Procedural sedation and analgesia for percutaneous trans-hepatic biliary drainage: Randomized clinical trial for comparison of two different concepts

Abstract

Procedural sedation and analgesia (PSA) is important during painful dilatation and stenting in patients undergoing percutaneous trans-hepatic biliary drainage (PTBD). A prospective, nonblinded randomized clinical trial was performed comparing different analgesic regimens with regard to the patient's comfort. Patients were randomly assigned to two treatment groups in a parallel study, receiving either remifentanil or combined midazolam, piritramide, and S-ketamine. The primary study endpoint was pain intensity before, during, and after the intervention using the numerical rating scale (0, no pain; 10, maximum pain). The secondary study endpoint was the satisfaction of the interventional radiologist. Fifty patients underwent PTBD of whom 19 (38.0%) underwent additional stenting. During intervention, the two groups did not differ significantly. After the intervention, the need for auxiliary opioids was higher (12.5% vs 7.7%; p = 0.571) and nausea/vomiting was more frequently observed (33.4% vs 3.8%; p = 0.007) in patients with remifentanil than in patients with PSA. Overall, 45 patients (90.0%) needed additional administration of non-opioid analgesics during postinterventional observation. Remifentanil and combined midazolam, piritramide, and S-ketamine obtained adequate analgesic effects during PTBD. After the intervention, medications with antiemetics and long-acting analgesics were more frequently administered in patients treated with remifentanil (EudraCT No. 2006-003285-34; institutional funding).

Keywords: S-ketamine; analgesia; biliary tract; cholestasis; interventional radiology; midazolam; piritramide; procedural sedation; remifentanil.

Conflict of interest statement

Conflict of interest: This investigation served Katrin Böker as descriptive research in a master thesis on at the UMIT – Private University for Health Sciences, Medical Informatics and Technology, Hall in Tyrol, Austria. The abstract was presented at the Euroanaesthesia 2015, The European Anaesthesiology Congress, Berlin, Germany, May 30 – June 2, 2015. Corresponding author Dr Franz J. Wiedermann, serve as Section Editor for Open Medicine, but this fact hasnt affected the peer-review process. The authors state no conflict of otherwise interest, also financial.

© 2020 Alex Zanvettor et al., published by De Gruyter.

Figures

Figure 1

Flowchart of a parallel randomized trial of two groups, modified from the Consolidated Standards of Reporting Trials 2010.

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