Page 86 - Journal of Special Operations Medicine - Summer 2014
P. 86

The informed consent document explained that pa-   line on which the patients were to mark their cur-
          tients would be randomly assigned to receive an intra-  rent pain at each time interval while in the ED up to
          articular knee injection of either morphine, lidocaine,   the 2-hour point. At the 2-hour point, the patients
          or a combination of morphine and lidocaine to treat   were discharged with a written pain survey to take
          their acute pain. They were notified that they would be   home and mail back to the investigators in a provided
          asked to rate their pain at various time intervals and   stamped, preaddressed envelope. The home pain sur-
          mail back a pain survey after discharge from the ED.   vey asked patients to report their current pain at 6
          Furthermore, patients were warned of risks involving   hours after injection on a 100mm VAS and again at
          local discomfort, infection, reactive synovitis, iatrogenic   24 hours on a new 100mm VAS. At 24 hours, the
          injury, damage to cells composing the cartilage, and al-  patients also answered questions on the home pain
          lergic reactions. Patients were then advised to not drive   survey as to the estimated amount of time they ap-
          or operate dangerous machinery or perform dangerous   plied ice to the knee, how many ice applications were
          activities within 8 hours of the treatment. Finally, they   made, and the amount of oxycodone 5mg/ acetamin-
          were assured that if they did not want to participate,   ophen 325mg and ibuprofen 800mg they consumed
          there were other treatment modalities available such as   in the previous 24 hours. The home pain survey also
          oral analgesia and ice.                            solicited any patient-perceived negative side effects of
                                                             the medication.
          After consent, patients were randomized to one of the
          following three treatment arms (Figure 1):         The VAS is a validated method of assessing clinically
                                                             important changes in pain severity.  Measurements of
                                                                                            10
          1.  Morphine only: 5mL of morphine (5mg) and 5mL of   where the patient placed a mark for their pain on the
             saline (10mL total solution)                    VAS were made in millimeters and measured by a third
          2.  Lidocaine only: 5mL of 2% lidocaine (100mg) and   party emergency physician not otherwise affiliated with
             5mL of saline (10mL total solution)             the study. For ice application, patients were instructed
          3.  Lidocaine and morphine: 5mL of morphine (5mg)   to use an over-the-counter ice pack or home-made ice
             and 5mL of 2% lidocaine (100mg) (10mL total     pack using a quart-sized bag.
             solution)
                                                             Results
          Figure 1  Participant Selection and Flow.
                                                             The original design was to have 45 patients in each of
                                                             the 3 arms. Once 30 patients were in each arm, an in-
                                                             terim power analysis was planned to adjust the target
                                                             patient sample size  as appropriate.  However, due to
                                                             the nature of convenience enrollment in this unfunded
                                                             study, the number of patients enrolled was eight.

                                                             Due to low patient enrollment numbers and a lack of
                                                             statistical power, analyses consisted of averaging VAS
                                                             pain measurements, oral analgesia usage, and ice usage.
                                                             The raw data (Table 2) showed a possible positive trend
                                                             toward a greater reduction in pain on the VAS for injec-
                                                             tions containing morphine versus lidocaine-only injec-
                                                             tions (Figure 3). The average reduction in patient-rated
                                                             pain by millimeters on VAS at each time interval for the
          The study medication was then injected into the knee   lidocaine group was 30 minutes, 22mm; 60 minutes,
          by an emergency medicine resident or staff emergency   34mm; 90 minutes, 34.5mm; 2 hours, 25mm; 6 hours,
          physician, both familiar with acute knee injuries. The   21mm; and 24 hours, 20mm. The average reduction in
          injecting provider was provided a handout on aspiration   patient-rated pain by millimeters on VAS at each time
          and injection techniques and instructed to conform to   interval for the lidocaine and morphine group was 30
          the handout (Figure 2).                            minutes, 33mm; 60 minutes, 44mm; 90 minutes, 45mm;
                                                             2 hours, 46mm; 6 hours, 29mm; and 24 hours, 27mm.
          The patients self-reported their level of knee pain via   The average reduction in patient-rated pain by milli-
          a standard 100mm VAS just before the injection and   meters on VAS at each time interval for the morphine
          30 minutes, 60 minutes, 90 minutes, 2 hours, 6 hours,   group was 30 minutes, 35mm; 60 minutes, 40mm; 90
          and 24 hours postinjection. The initial VAS data were   minutes, 44mm; 2 hours, 48mm; 6 hours, 46mm; and
          collected on a written pain survey with a new VAS   24 hours, 60mm.



          76                                   Journal of Special Operations Medicine  Volume 14, Edition 2/Summer 2014
   81   82   83   84   85   86   87   88   89   90   91