We found a match
Your institution may have rights to this item. Sign in to continue.
- Title
Effect of Opioids vs NSAIDs and Larger vs Smaller Chest Tube Size on Pain Control and Pleurodesis Efficacy Among Patients With Malignant Pleural Effusion: The TIME1 Randomized Clinical Trial.
- Authors
Rahman, Najib M.; Pepperell, Justin; Rehal, Sunita; Saba, Tarek; Tang, Augustine; Ali, Nabeel; West, Alex; Hettiarachchi, Gihan; Mukherjee, Dipak; Samuel, Johnson; Bentley, Andrew; Dowson, Lee; Miles, Jonathan; Ryan, C. Frank; Yoneda, Ken Y.; Chauhan, Anoop; Corcoran, John P.; Psallidas, loannis; Wrightson, John M.; Hallifax, Rob
- Abstract
<bold>Importance: </bold>For treatment of malignant pleural effusion, nonsteroidal anti-inflammatory drugs (NSAIDs) are avoided because they may reduce pleurodesis efficacy. Smaller chest tubes may be less painful than larger tubes, but efficacy in pleurodesis has not been proven.<bold>Objective: </bold>To assess the effect of chest tube size and analgesia (NSAIDs vs opiates) on pain and clinical efficacy related to pleurodesis in patients with malignant pleural effusion.<bold>Design, Setting, and Participants: </bold>A 2×2 factorial phase 3 randomized clinical trial among 320 patients requiring pleurodesis in 16 UK hospitals from 2007 to 2013.<bold>Interventions: </bold>Patients undergoing thoracoscopy (n = 206; clinical decision if biopsy was required) received a 24F chest tube and were randomized to receive opiates (n = 103) vs NSAIDs (n = 103), and those not undergoing thoracoscopy (n = 114) were randomized to 1 of 4 groups (24F chest tube and opioids [n = 28]; 24F chest tube and NSAIDs [n = 29]; 12F chest tube and opioids [n = 29]; or 12F chest tube and NSAIDs [n = 28]).<bold>Main Outcomes and Measures: </bold>Pain while chest tube was in place (0- to 100-mm visual analog scale [VAS] 4 times/d; superiority comparison) and pleurodesis efficacy at 3 months (failure defined as need for further pleural intervention; noninferiority comparison; margin, 15%).<bold>Results: </bold>Pain scores in the opiate group (n = 150) vs the NSAID group (n = 144) were not significantly different (mean VAS score, 23.8 mm vs 22.1 mm; adjusted difference, -1.5 mm; 95% CI, -5.0 to 2.0 mm; P = .40), but the NSAID group required more rescue analgesia (26.3% vs 38.1%; rate ratio, 2.1; 95% CI, 1.3-3.4; P = .003). Pleurodesis failure occurred in 30 patients (20%) in the opiate group and 33 (23%) in the NSAID group, meeting criteria for noninferiority (difference, -3%; 1-sided 95% CI, -10% to ∞; P = .004 for noninferiority). Pain scores were lower among patients in the 12F chest tube group (n = 54) vs the 24F group (n = 56) (mean VAS score, 22.0 mm vs 26.8 mm; adjusted difference, -6.0 mm; 95% CI, -11.7 to -0.2 mm; P = .04) and 12F chest tubes vs 24F chest tubes were associated with higher pleurodesis failure (30% vs 24%), failing to meet noninferiority criteria (difference, -6%; 1-sided 95% CI, -20% to ∞; P = .14 for noninferiority). Complications during chest tube insertion occurred more commonly with 12F tubes (14% vs 24%; odds ratio, 1.91; P = .20).<bold>Conclusions and Relevance: </bold>Use of NSAIDs vs opiates resulted in no significant difference in pain scores but was associated with more rescue medication. NSAID use resulted in noninferior rates of pleurodesis efficacy at 3 months. Placement of 12F chest tubes vs 24F chest tubes was associated with a statistically significant but clinically modest reduction in pain but failed to meet noninferiority criteria for pleurodesis efficacy.<bold>Trial Registration: </bold>isrctn.org Identifier: ISRCTN33288337.
- Subjects
THERAPEUTIC use of narcotics; PAIN management; THORACOSCOPY; ALGORITHMS; ANALGESIA; ANALGESICS; COMPARATIVE studies; CONFIDENCE intervals; RESEARCH methodology; MEDICAL cooperation; NARCOTICS; NONSTEROIDAL anti-inflammatory agents; PLEURA cancer; PLEURAL effusions; RESEARCH; RESEARCH funding; PRODUCT design; EVALUATION research; PAIN measurement; RANDOMIZED controlled trials; TREATMENT effectiveness; SALVAGE therapy; CHEST tubes; PLEURODESIS; DISEASE complications; EQUIPMENT &; supplies; CANCER treatment; THERAPEUTICS
- Publication
JAMA: Journal of the American Medical Association, 2015, Vol 314, Issue 24, p2641
- ISSN
0098-7484
- Publication type
journal article
- DOI
10.1001/jama.2015.16840