TIME1: A 2 X 2 Factorial Trial to Assess Whether Non-Steroidal Anti-Inflammatory Analgesics and Small-Bore Chest Tubes Are Less Painful Than Opiate Analgesics and Large-Bore Chest Tubes in Pleurodesis for Malignant Pleural Effusion.
Patients with metastatic cancer often have fluid collecting around the lung as a result of
cancer cells spreading to the membranes adjacent to the lung (malignant pleural effusion).
The standard way of treating this condition, which may cause unpleasant symptoms such as
breathlessness and cough, is to drain the fluid off and then seal the cavity, using a drug
(talc) given into the chest drain. Talc causes inflammation in the lining of the lung and
chest wall, sticking the two surfaces together and preventing fluid from recurring. This
procedure is often very painful; the pain may be partly related to the size of the chest
tube used and the type of analgesia taken by the patient during the procedure. Reducing the
amount of pain associated with this procedure would be a substantial benefit for patients
undergoing this procedure.
This trial is looking at which of two different drug regimens is more effective in
preventing pleurodesis pain, and whether the size of chest tube influences pain. It will
also address whether either of these influences success rate of pleurodesis.
We hope to learn whether the size of chest drain or the type of pain medication given
(ibuprofen or morphine) influences the amount of pain felt after the pleurodesis procedure.
We hope to find the best way of preventing pain during this procedure.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Supportive Care
An average pain score over 72 hours post pleurodesis for malignant pleural effusion
RJO Davies, Dr.
Oxford Pleural Unit, Churchill Hospital, Oxford, England
United States: Institutional Review Board
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