From the Guidelines
Tramadol should be avoided in patients with chronic kidney disease (CKD), especially those with a glomerular filtration rate (GFR) less than 30 mL/min/1.73 m2, due to the risk of accumulation and increased adverse effects. According to the most recent guideline evidence 1, opioids primarily eliminated in urine, such as tramadol, should be avoided in patients with renal impairment, unless there are no alternatives. The evidence suggests that tramadol can accumulate in renal impairment, potentially leading to increased adverse effects such as respiratory depression, seizures, and serotonin syndrome 1.
Key considerations for tramadol use in CKD patients include:
- Dose adjustments are necessary, but even with adjustments, the risk of adverse effects remains high
- Close monitoring for side effects is essential, but may not be sufficient to prevent adverse effects
- Alternative pain management options with less renal impact should be considered, depending on the patient's pain severity and overall clinical condition
- Patients on dialysis require additional considerations, as approximately 7% of tramadol is removed during a 4-hour dialysis session 1
In patients with CKD, it is recommended to use opioids with no active metabolites, such as fentanyl, sufentanil, or methadone, which are preferred due to their lower risk of accumulation and adverse effects 1. Methadone, in particular, may be a suitable alternative, as it is excreted fecally and can be used in patients with renal impairment. However, methadone should be administered only by clinicians experienced in its use, due to the risk of accumulation 1.
From the FDA Drug Label
- 5 Patients with Renal Impairment The limited availability of dose strengths and once daily dosing of Tramadol Hydrochloride Extended-Release do not permit the dosing flexibility required for safe use in patients with severe renal impairment. Do not use Tramadol Hydrochloride Extended-Release in patients with creatinine clearance less than 30 mL/min [see USE IN SPECIFIC POPULATIONS (8. 6) and CLINICAL PHARMACOLOGY (12.3)].
Special Populations: Renal Impairment Impaired renal function results in a decreased rate and extent of excretion of tramadol and its active metabolite, M1 The pharmacokinetics of tramadol was studied in patients with mild or moderate renal impairment after receiving multiple doses of an extended-release tramadol product at 100 mg There is no consistent trend observed for tramadol exposure related to renal function in patients with mild (CLcr: 50-80 mL/min) or moderate (CLcr: 30-50 mL/min) renal impairment in comparison to patients with normal renal function (CLcr > 80 mL/min).
- 6 Patients with Renal Impairment Tramadol Hydrochloride Extended-Release has not been studied in patients with renal impairment. Impaired renal function results in a decreased rate and extent of excretion of tramadol and its active metabolite, M1 The limited availability of dose strengths of Tramadol Hydrochloride Extended-Release does not permit the dosing flexibility required for safe use in patients with severe renal impairment. Therefore, Tramadol Hydrochloride Extended-Release should not be used in patients with severe renal impairment [see DOSAGE AND ADMINISTRATION (2.3), WARNINGS AND PRECAUTIONS (5.14), and CLINICAL PHARMACOLOGY (12. 3)].
Tramadol Administration in CKD Patients: The provided drug labels do not directly address the administration of intramuscular (IM) Tramadol in patients with chronic kidney disease (CKD). However, the labels discuss the use of Tramadol Hydrochloride Extended-Release in patients with renal impairment.
- Severe Renal Impairment: The labels advise against using Tramadol Hydrochloride Extended-Release in patients with severe renal impairment (creatinine clearance less than 30 mL/min) due to the limited availability of dose strengths and the resulting lack of dosing flexibility required for safe use.
- Mild or Moderate Renal Impairment: There is no consistent trend observed for tramadol exposure related to renal function in patients with mild (CLcr: 50-80 mL/min) or moderate (CLcr: 30-50 mL/min) renal impairment compared to patients with normal renal function. Considering the information provided and the lack of direct guidance on IM Tramadol administration in CKD patients, caution is advised. The decision to administer Tramadol to a patient with CKD should be made on a case-by-case basis, taking into account the severity of the renal impairment and the potential risks and benefits of treatment. Key Considerations:
- Dose Adjustment: May be necessary in patients with renal impairment to avoid accumulation of the drug and its active metabolite.
- Monitoring: Close monitoring of the patient's renal function and for signs of tramadol toxicity is recommended.
- Alternative Treatments: Consideration of alternative pain management options that are safer in patients with CKD may be necessary. 2, 2, 2
From the Research
Opioid Use in CKD Patients
- The use of opioids in patients with chronic kidney disease (CKD) requires careful consideration due to altered pharmacokinetics and the risk of adverse events 3, 4, 5.
- Tramadol can be used with caution in CKD patients, but careful monitoring and dose adjustment are necessary 3, 5, 6.
Safe Opioid Options for CKD Patients
- Oxycodone, hydromorphone, fentanyl, methadone, and buprenorphine are considered safer options for CKD patients, but require careful monitoring and dose adjustment 3, 4, 5, 6.
- Transdermal buprenorphine, transdermal fentanyl, and oral hydromorphone are the most tolerable opioids in older, nondialysis CKD patients 6.
Opioids to Avoid in CKD Patients
- Morphine and codeine should be avoided in CKD patients due to the risk of accumulation and adverse events 3, 5, 6.
- Tramadol, codeine, morphine, and meperidine should be avoided in older, nondialysis CKD patients due to the risk of accumulation and adverse events 6.