tramadol Ultram for pain

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tramadol Ultram for pain

Postby malernee » Sat Feb 26, 2005 12:30 pm

(for veterinary information only)

BRAND NAME: ULTRAM

AVAILABLE IN
50 mg
TABLETS

BACKGROUND:

The search for the relief of pain has existed for centuries if not millenia. It has long been known that the opiates are able to produce excellent analgesia as well as feelings of euphoria. Unfortunately, they are also habit forming, cause respiratory depression, sedation, and hallucinations. As science has examined the brain, several types of opiate receptors have been found such that stimulation of different receptors is responsible for the different effects of the opiates. For example, the “mu” and “delta” receptors account for analgesia (pain relief), euphoria, addiction, dropped heart rate and respiratory depression. The “kappa” receptors cause dysphoria (unpleasant feelings), constricted pupils, and sedation. The “sigma” receptors account for hallucinations. In the laboratory, it is possible to create opiates that stimulate only some receptors and not others. With delicacy it is possible to create a drug that creates analgesia and euphoria without being addictive or sedating. Tramadol represents such a drug.

In veterinary medicine there has been a recent explosion in the development of non-steroidal anti-inflammatory medications for the control of animal pain, particularly canine arthritis. These medications act by inhibiting cyclo-oxygenase, an enzyme that creates assorted inflammatory biochemicals. Unfortunately, cyclo-oxygenase also creates some much needed biochemicals as well and there are different forms of cyclo-oxygenase with different functions. These medications are virtually never safe for feline use (except in as one-time doses as in the control of pain associated with surgery). Further, occasionally, a dog will develop a reaction to one of the so-called COX-inhibiting anti-inflammatories. For these patients, a “mu” agonist like tramadol may be just the ticket.

HOW THIS MEDICATION IS USED:

Tramadol can be used for pain relief in both dogs and cats. (Most non-steroidal anti-inflammatory drugs are dangerous for feline use so this provides a nice choice for cats with chronic pain issues).

Tramadol is given two to three times daily.
SIDE EFFECTS:

If a pet develops apparent sedation or bizarre behavior, the tramadol dose should be reduced.

Upset stomach is occasionally observed with tramadol.

Side effects are generally considered rare.
INTERACTIONS WITH OTHER DRUGS:

The beauty of this pain reliever is that it is compatible with all the COX inhibiting non-steroidal anti-inflammatory drugs. It is also compatible with all the joint pain nutriceuticals such as glucosamine, MSM, etc.

Tramadol is NOT compatible with Deprenyl. Animals taking deprenyl either to control Cushing’s Syndrome or to control senility may not take any sort of narcotic agonist medication including tramadol. Similarly, tramadol is not compatible with other psychoactive drugs such as serotonin reuptake inhibitors, tricyclic antidepressants, or monoamine oxidase inhibitors. If you are not sure if your pet is on one of these medications, check with your veterinarian.

CONCERNS AND CAUTIONS:

Tramadol is not passed to nursing young and should be an acceptable pain reliever for a lactating mother.

A human product called “Ultracet®” is available. It contains acetaminophen in addition to tramadol. This product is NOT safe for use in pets.





Ultram & Dependency

Antinociception, tolerance, and physical dependence comparison between morphine and tramadol.

The mechanism of action of tramadol includes the activation of opioid receptors, and the potential ability of the drug to induce tolerance and physical dependence has been evaluated in different animal species and humans. This work was designed to study the involvement of opioid receptors in the antinociceptive activity and the potential ability to develop tolerance, crosstolerance, and/or physical dependence of tramadol. The writhes induced by acetic acid administration was used as algesiometric test.

After chronic administration of tramadol, tolerance was evaluated by measuring the antinociceptive activity, and physical dependence was measured by naloxone administration. Morphine was used as drug of comparison.

The i.p. administration of tramadol produced a dose-dependent antinociception with an ED50 value of 7.82 +/- 1.16 mg/kg, which was unchanged after chronic administration of either tramadol (39.1 or 100 mg/kg) or morphine (1.05 or 100 mg/kg). By contrast, the ED50 for morphine (0.21 +/- 0.08 mg/kg) was significantly reduced only by chronic pretreatment with both doses of morphine (tolerance).

Physical dependence was developed only in mice pretreated with morphine, as evidenced by the presence of jumps, wet-dog shakes, tachypnea, piloerection, seizures, diarrhea, and urination after the administration of naloxone (1 mg/kg).

These findings suggest that the antinociceptive activity of tramadol in mice is due to activation of opioid and nonopioid mechanisms, and as opposed to morphine, is not likely to induce tolerance and physical dependence.

Miranda HF, Pinardi G
Department of Pharmacology, Faculty of Medicine, Universidad de Chile, Santiago.
Pharmacol Biochem Behav 1998 Dec;61(4):357-60 [Medline record in process]



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Ultram & Acute Pain



[Patient-controlled analgesia. PCA in a three year old child after traumatic amputation].

We report the case of a 3-year-old boy, who received long-term parent-controlled analgesia after traumatic amputation of one leg. He underwent surgery 17 times for a period of 25 days. Parent-controlled analgesia was started four days after admission because analgesia with non-opioid analgetics (acetaminophen) proved to be insufficient. The pump was set to a bolus-dose of 23 micrograms kg-1 piritramide (dipidolor) and a lockout interval of 10 minutes. Permitted maximum cumulative dose in four hours was 5 mg piritramide. There was no continuous infusion of opioid. PCA and possible adverse effects were explained to the mother. A monitoring regimen was used to assess efficacy (pain intensity estimated by the mother), adverse effects (sedation score, occurrence of nausea and vomiting) and piritramide consumption. For fear of side effects opioid administration was insufficient in the beginning. After three days the mother used the PCA effectively and no additional analgesic medication was required. Nausea or other side effects were not observed. After seven days opioid consumption nearly doubled. Apart from tolerance, this might have resulted from the mother's caution in the first days. After 17 days the PCA was discontinued. Oral analgetics (tramadol) controlled the pain adequately. Management of postoperative pain in children is difficult and too often insufficient. PCA is a safe and effective method of providing postoperative pain relief. Feasibility was shown in adolescents and, more recently, in children aged five years and over. Only few reports are available describing long term use of PCA in children younger than five years. Our case suggests that PCA may also be used effectively and safely in children younger than five years, if experienced staff, a monitoring regimen and cooperative and well instructed parents are available.

Kerschbaum G, Altmeppen J, Funk W, Taeger K
Klinik fur Anasthesiologie, Klinikum der Universitat Regensburg.
Anaesthesist 1998 Mar;47(3):238-42 [Article in German]



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Tramadol in the treatment of postanesthetic shivering.

BACKGROUND: As an inhibitor of the reuptake of serotonin and norepinephrine in the spinal cord, the mechanism of action of tramadol resembles that of nefopam, which has been used in the treatment of postanesthetic shivering.

METHODS: In a randomized, placebo-controlled, double-blind study, we assessed the effects of tramadol (0.5 mg.kg-1, 1 mg.kg-1 and 2 mg.kg-1 i.v.) or normal saline on shivering after a standardized general anesthesia in 40 adult patients, ASA physical status I or II (group 1), and in 64 adult patients regardless of the foregoing general anesthesia and ASA physical status (group 2).

RESULTS: Tramadol 1 mg.kg-1 or more abolished shivering completely 5 min after treatment in all patients of groups 1 and 2. In group 1, the three dosages of tramadol were not statistically different in lowering the severity and prevalence of postanesthetic shivering. Tramadol 0.5 mg.kg-1 was significantly slower than tramadol 1 or 2 mg.kg-1 in tempering the severity as well as lowering the prevalence of postanesthetic shivering in group 2.

CONCLUSION: Tramadol's distinct features in the treatment of shivering reside in its high safety profile and weak sedative properties, particularly in patients with poor cardiorespiratory reserve, in outpatients and on recurrence of shivering.

de Witte J, Deloof T, de Veylder J, Housmans PR
Department of Anesthesiology and Critical Care Medicine, OLV-Clinic, Aalst, Belgium.
Acta Anaesthesiol Scand 1997 Apr;41(4):506-10
Publication Types: Clinical trial; Randomized controlled trial



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Analgesia after day case laparoscopic sterilisation. A comparison of tramadol with paracetamol/dextropropoxyphene and paracetamol/codeine combinations.

In a prospective, double-blind trial we compared the analgesic efficacy of tramadol during the first 24 h after day case laparoscopic sterilisation with two commonly prescribed combination analgesics. Seventy-five women were allocated randomly to receive oral paracetamol 325 mg/dextropropoxyphene hydrochloride 32.5 mg, tramadol 50 mg or paracetamol 500 mg/codeine phosphate 30 mg as required after a standardised anaesthetic technique. There were no significant differences in average or worst pain, sleep disturbance, mobility, number of tablets taken, satisfaction or preference for stronger analgesia (26.2% of all patients). The incidences of nausea and vomiting were comparable between groups. There was a trend towards a lower incidence of central nervous system side-effects (drowsiness, dizziness, headache) in the paracetamol/codeine group. Tramadol may be considered an alternative analgesic for day case surgery although analgesic regimens of greater efficacy are required for many patients. The relative incidence of side-effects for tramadol and other analgesics requires further evaluation.

Crighton IM, Hobbs GJ, Wrench IJ
University Department of Anaesthesia, Queen's Medical Centre, Nottingham, UK.
Anaesthesia 1997 Jul;52(7):649-52
Publication Types: Clinical trial; Randomized controlled trial



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Comparison of tramadol and tramadol/droperidol mixture for patient-controlled analgesia.

PURPOSE: To compare the analgesic efficacy and side effects of tramadol vs tramadol and droperidol for post-operative patient-controlled analgesia (PCA).

METHODS: Randomised, double-blind study. Thirty-four patients undergoing elective colorectal or head and neck surgery were allocated to Group 1 (n = 18, PCA bolus 10 mg tramadol) or Group 2 (n = 16, PCA bolus 10 mg tramadol + 0.1 mg droperidol). Anaesthesia was induced with fentanyl and thiopentone and maintained with O2, N2O plus enflurane or isoflurane with iv morphine at doses decided by the attending anaesthetists. Muscle relaxation was achieved with atracurium or vecuronium. Patients were observed four-hourly for pain using an 11-point verbal rating scale (VRS). Nausea and vomiting, and sedation were assessed using four-point scales post-operatively. Vital signs, request for rescue anti-emetic and analgesic, and overall satisfaction were recorded.

RESULTS: The mean nausea scores were lower in Group 2 (1.00 +/- 1.33 vs 0.06 +/- 0.25 at 0-8 hr, 1.22 +/- 1.93 vs 0.06 +/- 0.25 at 8-16 hr, P < 0.01; 0.81 +/- 1.68 vs 0 at 32-40 hr, P < 0.05; Group 1 vs Group 2). The vomiting scores were also lower (0.50 +/- 1.04 vs 0 at 0-8 hr, 0.67 +/- 1.50 vs 0, at 8-16 hr, P < 0.05; Group 1 vs Group 2). Seven (39%) patients in Group 1, but none in Group 2 requested rescue anti-emetic (P < 0.01). There were no differences in VRS, sedation score, overall satisfaction or vital signs.

CONCLUSION: Tramadol and droperidol combination is superior to tramadol alone for post-operative PCA. It provides a similar quality of analgesia with less nausea and vomiting and without an increase in sedation.

Ng KF, Tsui SL, Yang JC, Ho ET
Department of Anaesthesiology, University of Hongkong, Hongkong. jkfng@hkucc.hku.hk
Can J Anaesth 1997 Aug;44(8):810-5
Publication Types: Clinical trial; Randomized controlled trial



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Acute pain management: operative or medical procedures and trauma.

OBJECTIVE: To review the topics presented in the Agency for Health Care Policy and Research (AHCPR) Clinical Practice Guideline for Acute Pain Management and provide updated information on therapeutic issues as necessary.

DATA SOURCES: AHCPR Clinical Practice Guideline for Acute Pain Management: Operative or Medical Procedures and Trauma. A MEDLINE search (1990 to June 1996) of English-language literature pertaining to pain assessment and management was performed. Reference lists from relevant articles also served as a literature source.

STUDY SELECTION AND DATA EXTRACTION: All articles identified from the data sources were evaluated. Relevant information, as determined by the authors, was included in the review.

DATA SYNTHESIS: Inadequate acute pain management continues to be recognized as a problem due to limited health professional education on the treatment of pain, inadequate patient empowerment, negative connotations associated with opioid analgesics (e.g., fear of "addiction"), federal regulations associated with prescribing opioid analgesics, and difficulty in assessing pain. The widespread inadequacy in pain management prompted the development of the AHCPR Clinical Practice Guideline for Acute Pain Management, which was published in 1992. In addition to reviewing the pain guideline, this article includes updated information on ketorolac tromethamine, tramadol, local anesthetics, sedation, regional anesthetic techniques, and the management of opioid adverse effects.

CONCLUSIONS: The AHCPR Clinical Practice Guideline for Acute Pain Management is a comprehensive, yet functional, review for clinicians. Most issues relating to acute pain assessment and management are adequately discussed. Overall, this guideline is a worthwhile general resource to clinicians. It is important, however, for clinicians managing acute pain issues to supplement this guideline with more detailed and current information.

Follin SL, Charland SL
St. Joseph Hospital, Denver, CO 80218, USA.
Ann Pharmacother 1997 Sep;31(9):1068-76
Publication Types: Review; Review, tutorial



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Role of epidural tramadol hydrochloride on postoperative pain relief in caesarean section delivery.

Two groups comprising 25 patients in each went for caesarean section delivery under epidural anaesthesia. Group I patients received 50 mg (1 ml) of tramadol hydrochloride with 14 ml of 2% lignocaine with adrenaline (1:200,000) and group II cases received 15 ml of 2% lignocaine with adrenaline (1:200,000). Both the groups of patients were comparable in age and body weight. In both the groups, there were good operative conditions, insignificant changes in pulse and blood pressure. The neonatal status was also similar in both the groups. The patients belonging to group I showed longer duration (15.39 +/- 0.45 hours) of analgesia in comparison to group II patients (2.46 +/- 0.54 hours).

Pan AK, Mukherjee P, Rudra A
NRS Medical College and Hospital, Calcutta.
J Indian Med Assoc 1997 Apr;95(4):105-6



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Tramadol versus hydrocodone-acetaminophen in acute musculoskeletal pain: a randomized, double-blind clinical trial.

STUDY OBJECTIVE: To evaluate the efficacy of an oral tramadol preparation versus that of an oral hydrocodone-acetaminophen preparation in acute musculoskeletal pain.

METHODS: A randomized, prospective, double-blind clinical trial was conducted in an urban teaching emergency department with an annual census of 41,000. Participants comprised a convenience sample of 68 adult ED patients with acute musculoskeletal pain caused by minor trauma. Thirty-three patients received tramadol (100 mg), and 35 patients received hydrocodone-acetaminophen (5 mg hydrocodone with 500 mg acetaminophen). The drugs were prepared in identical-appearing capsules. Pain was evaluated by a 100-mm visual analog scale (VAS) at baseline and at 30, 60, 90, 120, and 180 minutes after dosing. VAS scores were analyzed by 2-way repeated-measures ANOVA, and nominal data were analyzed by Fisher's exact test.

RESULTS: Mean pain scores did not differ at baseline (tramadol, 68.3+/-21.8; hydrocodone-acetaminophen, 69.1+/-17.8; P=NS) but were significantly lower in the hydrocodone-acetaminophen group beginning at 30 minutes through 180 minutes. There were 6 dropouts as a result of reported inadequate analgesia, 3 in each group (P=NS). The discharge diagnoses and prevalence of side effects did not differ significantly between groups.

CONCLUSION: Tramadol provides inferior analgesia to hydrocodone-acetaminophen in ED patients with acute musculoskeletal pain.

Turturro MA, Paris PM, Larkin GL
Department of Emergency Medicine, The Mercy Hospital of Pittsburgh, PA, USA. turturro+@pitt.edu
Ann Emerg Med 1998 Aug;32(2):139-43
Publication Types: Clinical trial, Randomized controlled trial



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[A comparison of a tramadol/metamizole infusion with the combination tramadol infusion plus ibuprofen suppositories for postoperative pain management following hysterectomy].

Postoperative pain management is still a grossly neglected field. In most cases, antipyretic analgesics alone are insufficient during the early postoperative period. Powerful narcotics are often avoided or underdosed because they are associated with the risk of respiratory depression. Some authors recommend combined infusion of tramadol and metamizole, which is assumed to provide sufficient pain relief without the risk of respiratory depression. However, this regimen has not yet been investigated in a study that meets currently accepted scientific standards.

METHODS. Sixty patients who underwent vaginal hysterectomy were included in a randomised, prospective double-blind study. Thirty women received two placebo suppositories immediately after induction of anaesthesia and a postoperative infusion of tramadol and metamizole (400 mg tramadol plus 5 g [= 10 ml] metamizole in 500 ml electrolyte solution). The 30 women of the control group received two ibuprofen suppositories (585.2 mg) preoperatively and a post-operative tramadol infusion (400 mg tramadol plus 10 ml placebo [NaCl 0.9%] in 500 mg electrolyte solution). The patients of both groups received 125 ml of the appropriate infusion solution as a loading dose over 10 min (corresponding to 1.25 mg metamizole and 100 mg tramadol in the metamizole/tramadol group or 100 mg tramadol in the ibuprofen/tramadol group) 10 min after awakening. The remaining solution was administered at an infusion rate of 12.5-25 ml/h (corresponding to 125-250 mg metamizole and 10-20 mg tramadol/h or 10-20 mg tramadol/h). On request or when complaining of stronger pain, the patients received an additional bolus infusion of 125 ml over 10 min. In case of insufficient pain reduction despite repeated infusion of 125-ml boli or consumption of the entire infusion solution, the patients discontinued the study and received demand-adapted intravenous titration of piritramide. Postoperative pain was evaluated on the visual analogue scale (VAS) and the 101-point numerical rating scale immediately before the start of the infusion. Pain evaluation was repeated 20, 30, 40, 60, 100, 120, and 240 min after awakening accompanied by registration of heart rate, respiratory rate, systolic and diastolic blood pressure, and side effects.

RESULTS. About 60% of the entire infusion solution was administered within 60 min in both groups. Significant postoperative pain reduction in both groups and on both the 101-point scale and the VAS was observed only at 100, 120, and 240 min after awakening. In the tramadol/metamizole group, nausea occurred in 7 cases and vomiting in 1. Nine patients in this group additionally required intravenous piritramide because of insufficient pain relief. In the tramadol/ibuprofen group, 8 patients complained about nausea and 4 patients vomited. Six patients additionally received intravenous piritramide because of insufficient pain reduction.

CONCLUSIONS. Satisfactory pain reduction occurred rather late despite high doses of both the tramadol/metamizole and the tramadol/ibuprofen. Both analgesic combination must be regarded as insufficient after inhalational anaesthesia because of the very slow onset of action and the high failure rate.

Striebel HW, Hackenberger J
Klinik fur Anaesthesiologie und operative Intensivmedizin, Freie Universitat, Berlin.
Anaesthesist 1992 Jun;41(6):354-60 [Article in German]
Publication Types: Clinical trial; Randomized controlled trial



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Tramadol hydrochloride: analgesic efficacy compared with codeine, aspirin with codeine, and placebo after dental extraction.

Tramadol hydrochloride is a novel, centrally acting analgesic with two complementary mechanisms of action: opioid and aminergic. Relative to codeine, tramadol has similar analgesic properties but may have fewer constipating, euphoric, and respiratory depressant effects. A two-center randomized double-blind controlled clinical trial was performed to assess the analgesic efficacy and reported side effects of tramadol 100 mg, tramadol 50 mg, codeine 60 mg, aspirin (ASA) 650 mg with codeine 60 mg, and placebo. Using a third molar extraction pain model, 200 healthy subjects were enrolled in a 6-hour evaluation after a single dose of drug. Of the 200 patients enrolled, seven provided incomplete efficacy data or discontinued prematurely and one was lost to follow-up. Using standard measures of analgesia, including total pain relief score (TOTPAR), maximum pain relief score (MaxPAR), sum of pain intensity difference scores (SPID), peak pain intensity difference (Peak PID), remedication, and global evaluations, all active treatments were found to be numerically superior to placebo. ASA/codeine was found to be statistically superior to placebo for all measures of efficacy. Tramadol 100 mg was statistically superior to placebo for TOTPAR, SPID, and time of remedication, whereas tramadol 50 mg was statistically superior to placebo only for remedication time. Codeine was not found to be statistically superior to placebo for any efficacy measure. A greater TOTPAR response compared with all other active measures was seen for ASA/codeine during the first 3 hours of study. The 6-hour TOTPAR scores for the tramadol groups and ASA/ codeine group were not significantly different. Gastrointestinal side effects (nausea, dysphagia, vomiting) were reported more frequently with tramadol 100 mg, ASA/ codeine, and codeine 60 mg than with placebo.

Moore PA, Crout RJ, Jackson DL, Schneider LG, Graves RW, Bakos L
Department of Dental Public Health, University of Pittsburgh, School of Dental Medicine, Pennsylvania 15261, USA.
J Clin Pharmacol 1998 Jun;38(6):554-60
Publication Types: Clinical trial, Multicenter study, Randomized controlled trial
malernee
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Tramadol not fda approved

Postby malernee » Sat Feb 26, 2005 4:39 pm

Tramadol
Compend Contin Educ Pract Vet 26[10]:800-802 Oct'04 Pharm Profile 11 Refs

Rebecca Parker, PharmD
University of North Carolina
Indication: Treating chronic, cancer-related, and postoperative pain as well as degenerative joint disease. Tramadol has not been approved by the FDA for use in veterinary medicine. However, in humans it is indicated for treating moderate to moderately severe pain. Reported veterinary uses include treating chronic, cancer-related, and postoperative pain as well as degenerative joint disease. Case reports of effective analgesia with tramadol were presented at the 2003 meeting of the American College of Veterinary Internal Medicine. In humans, several studies have shown analgesia similar to that of morphine.
malernee
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Posts: 462
Joined: Wed Aug 13, 2003 5:56 pm

Morphine and tramadol for pain

Postby malernee » Sat Feb 26, 2005 4:41 pm

A Comparison of Preoperative Tramadol and Morphine for the Control of Early Postoperative Pain in Canine Ovariohysterectomy
Vet Anaesth Analg 30[4]:220-228 Oct'03 Prospective Trial 43 Refs

Sandra Mastrocinque DVM, MS & Denise T. Fantoni DVM, PhD *
* Avenida Professor Orlando Marques Paiva 87 Cidade Universitaria, Sao Paulo, SP 05508 000 Brazil; E-mail: dfamoni@usp.br
OBJECTIVE: To compare morphine with tramadol for the management of early postoperative pain following ovariohysterectomy after pyometra in dogs.

STUDY DESIGN: Prospective randomized blinded clinical trial.

ANIMALS: Thirty female dogs, 2-14 years old.

METHODS: Animals were randomly divided into two equal groups. Group 1 received 0.2 mg kg-1 of morphine IV and group 2 received 2 mg kg-1 of tramadol IV after the induction of anesthesia. The dogs were premedicated with acepromazine, and anesthesia was induced with intravenous midazolam and ketamine. Isoflurane was used for the maintenance of anesthesia. The variables measured were: analgesia; sedation; cardiac and respiratory rates; arterial blood pressure; end-tidal isoflurane and carbon dioxide (PE'CO2); oxyhemoglobin saturation (SPO2); plasma catecholamines; serum cortisol and glucose concentrations; pH and blood gases. The animals were monitored for 6 hours after the administration of the analgesic agent.

RESULTS: There were no differences between the two groups with regard to analgesia, sedation, SpO2, pH and blood gases, cardiovascular variables, glucose, catecholamine and cortisol concentrations. Forty minutes post-opioid administration, the end-tidal isoflurane concentration was significantly lower in the morphine-treated group as compared to the tramadol group. At 30 minutes following opioid injection, PE'CO2 was significantly higher in the morphine group than in the tramadol group. Two dogs in the tramadol group and one in the morphine group were given morphine postoperatively because of increasing pain scores.

CONCLUSION & CLINICAL RELEVANCE: Morphine and tramadol, administered preemptively can be used safely in dogs to control early pain after ovariohysterectomy without significant adverse effects.
malernee
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preoperative tramadol

Postby guest » Thu Jun 23, 2005 9:21 am

Search for
1: J Vet Pharmacol Ther. 2004 Aug;27(4):239-46.Related Articles, Books,
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Pharmacokinetics of tramadol and the metabolite O-desmethyltramadol in
dogs.
KuKanich B, Papich MG.
Department of Molecular Biomedical Sciences, College of Veterinary
Medicine, North Carolina State University, 4700 Hillsborough Street,
Raleigh, NC 27606, USA. butch_kukanich@ncsu.edu
Tramadol is an analgesic and antitussive agent that is metabolized to
O-desmethyltramadol (M1), which is also active. Tramadol and M1 exert
their mode of action through complex interactions between opiate,
adrenergic, and serotonin receptors. The pharmacokinetics of tramadol
and M1 were examined following intravenous and oral tramadol
administration to six healthy dogs, as well as intravenous M1 to three
healthy dogs. The calculated parameters for half-life, volume of
distribution, and total body clearance were 0.80 +/- 0.12 h, 3.79 +/-
0.93 L/kg, and 54.63 +/- 8.19 mL/kg/min following 4.4 mg/kg tramadol HCl
administered intravenously. The systemic availability was 65 +/- 38% and
half-life 1.71 +/- 0.12 h following tramadol 11 mg/kg p.o. M1 had a
half-life of 1.69 +/- 0.45 and 2.18 +/- 0.55 h following intravenous and
oral administration of tramadol. Following intravenous M1 administration
the half-life, volume of distribution, and clearance of M1 were 0.94 +/-
0.09 h, 2.80 +/- 0.15 L/kg, and 34.93 +/- 5.53 mL/kg/min respectively.
Simulated oral dosing regimens at 5 mg/kg every 6 h and 2.5 mg/kg every
4 h predict tramadol and M1 plasma concentrations consistent with
analgesia in humans; however, studies are needed to establish the safety
and efficacy of these doses.
Publication Types:
Clinical Trial
Randomized Controlled Trial
PMID: 15305853 [PubMed - indexed for MEDLINE]
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1: Vet Anaesth Analg. 2003 Oct;30(4):220-8.Related Articles, Books,
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A comparison of preoperative tramadol and morphine for the control of
early postoperative pain in canine ovariohysterectomy.
Mastrocinque S, Fantoni DT.
Surgery Department, School of Veterinary Medicine and Zootechnic,
University of Sao Paulo, Sao Paulo, Brazil.
OBJECTIVE: To compare morphine with tramadol for the management of early
postoperative pain following ovariohysterectomy after pyometra in dogs.
STUDY DESIGN: Prospective randomized blinded clinical trial. ANIMALS:
Thirty female dogs, 2-14 years old. METHODS: Animals were randomly
divided into two equal groups. Group 1 received 0.2 mg kg-1 of morphine
IV and group 2 received 2 mg kg-1 of tramadol IV after the induction of
anesthesia. The dogs were premedicated with acepromazine, and anesthesia
was induced with intravenous midazolam and ketamine. Isoflurane was used
for the maintenance of anesthesia. The variables measured were:
analgesia; sedation; cardiac and respiratory rates; arterial blood
pressure; end-tidal isoflurane and carbon dioxide (Pe'CO2);
oxyhemoglobin saturation (SpO2); plasma catecholamines; serum cortisol
and glucose concentrations; pH and blood gases. The animals were
monitored for 6 hours after the administration of the analgesic agent.
RESULTS: There were no differences between the two groups with regard to
analgesia, sedation, SpO2, pH and blood gases, cardiovascular variables,
glucose, catecholamine and cortisol concentrations. Forty minutes
postopioid administration, the end-tidal isoflurane concentration was
significantly lower in the morphine-treated group as compared to the
tramadol group. At 30 minutes following opioid injection, Pe'CO2 was
significantly higher in the morphine group than in the tramadol group.
Two dogs in the tramadol group and one in the morphine group were given
morphine postoperatively because of increasing pain scores. CONCLUSION
AND CLINICAL RELEVANCE: Morphine and tramadol, administered preemptively
can be used safely in dogs to control early pain after
ovariohysterectomy without significant adverse effects.
Publication Types:
Clinical Trial
Randomized Controlled Trial
PMID: 12925179 [PubMed - indexed for MEDLINE]
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1: Xenobiotica. 2001 Jul;31(7):423-41.Related Articles, Books, LinkOut
Metabolism of the analgesic drug, tramadol hydrochloride, in rat and
dog.
Wu WN, McKown LA, Gauthier AD, Jones WJ, Raffa RB.
Division of Preclinical Development, The R.W. Johnson Pharmaceutical
Research Institute, Spring House, PA 19477, USA.
1. Metabolism of the analgesic agent, tramadol hydrochloride, was
investigated after a single oral administration of 14C-tramadol to four
rats (50)mgkg(-1) and two dogs (20)mg kg(-1). 2. Recovery of total
radioactivity in rat and dog urine samples over 24 h was 73 and 65% of
the radioactive dose, respectively. 3. Unchanged tramadol and a total of
24 metabolites, consisting of 16 Phase I metabolites and eight
conjugates (seven glucuromides, one sulphate), were isolated and
tentatively identified, which accounted for > 52% of the dose in urine
of both species. 4. Of the metabolites, five (M1-5) were previously
identified. 5. The metabolites were formed via the following six
metabolic pathways: O-demethylation, N-demethylation, cyclohexyl
oxidation, oxidative N-dealkylation, dehydration and conjugation. 6.
Pathways 1-3 appear to be major steps, forming seven
O-desmethyl/N-desmethyl and hydroxy-cyclohexyl metabolites in major
quantities. 7. Pathways 1-3 in conjunction with pathway 6 produced four
glucuronides along with four minor conjugates. 8. In addition, the in
vitro metabolism of tramadol was conducted using rat hepatic S9 fraction
in the presence of an NADPH-generating system. Unchanged tramadol (30%
of the sample) plus nine metabolites, M1-7, tramadol-N-oxide (M31) and
OH-cyclohexyl-M1 (M32), were profiled and tentatively identified based
on MS and MS/MS data.
PMID: 11531006 [PubMed - indexed for MEDLINE]
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Tramadol for pain of osteoarthritis study

Postby malernee » Wed Apr 05, 2006 10:43 am

Tramadol/acetaminophen for pain of osteoarthritis flares

American Family Physician, Jan 1, 2005 by Caroline Wellbery

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Nonsteroidal anti-inflammatory drugs (NSAIDs) are effective for pain caused by osteoarthritis, but their usefulness is limited by side effects. Tramadol combined with acetaminophen is recommended, according to the new American Pain Society guidelines, for the treatment of osteoarthritis pain when NSAIDs alone cannot provide adequate pain relief. This study is an extension of an earlier study evaluating the efficacy of tramadol/acetaminophen in the treatment of osteoarthritis flares. Rosenthal and colleagues hypothesized that the combination of tramadol/acetaminophen would be safe and effective in a subset of elderly patients.

Eligible patients 65 years and older had symptomatic osteoarthritis of the hip or knee for one year or longer, were taking a stable dosage of an NSAID or a cyclooxy-genase-2 inhibitor, and were in general good health. Patients were randomized to receive an initial single dose of one to two pills of tramadol/acetaminophen or placebo at the first sign of an osteoarthritis flare. After that, patients could take one to two pills up to four times a day as needed, while continuing their regular NSAID regimen.

Primary outcomes were pain intensity and pain relief, scored according to a four-point assessment. Secondary outcomes included overall medication assessment, efficacy over time, and osteoarthritis symptoms, with the latter assessed using a specialized scoring system, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), based on a five-point scale. Patients assessed pain before the first dose and at regular intervals up to four hours after the dose.

The subset studied included 113 elderly patients, with a dropout rate of 17.4 percent in the tramadol/acetaminophen group and 9.1 percent in the placebo group, primarily because of adverse events. Pain intensity scores decreased by 2.10 in the tramadol/acetaminophen group and by 1.63 in the placebo group. Decreases in pain intensity and pain relief scores showed statistically significant improvement in the tramadol/acetaminophen group compared with the placebo group. WOMAC scores were significantly better in the treated group in two of three subscales and in an overall derived score, as were investigator and patient overall medication assessments. These results were similar to those of the study group as a whole. Common adverse events among the treated group were nausea, vomiting, and dizziness.

The authors conclude that treating osteoarthritis flares with tramadol/acetaminophen provides significant pain relief over placebo in patients taking a stable dosage of an NSAID.

Rosenthal NR, et al., for the CAPSS-105 Study Group. Tramadol/acetaminophen combination tablets for the treatment of pain associated with osteoarthritis flare in an elderly patient population. J Am Geriatr Soc March 2004;52:374-80.
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