Oral Prednisolone Effect on Cancer WHO Stepladder Analgesia Protocol
Status:
Completed
Trial end date:
2020-03-01
Target enrollment:
Participant gender:
Summary
Introduction; World Health Organization (WHO) analgesic ladder; Step I recommends non-opioid
analgesics for mild pain. Step II specifies the use of weak opioids for moderate pain. Step
III comprises the use of strong opioids for severe pain. Cancer pain management using opioids
administered alone or in combination with adjuvant analgesics. Corticosteroids adjuvant use
for neuropathic and bone pain treatment. However, despite widespread use of corticosteroids,
scientific evidence about its efficacy in cancer pain management is limited. This protocol
aims to clarify pors and cons of interrupted steroid dosing in chronic cancer pain WHO
stepladder analgesia protocol. Methods; Prospective quizi-pre-post experimental study will be
conducted after IRB approval in the Mansoura oncology canter pain clinic-Faculty of medicine
Mansoura University Egypt. Verbal informed consent will be obtained from the respondents
(patients) for the interview. Furthermore, the data collected from each patient will be kept
confidential and used strictly only for the purpose of the study.
Patients will be allocated as single group and will take oral prednisolone (sulopride10 mg)
single dose every two days for 4 successive weeks then the next two weeks as washout period
(stop dosing gradually by taking 5 mgs for 3 successive dosing every 2nd day over a week,
then stop the oral steroid drug totally over the 2nd week of the washout period. The second
period of the study will start by taking the oral prednisolone (sulopride10 mg) every fourth
day for the next 4 weeks after which the patient will get another washout two weeks period
(stop dosing gradually 5 mgs for 3 successive dosing every 4th day then stop the drug
totally).A questionnaire-based interview using Brief Pain Inventory-Short Form (BPI-sf) (16)
based on VAS pain score as a rough tool for pain intensity Data collection: Primary Outcome:
global Pain intensity, assessed by a visual analogue scale (VAS) 0-10. Secondary outcomes
based on the Brief Pain Inventory short form (BPI-sf).