Is tramadol safe to use in patients with CKD?

Comment by InpharmD Researcher

There is a lack of studies evaluating the long-term effects of tramadol use alone on renal outcomes in patients with CKD. As tramadol and its active metabolites primarily undergo renal elimination, product labels caution the use of immediate-release tramadol in CrCl <30 mL/min with proposed dose adjustments; whereas extended-release formulations should be avoided in patients with severe renal impairment. Due to the increased risk for respiratory depression, seizures, and CNS effects, its use in the elderly with CKD is not recommended.

Background

A 2017 review discusses pain management for patients with chronic kidney disease (CKD). For patients with moderate pain (score of 4 to 6) and CKD, tramadol may be considered because it is not known to be directly nephrotoxic. In patients with advanced CKD (estimated glomerular filtration rate <30 mL/min/1.73 m2), tramadol and its metabolite can accumulate causing increased blood levels, which can lead to respiratory depression and reduced seizure threshold. The authors do not report whether there is a potential for tramadol accumulation to precipitate renal failure in patients with CKD. [1]

A 2018 review stated that tramadol is often a safer option over NSAIDs for pain management in CKD patients. However, due to its dual mechanism of action as a central opioid agonist and central nervous system (CNS) reuptake inhibitor of serotonin and norepinephrine, the O-demethylation product of tramadol metabolism has a greater affinity for opioid mu-receptor than the original compound. Variability in the conversion can be introduced depending on the patients receiving tramadol, who can be slow, fast, or ultra-fast metabolizers of the drug. The authors suggested that the resulting potential adverse effects (seizures, hypoglycemia, serotonin syndrome, and opioid dependence) may be unpredictable. [2]

Additionally, a 2019 review specifically discussed opioid management, including the use of tramadol, in older adults with CKD. Tramadol and its active metabolites are predominantly renally cleared. As recommended by tramadol’s product labels, renal dose adjustment is required with immediate-release formulation in individuals with creatinine clearance (CrCl) <30 mL/min; whereas the use of extended-release formulation should be avoided in this population. Concerning the increased risk of seizures and central nervous system adverse effects in older adults with CKD with prolonged tramadol exposure, researchers recommend against either formulation in the elderly with CKD. [3]

A 2020 prospective cohort study conducted a comparative analysis of harm from opioids versus NSAIDs in CKD, using 30-day analgesic use reported at annual visits of 3,939 patients with CKD in the Chronic Renal Insufficiency Cohort (CRIC) study. Over a median follow-up of 6.84 years, 391 (9.9%) and 612 (15.5%) participants reported baseline opioid and NSAID use, respectively. A sub-cohort analysis was also conducted, including patients who ever consumed another (non-opioid, non-NSAID) analgesic or tramadol at baseline or during follow-up as a surrogate for the need of pain relief. Specifically, 18/391 (4.6%) opioid users and 17/612 (2.8%) NSAID users received tramadol at baseline as well. Pooled results demonstrated time-updated opioid use to be associated with the kidney disease composite outcome, kidney failure with kidney replacement therapy (KRT), death (hazard ratio of 1.4 [95% confidence interval (CI) 1.2 to 1.7], 1.4 [95% CI 1.1 to 1.7], and 1.5 [95% CI 1.2 to 2.0], respectively), and hospitalization (rate ratio 1.7; 95% CI 1.6 to 1.9) versus opioid non-users. Sub-cohort analysis of participants with exposure to other analgesics or tramadol showed similar results. While time-upated NSAID use was also found to be associated with an increased risk for the kidney disease composite and hospitalization, results were not significant in the sub-cohort. Findings from this observational study are limited to recall bias on analgesic use and unadjusted confounding factors, such as indication. Additionally, use of tramadol is not evaluated as an individual analgesic in terms of its long-term effects on renal outcomes in CKD patients. [4]

References: [1] Pham PC, Khaing K, Sievers TM, et al. 2017 update on pain management in patients with chronic kidney disease. Clin Kidney J. 2017;10(5):688-697. doi:10.1093/ckj/sfx080
[2] Sriperumbuduri S, Hiremath S. The case for cautious consumption: NSAIDs in chronic kidney disease. Curr Opin Nephrol Hypertens. 2019;28(2):163-170. doi:10.1097/MNH.0000000000000473
[3] Owsiany MT, Hawley CE, Triantafylidis LK, Paik JM. Opioid Management in Older Adults with Chronic Kidney Disease: A Review. Am J Med. 2019;132(12):1386-1393. doi:10.1016/j.amjmed.2019.06.014
[4] Zhan M, Doerfler RM, Xie D, et al. Association of Opioids and Nonsteroidal Anti-inflammatory Drugs With Outcomes in CKD: Findings From the CRIC (Chronic Renal Insufficiency Cohort) Study. Am J Kidney Dis. 2020;76(2):184-193. doi:10.1053/j.ajkd.2019.12.010
Relevant Prescribing Information

Dosage and Administration
Dosage Modification in Patients with Renal Impairment
In all patients with creatinine clearance less than 30 mL/min, it is recommended that the dosing interval of tramadol hydrochloride tablets be increased to 12 hours, with a maximum daily dose of 200 mg. Since only 7% of an administered dose is removed by hemodialysis, dialysis patients can receive their regular dose on the day of dialysis.
Renal impairment
Impaired renal function results in a decreased rate and extent of excretion of tramadol and its active metabolite, M1. In patients with creatinine clearances of less than 30 mL/min, adjustment of the dosing regimen is recommended. The total amount of tramadol and M1 removed during a 4-hour dialysis period is less than 7% of the administered dose. [5]

Renal Impairment
Impaired renal function results in a decreased rate and extent of excretion of tramadol and its active metabolite, M1. Tramadol hydrochloride extended-release tablet or capsule has not been studied in patients with severe renal impairment (CLcr <30 mL/min). The limited availability of dose strengths and once-daily dosing of tramadol hydrochloride extended-release tablets or capsules do not permit the dosing flexibility required for safe use in patients with severe renal impairment (Child-Pugh Class C). Therefore, tramadol hydrochloride extended-release tablets or capsules should not be used in patients with severe renal impairment. [6], [7]

References: [5] Tramadol hydrochloride tablet. Prescribing information. Advagen Pharma Limited; 2023
[6] Tramadol hydrochloride tablet, extended-release. Prescribing information. Lupin Pharmaceuticals, Inc.; 2023
[7] Tramadol hydrochloride capsule, extended-release. Prescribing information. Trigen Laboratories, LLC; 2022
Literature Review

A search of the published medical literature revealed 1 study investigating the researchable question:

Is tramadol safe to use in patients with CKD?

Level of evidence

D - Case reports or unreliable data  Read more→



Please see Table 1 for your response.


 

Case of Rhabdomyolysis in a Patient Undergoing Hemodialysis: A Possible Association with Tramadol HCl

Design

Case report 

Case presentation

A 59-year-old male patient experienced rhabdomyolysis while undergoing hemodialysis, with possible association with tramadol. The patient presented with fatigue and generalized pain and had a history of multiple relapsing parathyroid carcinoma-related refractory hypercalcemia. The patient was initiated on low-calcium intermittent hemodialysis 3 days a week for refractory hypercalcemia. Over time, the patient required increased analgesia, which led to the use of fentanyl transdermal patch 25 mcg Q72H and tramadol HCl 100 mg BID. When the patient was admitted, tramadol HCl 100 mg Q2-3H was continued for 3 days, which led to observations of increased serum creatinine kinase levels. The serum creatinine kinase levels continued to increase the following day but eventually decreased on the second day. Unfortunately, the patient developed a pulmonary embolism and perished on the fourth day of treatment.

Study Author Conclusions

Narcotics result in direct cell toxicity and may increase the risk of rhabdomyolysis in drug users owing to staying in a stationary position after opioid injections. Our patient was also in a stationary position owing to his aggravating pain. Moreover, to a larger extent, tramadol HCl is excreted via kidneys. Therefore, in our case, decreased opioid clearance owing to renal failure may be considered an additional factor for rhabdomyolysis development.

References:
[1] Department of Internal Medicine, Division of Nephrology, Istanbul University-Cerrahpasa, Cerrahpasa School of Medicine, Istanbul, Turkey, Trabulus S, Ozbalak M, et al. Case of rhabdomyolysis in a patient undergoing hemodialysis: a possible association with tramadol hcl. Cerrahpasa Med J. 2019;43(1):34-36. doi:10.26650/cjm.2019.43.31