Vomiting due to tramadol: a short report from the regional pharmacovigilance center, Western NepalCorrespondence Address :
P.Subish M. Pharm, Assistant Professor, Department of Pharmacy / Pharmacology , Manipal Teaching Hospital/ Manipal College of Medical Sciences
Pokhara, Nepal. Email: email@example.com
Vomiting, Tramadol, Nepal
Tramadol is an atypical, centrally acting analgesic, having an inherent multimodal action on opoid receptors, as well as on noradrenergic and serotonergic receptors.(1) It is an effective analgesic in moderate, and in some cases, severe pain(2), and has a place in pain management, in patients who do not respond to simple analgesics, and in whom NonSteroidal Anti Inflammatory Drugs (NSAIDs) are contraindicated.(3) In comparative studies in postoperative and post trauma pain, 100 mg of tramadol given intramuscularly or intravenously, was equivalent to 5- 10 mg of morphine.(3) Unlike other opoids, tramadol is not usually associated with development of tolerance, physical dependence, or psychological addiction, and has a reduced incidence and severity of opoid adverse effects, particularly respiratory depression, ileus and constipation(1), (4)
However, it may increase risk of seizure in susceptible patients with a history of epilepsy, or patients on antiseizure drugs.(4) As with other opoids, nausea and vomiting remain as problems in tramadol too. In this short communication, the authors highlight on vomiting due to Tramadol, and narrate their experiences regarding the reports of vomiting due to tramadol.
The manipal Teaching Hospital (MTH) runs an Adverse Drug Reaction (ADR) monitoring program since September 2004. MTH is also recognized as the regional Pharmacovigilance center for ADR monitoring in the Western region of Nepal. Upon occurrence of an ADR due to a drug, it is reported to the Pharmacovigilance Center by Clinicians, Pharmacists and Nurses, by filling the ADR reporting forms. The ADR reports of tramadol induced vomiting received by the center till March 2006, are included in the analysis. The patientâ€™s case records were also analyzed for detailed evaluation. The causality assessment was carried out as per the Naranjo algorithm. (5)
Altogether the center received a total of seven reports of vomiting due to tramadol during the study period. The details regarding the patients and the vomiting due to tramadol are listed in (Table/Fig 1).
Incidence of vomiting due to tramadol: The most frequent adverse gastrointestinal effects of tramadol are nausea (10% to 20%), and vomiting (3% to 9%). Vomiting has necessitated withdrawal of therapy in some patients(6),(7),(8). Nausea occurred in 24, 34 and 40% of patients, and vomiting occurred in 9, 13 and 17% of patients receiving the drug for up to 7, 30, and 90 days, respectively. Nausea and vomiting may occur more frequently with higher doses and following rapid intravenous injection. (9)
Clinical trials involving tramadol administration for up to 90 days in 550 patients, reported nausea in 24% to 40%, constipation in 24% to 46%, and vomiting in 9% to 17% of patients. Medical conditions and other medications were present in some cases. (10)
In order to prevent the occurrence of similar ADRs in the future, there is a need for establishing the causal relation ship between the drug and the ADR. Several scales are used to carry out the causality assessment. We used Naranjo algorithm, (5) one of the commonly used algorithms, to carry out the causality assessment. It is an algorithm that is used to categorize ADRs as possibly, probably, or definitely due to a certain drug. It is based on the score calculated on the basis of points given for each of ten questions that comprises the algorithm. On a scale of 13, if the score is greater than 9, then the adverse reaction is categorized as definitely caused by the particular drug. A score of (5-8) is categorized as probable, while a score of (1-4) is categorized as possible. We found that all the cases of vomiting had a â€˜probableâ€™ relationship with tramadol. We could not confirm the diagnosis, as we did not perform the rechallenge.
Management of vomiting due to tramadol:
Metoclopramide has been useful in treating nausea and vomiting due to tramadol administration. A slow titration schedule starting at 25 milligrams (mg) daily, then increasing by 25-mg increments every 3 days to a target daily dose of 150 mg (in 13 days) or 200 mg (in 16 days), was associated with a significantly lower incidence of discontinuation due to nausea and/or vomiting, as compared to a faster 10-day titration to 200 mg (22% versus 46%, respectively; p = 0.008 and 0.006, respectively) in a controlled study of subjects previously intolerant to tramadol.(6), (11)
Analgesic potency of tramadol:
In comparative studies in postoperative and post-trauma pain, 100 mg of tramadol given intramuscularly or intravenously was equivalent to 5â€“10 mg of morphine. However, in severe pain associated with either surgery or cancer, morphine was more effective than tramadol, and remains the drug of choice. In acute and chronic non-malignant pain, oral tramadol 100 mg is comparable to a combination of paracetamol and codeine (1000 mg/60 mg). There have been few direct comparisons of tramadol with non-steroidal anti-inflammatory drugs, but the efficacy appears to be similar. (3)
Our experience suggests that the decision to prescribe tramadol should not be a trivial one. Tramadol has a place in pain management for selected patients who have not responded to simple analgesics such as paracetamol or aspirin, and in whom NSAIDs are contraindicated. For most patients, a combination of paracetamol and codeine will be equally effective, and possibly better tolerated than tramadol. Prior to prescribing tramadol to a patient, one should keep in mind the gastrointestinal effects of tramadol, and also the other potential side effects such as increased risk of seizures etc.
Appendix 1- (Table/Fig 2)
The authors acknowledge Dr. Mukhyaprana Prabhu, Associate Professor, Department of Medicine, Kasturba Medical College, Manipal, Karnataka, India, for reviewing the initial version of the manuscript and suggesting modifications.
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