TIME‐1.

Trial name or title	The first therapeutic interventions in malignant effusion trial (TIME‐1)
Methods	2 x 2 randomised factorial trial to assess whether non‐steroidal analgesia and the use of small‐bore chest tubes will reduce pain during pleurodesis for MPE, compared to standard care
Participants	320 target recruitment (interim analysis after 120 participants) Inclusion: clinically confident diagnosis of MPE requiring pleurodesis; written informed consent; expected survival > 1 month Exclusion: age < 18; primary lymphoma or small cell lung carcinoma; pregnancy or lactation; history of gastro intestinal (GI) bleeding or untreated peptic ulceration; known sensitivity to non‐steroidal anti‐inflammatory drugs (NSAIDs) or opiates; hypercapnic ventilatory failure; intravenous drug use; severe renal or liver disease; bleeding diathesis; warfarin therapy which must be continued; current or recent corticosteroid therapy
Interventions	Participants will be randomised to one of the following arms: Large‐bore (24 F) chest drain and NSAID‐based analgesic regimen Small‐bore (12 F)chest drain and NSAID‐based analgesic regimen Large‐bore chest drain (24 F) and opiate‐based analgesic regimen Small‐bore chest drain (12 F) and opiate‐based analgesic regimen
Outcomes	Primary: pain score over 72 hours post pleurodesis Secondary: success of pleurodesis at 6 weeks and 3 months; presence of ipsilateral, chronic chest pain at 6 weeks and 3 months
Starting date	1 September 2006
Contact information	emma.hedley@ouh.nhs.uk
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