydrochloride in the treatment of chronic osteoarthritis pain. Searching MEDLINE and EMBASE were searched between 1997 and 2008
Tramadol compared with opioids for pain: a review of addiction potential Tramadol compared with opioids for pain: a review of addiction potential Tramadol compared with opioids for pain: a review of addiction potential Pohar R, Cunningham J Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation Pohar R, Cunningham J. Tramadol compared (...) with opioids for pain: a review of addiction potential. Ottawa: Canadian Agency for Drugs and Technologies in Health (CADTH). 2010 Authors' conclusions Two RCTs were identified in which the abuse potential of tramadol was compared to another opioid analgesic. The results of one RCT were inconclusive given that no instances of abuse were identified. The other RCT suggested the abuse potential of tramadol was lower than hydrocodone-containing analgesics in patients with NCP and similar to that of NSAIDs
Tramadol hydrochloride - pain Common Drug Review CEDAC Meeting – March 19, 2008 Notice of CEDAC Final Recommendation – April 17, 2008 Page 1 of 2 CEDAC FINAL RECOMMENDATION and REASONS for RECOMMENDATION TRAMADOL HYDROCHLORIDE (Tridural ™ – Paladin Labs Inc.) Description: Tridural ™ is an extended release formulation of tramadol hydrochloride, a synthetic opioid analgesic. It is approved for the management of pain of moderate severity in adults who require treatment for several days or more (...) controlled trials (RCTs) of tramadol hydrochloride extended release tablets with other oral opiates available in Canada in the treatment of pain of at least several days duration in adults. No trials of Tridural ™ met the inclusion criteria for the systematic review. The Committee also reviewed the results of published systematic reviews of tramadol in chronic pain conditions which have reported that tramadol is more effective than placebo. These systematic reviews did not assess extended release
Tramadol hydrochloride /acetaminophen Common Drug Review CEDAC Meeting – April 18, 2007 Page 1 of 2 Notice of CEDAC Final Recommendation – May 17, 2007 CEDAC FINAL RECOMMENDATION and REASONS for RECOMMENDATION TRAMADOL HYDROCHLORIDE/ACETAMINOPHEN (Tramacet ™ – Janssen-Ortho Inc.) Description: Tramacet ™ is a fixed dose combination of tramadol hydrochloride, a synthetic opioid analgesic, and acetaminophen. It is approved for the short term (five days or less) management of acute pain. Dosage (...) Forms: Tablets contain 37.5 mg of tramadol hydrochloride and 325 mg of acetaminophen. The recommended dose of Tramacet ™ is one to two tablets every four to six hours, as needed, for pain relief, to a maximum of eight tablets per day. Recommendation: The Canadian Expert Drug Advisory Committee (CEDAC) recommends that Tramacet ™ not be listed. Reasons for the Recommendation: 1. There is insufficient evidence that Tramacet ™ provides a therapeutic advantage over less expensive analgesics
Tramadol for osteoarthritis. Tramadol is increasingly used for the treatment of osteoarthritis because, in contrast to nonsteroidal anti-inflammatory drugs (NSAIDs), tramadol does not produce gastrointestinal bleeding or renal problems, and does not affect articular cartilage.We sought to determine the analgesic effectiveness, the effect on physical function, the duration of benefit and the safety of oral tramadol in people with osteoarthritis.We searched the Cochrane Central Register (...) of Controlled Trials (CENTRAL), MEDLINE, EMBASE and LILACS databases up to August 2005.We included randomized controlled trials (RCTs) that evaluated the effect of tramadol or tramadol plus paracetamol on pain levels and/or physical function in people with osteoarthritis. No language restriction was applied.We analyzed separately placebo-controlled and active-controlled studies. We used fixed-effect models for the meta-analyses as the results across studies were similar.We included eleven RCTs with a total
Single-patient data meta-analysis of 3453 postoperative patients: oral tramadol versus placebo, codeine and combination analgesics Single-patient data meta-analysis of 3453 postoperative patients: oral tramadol versus placebo, codeine and combination analgesics Single-patient data meta-analysis of 3453 postoperative patients: oral tramadol versus placebo, codeine and combination analgesics Moore R A, McQuay H J Authors' objectives To assess the safety and effectiveness of oral tramadol (...) . Searching The trials were made available by Grunenthal GmbH (Aachen, Germany) and the Robert Wood Johnson Pharmaceutical Research Institute, (Pennsylvania, USA). In addition, the in-house database of Searle UK was searched, as were MEDLINE (from 1960 to 1995) and the Oxford Pain Relief Database (from 1950 to 1995)(see Other Publications of Related Interest no.1). 'Tramadol' was used as a free text term. Study selection Study designs of evaluations included in the review The review included individual