Tramadol
Tramadol: an Analgesic Tramadol, also know as Saliva ER, Saliva Flashdose, Ultram, Ultram ER, and Ultram ODT, is an synthetic, centrally acting opioid analgesic. Ultracet is a combination drug of acetaminophen and tramadol. Tramadol can be taken orally four times daily. Extended-release tablet called Tramadol ER may be administered once daily (Hair, Curran, & Keam 2006). The recommended dose of tramadol is 50-100 mg (immediate release tablets) every 4-6 hours as needed for pain. The maximum dose is 400 mg/day.
To improve tolerance patients should be started at 25 mg/day, and doses may be increased by 25 mg every 3 days to reach 100 mg/day (25 mg 4 times daily). Thereafter, doses can be increased by 50 mg every 3 days to reach 200 mg day (50 mg 4 times daily). Tramadol may be taken with or without food. Recommended dose for extended release tablets is 100 mg daily which may be increased by 100 mg every 5 days but not to exceed 300 mg /day. Extended release tablets should be swallowed whole and not crushed or chewed. ” (Ogbru & Marks 2010, p. 1)
Ultracet is indicated for short-term therapy of acute pain and should not be taken for long term. Tramadol is used to manage moderate to severe pain in adults. It has been indicated that tramadol is significantly more effective than placebo drugs (Hair, Curran & Keam 2007). Tramadol is less effective than morphine but just as effective as codeine when combined with acetaminophen or aspirin (Lehne 2010). Tramadol is a white, bitter, crystalline and odorless powder which is almost completely absorbed rapidly after oral administration and reaches peak plasma levels in two hours.
The absolute bioavailability is 75% when using a 100 mg tablet and is not affected by food. Tramadol has a steady state distribution of two days when using 100 mg four times daily. The plasma half-life of tramadol for single or multiple dosing is six to seven hours. It is metabolized extensively in the liver and may cross the blood-brain barrier. Ninety percent of tramadol and its metabolites are excreted in the urine and about thirty percent of the unchanged portion is also excreted in the urine. It is readily soluble in water and ethanol and has a pKa of 9. 41 (www. rxlist. com/ultram-drug. htm).
Tramadol is metabolized via the CYP2D6 isoenzyme of cytochrome P450 to an active metabolite which binds to µ receptors. Patients who metabolize drugs poorly via CYP2D6 may get less benefit from tramadol due to reduced formation of its active metabolite. Tramadol is also metabolized by CYP3A4 so its activity is reduced by drugs which induce CYP3A4, such as rifabutin, rifampicin, rifapentine, carbamazepine, phenobarbital, phenytoin or St. John’s Wort (Kaye 2004). Indicators of effectiveness include: relief of acute or chronic pain, relief of stiffness, increase in physical mobility and a decrease in the pain scale.
Therapeutic index is usually reached within one hour of dosage, when aspirin and/or paracetamol alone are inappropriate or have failed. Like most drugs, tramadol has its own set of side effects, interactions, and contradictions. tramadol side effects are caused from re-uptake of serotonin and noradrenaline and stimulation of opiate receptor (Close 2005). Side effects related to the central nervous system include dizziness, drowsiness (excluding vertigo), headache, anxiety, confusion, flushing, hallucinations and euphoria.
Cardiovascular side effects are vasodilation, orthostatic hypotension, tachycardia and hypertension. Nausea, vomiting, dry mouth, diarrhea, anorexia flatulence, GI bleed and constipation are common gastrointestinal side effects. Regarding the urinary tract, menstrual disorder, dysuria, menopausal symptoms, urinary frequency and urinary retention are side effects. Patient could have problems with pruritus, urticaria and rashes. Significant adverse affects consist of seizures, anaphylaxis, serotonin syndrome, hypersensitivity reactions, toxic epidermal necrosis and Steven-Johnson syndrome (Skidmore-Roth L. 009). “Seizures have been reported in over 280 patients, and hence the drug should be avoided in patients with epilepsy and other neurologic disorders” (Lehne 2010, p. 280). Since tramadol is metabolized by the liver and excreted by the kidneys, it is important to assess patient for liver and kidney disease. These two diseases could prolong half-lives of tramadol and increase damage to the liver and kidney. It is recommended, in cases like this, that the dosage be reduced by half with an increase in dosage intervals. Dosage reductions are also recommended for patients over 75 years of age.
The risk for falls in the elderly is also a side effect when taking this drug (Philip 2007). “By inhibiting uptake of norepinephrine, tramadol can precipitate a hypertensive crisis if combined with an MAO inhibitor. Accordingly, the combination is absolutely contraindicated” (Lehne 2010, p. 280). If tramadol is administered with other serotonergic drugs (like opioids, anorectics or antidepressants), the effects of serotonin syndrome and seizure greatly increases because this drug inhibits uptake of serotonin therefore decreasing the effects of the serotonergic drugs.
The consumption of alcohol or use of CNS depressant drugs while taking tramadol can cause an increase in CNS depression effects and lead to addiction. Carbamazepine will decrease the level of tramadol which will decrease the therapeutic effects of this drug, therefore an increased dose may be needed. If patient is hypersensitive or taking any CNS depressant drugs they should not take tramadol because of the increased effect. Tramadol should not be given to patients with a history of drug or alcohol addictions. Controversy exists in regards to the effects of tramadol on children.
Some sources state tramadol is not meant for children under the age of eighteen (drugs. com). However, other sources indicate that 2 mg/kg is safe for minors (Finkel et al. , 2002). Yet other sources indicate 3mg/kg is safe. No studies were identified that prove tramadol has adverse effects on children, but two studies did indicate tramadol is safe and effective in children. It has been determined that 1-2 mg/kg by mouth every 4-6 hours is a safe and effective analgesic in patients seven to sixteen, when using it for no more than 30 days. Tramadol seems to be both effective and well tolerated in this pediatric population” (Finkel et al. , 2002, p. 1473). Another study examined the effects of Tramadol on a day case dental extraction with children ages 4 years to 7 years, each child having at least six teeth extracted. Thirty minutes from prior to the anesthetics, which was administered before the procedure, forty children received 3mg/kg of tramadol drops combined with 0. 5 mg/kg oral midazolam (group T) and ten children were given placebo (group P) where no tramadol was administered.
It is concluded that tramadol at 3 mg/kg has no clinical respiratory depressant effect and that behavior and recovery times are unaffected (Payne & Roelofse 2000). Tramadol is a pregnancy category C and therefore should not be taken during pregnancy or delivery. Administration of this medicine during this time could be harmful to the unborn baby causing severe or fatal side effects including withdrawal symptoms. If the mother plans to breast-feed her baby, she is advised not to take tramadol because it can pass into breast milk and may harm the nursing infant.
Therefore, it is imperative that the patient tell their doctor if they are pregnant or plan to become pregnant, because this drug is a pregnancy category C. “A case of tramadol withdrawal in a neonate has been reported following long-term analgesic treatment of the mother. At 35 hours of age, the infant showed signs of a severe withdrawal syndrome with high-pitched crying, trembling, and shortened sleeping hours” (www. drugs. com). In regards to pregnant and nursing mothers, all rewarded documents emphasized the importance for these patients not taking tramadol due to effects on the baby.
Adults may take 50 to 100 mg by mouth as needed ever four to six hours, but cannot exceed 400 mg in on twenty four hour time period. If the patient is over seventy five years of age they should not exceed 300 mg in a twenty four hour period. The patient needs to report any symptoms of central nervous system changes and allergic reactions to their health care provider immediately. In order for the patient to effectively monitor this, nurses need to teach them the signs and symptoms of side effects. Central nervous system effects include, dizziness, drowsiness, hallucinations, euphoria, LOC and pupil reaction.
Allergic reactions include rash and urticaria (itching). If a patient has any dizziness, drowsiness and confusion they need to also call someone for assistance in order to decrease the risk of falling and injuring themselves. This drug can also cause orthostatic hypertension indicating a need for the patient to be taught the importance of making positioning changes slowly in order to prevent fainting. Teach patient to dangle their legs off the side of the bed before standing up otherwise fainting could occur. The patient also needs to be aware that over the counter medications and the use of alcohol are to be avoided.
Teach the patient that over the counter drugs can sometime have reactions toward tramadol and alcohol can increase the chance for central nervous system depression to occur, therefore teaching the patience to take this pain medicine at the beginning of the pain onset and not after the pain has become severe is important (Skidmore-Roth 2009). Nurses may be confident that the patient’s learning has been effective through demonstration of the three major components of learning including: cognitive, objective and psychomotor.
Cognitively the patient will demonstrate the ability to repeat serious side effects to be aware of to the health care provider in their own words showing they understand. Next, the patient will objectively learn by paying attention and asking questions for clarification, when needed, showing they have the desire to learn. Finally the patient will be able to demonstrate psychomotor learning thru adaptation, because she will be able to change her motor response when problems occur. The patient will be able to call the health care provider when or if problems occur and they will understand the importance of complying with the teaching received.
In conclusion we discussed the drug tramadol, which is a synthetic centrally acting opioid analgesic used for acute and chronic pain. Dosages range depending on age and any issues with renal or hepatic impairment. The pharmacokinetics section discusses absorption, distribution, metabolism, elimination and effectiveness of the drug. The half life this drug is six to seven hours, it is metabolized in the liver and excreted thru the kidneys. The pain scale is the best way to indicate effectiveness of the drug, which would show a decrease in the scale.
Side effects, interactions and contradictions are common in this drug just like any other medication. Patients with decreased hepatic and renal function need to be cautious when using this drug. Central nervous changes, allergic reaction and constipation are common causes. Risks to mother, who are pregnant or nursing, exist and they should not take this drug due to the life threatening effects it may have on the baby. There is controversy on whether this drug should be administered in those under the age of sixteen, because of effects it may have on respiratory tract.
Adults over the age of seventy five years should not exceed 400 mg/kg in a twenty four hour period and must contact their health care provider if a rash develops or if there is any change in central nervous system. It is also important to stay away from over the counter drugs unless their health care provider as approved them and to stay away from alcohol because it could increase the chance of central nervous system depression. In order for tramadol to be the most effective it is important that the patient take it at the onset of pain and not after the pain becomes severe.
Comprehensive education of the patient regarding drug mechanism benefits, side effects and dosing helps promote safe usage of this prescription drug. The best way t to facilitate the education is through cognitive, objective and psychomotor learning techniques. References Close B. (2005) Tramadol: does it have a role in emergency medicine? Emergency Medicine Australasia, 17, 73-83. Drugs: Drug Information Online. (2010) Tramadol Pregnancy and Breast-feeding Warnings. Retrieved from http://www. drugs. com/pregnancy/tramadol. html Finkel J. , Rose J. , Schmitz M. , Birmingham P. , Ulma G. , Gunter J. Cnaan A. , Cote C. ,Aedve R. , Schreiner M. (2002) An Evaluation of the Efficacy and Tolerability of Oral Tramadol Hydrochloride Tablets for the Treatment of Postsurgical Pain in Children. Anesth Analg, 94, 1469-1473. Hair P. , Curran M. , Keam S. (2006) Tramadol Extended-Release Tablets. Drugs, 66(15), 2017-2027. Hair P. , Curran M. , Keam S. (2007) Tramadol Extended-Release Tablets in Moderate to Moderately Sever Chronic Pain in Adults. CNS Drugs, 21(3), 259-263. Lehne R. (2010). Pharmacology for Nursing Care. St. Louis: Saunders Elsevier. Kaye, K. (2004). Austrailian Prescriber: Trouble with Tramadol.
Retrieved from http://www. australianprescriber. com/magazine/27/2/26/7/. Ogbru O. , Marks J. (2010) Medications and Drugs: tramadol (Ultram, Ultram ER). Retrieved from http://www. medicinenet. com/tramadol/article. htm. Payne K. A. , Roelofse J. A. (2000) Tramadol drops in children: analgesic efficacy, lack of respiratory effects, and normal recovery times. RxList: The Internet Drug Index. (2008) Ultram (tramadol hydrochloride) Drug. Retrieved from http://www. rxlist. com/ultram-drug. htm. Skidmore-Roth L. (2009). Mosby’s Drug Guide for Nurses. St. Louis: Mosby Elsevier.
