3.4 | Pain Medications Administered
The cohort in this study consisted of patients diagnosed with advanced
cancers with uncontrolled pain and were therefore prescribed opioids for
the management of pain. Figure 3 shows the oral morphine milligram
equivalent (MMeq) dose recorded as the study progressed from day 1 to
day 30 by groups.
During study progression from day 1 to day 30 all patients (n=25 of
Stage II) as a group recorded an increase in MMeq with a mean (SD) on
day 1 (baseline) of 152 (70.6) mg, on day 16 (end of intervention) of
153.6 (71.1) mg and on day 30 (end of follow-up) of 224.3 (124.2) mg,
respectively (Figure 4). Whereas MMeq administered in participants
diagnosed with breast or prostate cancers (n=8) with bone metastases
recorded significantly less changes as the study progressed. Mean (SD)
values of 61 (13.8) mg on day 1, 57.1 (12.9) mg on day 16 and 64.5
(18.1) mg on day 30 respectively.
The most frequently prescribed rescue opioids were oxycodone,
hydromorphone and morphine. As a group, patients diagnosed with bone
metastatic breast and prostate cancer reported less prescribed rescue
medications for the management of pain.
During the escalation phase of Stage II (Days 1 to 9) patients
administered a mean of 1.5 to 5.5 doses of NanaBisTMevery four hours unless asleep and was generally well tolerated. A
step-down dose-approach was adopted as per the treating clinician’s
discretion. During the treatment phase of Stage II (days 10 to 15)
patients administered a mean of 3 to 3.5 doses of
NanaBisTM every 4 hours unless asleep and again this
was generally reported as well tolerated. As per the protocol further
administration of the test cannabis-based medicine was discontinued from
day 16. However, 15 patients (60%) received compassionate use of
NanaBisTM on day 16 for an additional 24 hours.
The mean daily doses of NanaBisTM administered from
day 1 to day 15 is presented in
Figure 4.