Two Step Versus the Standard Three Step Approach of the WHO Analgesic Ladder for Cancer Pain Relief. (TVT)

University of Edinburgh

Status

Completed

Conditions

Cancer

Pain

Treatments

Other: analgesic ladder

Study type

Interventional

Funder types

Other

Identifiers

NCT01493635

11/SS/0079

Details and patient eligibility

About

The World Health Organization analgesic ladder for cancer pain relief is an internationally used approach to managing cancer pain. Patients generally start on Step 1 of the ladder (paracetamol). As pain increases or is not well controlled on this, they progress to Step 2 which involves a stronger pain killer (weak opioid such as codeine). If pain is still not controlled they progress to Step 3 of the ladder which is a strong opioid (such as morphine). Work to date has suggested that Step 2 may be unnecessary and most patients usually require Step 3 analgesia. The TVT trial aims to examine the standard approach (Step 1-Step2-Step-3) versus a two step approach (Step 1-Step 3).

Enrollment

152 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

18 years of age and over.
Patient has a cancer diagnosis (based on radiological, histological, cytological, or operative evidence). Those with haematological malignancies are eligible.
Cancer related pain - which in the opinion of the clinician is caused by the presence of tumour or metastases.
Average pain score > 4, on a numerical rating scale from 0-10, requiring step 2 analgesia (weak opioid).
Patient is able to comply with trial procedures.

Exclusion criteria

Patients who have received radiotherapy in the previous 6 weeks or are planned to receive radiotherapy during the trial period where in either case, it is expected to affect pain during the trial period.
Pain due to surgery in the preceding 4 weeks.
Life expectancy less than two months (based on clinical impression).
Patients with psychotic disorders or cognitive impairment.
Patients who have received regular doses (scheduled doses - NOT as required dosing) of weak or strong opioids in the preceding two weeks.
Patients using immediate release opioids > 2 doses/24 hours, in the previous 24 hours.