Contributions
Abstract: PB2372
Type: Publication Only
Background
Bone marrow aspiration and biopsy (BMAB) is a painful procedure, and the commonly adopted local infiltration anesthesia (LIA) with lidocaine is unable to relieve the pain during the most uncomfortable phases, or the anticipatory anxiety related to pain recalling thereafter. As there are no formal guidelines for adding a sedoanalgesic premedication before beginning the BMAB, many combinations have been adopted by several authors.
Aims
Our randomized and patient blinded trial aimed to evaluate, as primary end point, the efficacy and safety of opioid and benzodiazepine agent combination plus LIA in patients who underwent BMAB for hematological malignancies. Two secondary end points were: 1) to define if patients who already underwent to BMAB without LIA prefer sedoanalgesia; 2) to demonstrate if sedoanalgesia can influence the quality of the biological specimen harvested.
Methods
Patients were randomly assigned into two arms for receiving either placebo plus LIA (standard group, 48,6%) or oral fentanyl citrate 200 mcg plus oral midazolam 5 mg in addition to LIA (combo-group, 51,4%) during BMAB. Pre-procedural anxiety and procedural pain were assessed according to the Numered Rating Scale (NRS: 0-10), dividing the time of the procedure into five intervals (T0, T1, T2a, T2b, and T3) and evaluating discomfort grade during each moment of procedure in both groups. Cognitive function was measured before and 30 minutes after the procedure. Possible side effects were recorded, as well as the adequacy of tissue samples harvested. A telephone interview was performed 24 hours later. A total number of one-hundred-sixteen (n =116) were enrolled in the study. Nine (n = 9) patients did not meet inclusion criteria and were excluded. Fifty-two (n = 52) patients were randomized and assigned to standard group and fifty-five (n = 55) to combo group (Figure 1).
Results
At T2b and T3 (corresponding to the biopsy time and time after the biopsy, respectively) there was a significantly lower (p< 0.05) perception of pain in the patients who received sedoanalgesia (combo-group) compared to those who did not (standard group). Moreover, 100 % of the patients in combo group who had previously undergone this procedure without premedication reported that they would prefer sedoanalgesia for the subsequent procedures, thus confirming the effectiveness of this combination also in relieving anticipatory anxiety. Finally, the histological specimen was found to be high in quality, as defined by standards.
Conclusion
Administration of oral analgesia and anxiolysis is a safe and feasible option to be used in outpatient setting; sedoanalgesia is very effective in reducing pain during the biopsy and it diminishes the anticipatory anxiety related to a painful procedure. Patients should have the possibility to choose between local anesthesia alone or sedoanalgesia plus local anesthesia.
Session topic: 36. Quality of life, palliative care, ethics and health economics
Keyword(s): Pain, Supportive care, Bone Marrow, Bone marrow biopsy
Abstract: PB2372
Type: Publication Only
Background
Bone marrow aspiration and biopsy (BMAB) is a painful procedure, and the commonly adopted local infiltration anesthesia (LIA) with lidocaine is unable to relieve the pain during the most uncomfortable phases, or the anticipatory anxiety related to pain recalling thereafter. As there are no formal guidelines for adding a sedoanalgesic premedication before beginning the BMAB, many combinations have been adopted by several authors.
Aims
Our randomized and patient blinded trial aimed to evaluate, as primary end point, the efficacy and safety of opioid and benzodiazepine agent combination plus LIA in patients who underwent BMAB for hematological malignancies. Two secondary end points were: 1) to define if patients who already underwent to BMAB without LIA prefer sedoanalgesia; 2) to demonstrate if sedoanalgesia can influence the quality of the biological specimen harvested.
Methods
Patients were randomly assigned into two arms for receiving either placebo plus LIA (standard group, 48,6%) or oral fentanyl citrate 200 mcg plus oral midazolam 5 mg in addition to LIA (combo-group, 51,4%) during BMAB. Pre-procedural anxiety and procedural pain were assessed according to the Numered Rating Scale (NRS: 0-10), dividing the time of the procedure into five intervals (T0, T1, T2a, T2b, and T3) and evaluating discomfort grade during each moment of procedure in both groups. Cognitive function was measured before and 30 minutes after the procedure. Possible side effects were recorded, as well as the adequacy of tissue samples harvested. A telephone interview was performed 24 hours later. A total number of one-hundred-sixteen (n =116) were enrolled in the study. Nine (n = 9) patients did not meet inclusion criteria and were excluded. Fifty-two (n = 52) patients were randomized and assigned to standard group and fifty-five (n = 55) to combo group (Figure 1).
Results
At T2b and T3 (corresponding to the biopsy time and time after the biopsy, respectively) there was a significantly lower (p< 0.05) perception of pain in the patients who received sedoanalgesia (combo-group) compared to those who did not (standard group). Moreover, 100 % of the patients in combo group who had previously undergone this procedure without premedication reported that they would prefer sedoanalgesia for the subsequent procedures, thus confirming the effectiveness of this combination also in relieving anticipatory anxiety. Finally, the histological specimen was found to be high in quality, as defined by standards.
Conclusion
Administration of oral analgesia and anxiolysis is a safe and feasible option to be used in outpatient setting; sedoanalgesia is very effective in reducing pain during the biopsy and it diminishes the anticipatory anxiety related to a painful procedure. Patients should have the possibility to choose between local anesthesia alone or sedoanalgesia plus local anesthesia.
Session topic: 36. Quality of life, palliative care, ethics and health economics
Keyword(s): Pain, Supportive care, Bone Marrow, Bone marrow biopsy