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Cerchione C, Martinelli G, Picardi M, et al. 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. J Clin Med. 2020;9(2)doi: 10.3390/jcm9020395.
Cerchione, C., Martinelli, G., Picardi, M., Pugliese, N., Nappi, D., Casoria, A., Gravetti, A., Cangini, D., Giannini, M. B., Ronconi, S., Simonetti, G., Ghelli Luserna Di Rorà, A., De Giorgi, U., Altini, M., Bravaccini, S., Santoriello, I., Minucci, C., Pane, F., & Martinelli, V. (2020). 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. Journal of clinical medicine, 9(2), . https://doi.org/10.3390/jcm9020395
Cerchione, Claudio, et al. "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." Journal of clinical medicine vol. 9,2 (2020). doi: https://doi.org/10.3390/jcm9020395
Cerchione C, Martinelli G, Picardi M, Pugliese N, Nappi D, Casoria A, Gravetti A, Cangini D, Giannini MB, Ronconi S, Simonetti G, Ghelli Luserna Di Rorà A, De Giorgi U, Altini M, Bravaccini S, Santoriello I, Minucci C, Pane F, Martinelli V. 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. J Clin Med. 2020 Feb 01;9(2). doi: 10.3390/jcm9020395. PMID: 32024148; PMCID: PMC7074337.
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J Clin Med. 2020 Feb 01;9(2). doi: 10.3390/jcm9020395.

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.

Journal of clinical medicine

Claudio Cerchione, Giovanni Martinelli, Marco Picardi, Novella Pugliese, Davide Nappi, Aniello Casoria, Angela Gravetti, Delia Cangini, Maria Benedetta Giannini, Sonia Ronconi, Giorgia Simonetti, Andrea Ghelli Luserna Di Rorà, Ugo De Giorgi, Mattia Altini, Sara Bravaccini, Ilaria Santoriello, Cristiano Minucci, Fabrizio Pane, Vincenzo Martinelli

Affiliations

  1. Hematology Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, 47014 Meldola, Italy.
  2. Hematology, Department of Clinical Medicine and Surgery, AOU Federico II, 80131 Naples, Italy.
  3. Hematology Unit, Azienda Ospedaliera di Rilievo Nazionale (AORN) Antonio Cardarelli, 80131 Naples, Italy.
  4. Biosciences Laboratory, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, 47014 Meldola, Italy.
  5. Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, 47014 Meldola, Italy.
  6. Healthcare Administration, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, 47014 Meldola, Italy.
  7. Department of Anesthesiology, Federico II University, 80131 Naples, Italy.

PMID: 32024148 PMCID: PMC7074337 DOI: 10.3390/jcm9020395

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 group. Sedoanalgesia was highly effective in reducing pain during biopsy, diminished anticipatory anxiety in patients undergoing re-biopsy and led to fewer non-diagnostic specimens being harvested.

Keywords: analgesia; anxiolysis; bone marrow aspiration and biopsy; fentanyl citrate; pain

Conflict of interest statement

The authors declare no conflict of interest.

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