Combined Oral Fentanyl Citrate and Midazolam as Premedication for Bone Marrow Aspiration and Biopsy in Patients with Hematological Malignancies: A Randomized, Controlled and Patient-Blinded Clinical Trial

Abstract

Bone marrow aspiration and biopsy (BMAB) is a painful procedure, and the routinely used local infiltration anesthesia (LIA) with lidocaine is unable to provide pain relief during the most uncomfortable phases. The primary endpoint of the present randomized, patient-blinded trial was to evaluate the efficacy of an opioid and benzodiazepine combination plus LIA (sedoanalgesia) in patients undergoing BMAB for hematological malignancies. The secondary endpoint was the safety of the procedure in an outpatient setting. Ancillary assessments were anticipatory anxiety related to pain recall in the event of re-biopsy, and adequacy of bone tissue harvested. Patients were randomly assigned to one of 2 arms to receive either sedoanalgesic placebo plus LIA (standard group) or oral fentanyl citrate 200 µg plus oral midazolam 5 mg plus LIA (combo group) during BMAB. Pre-procedural anxiety and procedural pain were assessed according to the Numerical Rating Scale (NRS: 0-10), dividing the time of the procedure into five intervals (T0, T1, T2a, T2b and T3) and evaluating the degree of discomfort at each time (T) in both groups. One hundred and sixteen patients were eligible for the study. At T2b (time of biopsy) and T3 (time after biopsy), a significantly lower perception of pain was registered in the combo group. Moreover, there were no significant sedoanalgesia-related side-effects. Finally, histological specimens were higher in quality in the combo

Safety and feasibility of sutureless pars-plana vitrectomy in sub-Tenon anesthesia (SAFE-VISA): a prospective study

“…Compared to our study, differences in the applied anesthetics and the standard application of 5.0 ml midazolam 5 mg/ml, a benzodiazepine, could explain the lower reported pain perception. In other settings, a sedoanalgesia combination showed lower levels of perceived pain than analgesia alone [ 22 ]. We decided not to use systemic anxiolytic benzodiazepines to reduce risk of cardiovascular depression, avoid obligatory involvement of anesthesiologists and postoperative monitoring, thus reducing workload, and accelerating the workflow up to, and after the surgery itself.…”

“…Regarding pain perceived during surgery, all authors concluded, that sub-Tenon anesthesia is a valid option, similarly effective as retrobulbar anesthesia, and more effective than peribulbar anesthesia [ 4 , 15 , 17 , 22 ]. Gill et al added that a two-quadrant sub-Tenon injection provided significantly better perioperative anesthesia for vitrectomy compared with a standard single-quadrant technique using the same mixture [ 18 ].…”