Sara Zarnegar-Lumley1,2, Katharine R Lange3,4, Melissa D Mathias3,5, Miho Nakajima-Hatano3,6, Katharine M Offer3,7, Ugochi O Ogu3,8, Michael V Ortiz3, Kay See Tan9, Michael Kellick10, Shakeel Modak3, Stephen S Roberts3, Ellen M Basu3, R Scott Dingeman3,11,12. 1. Departments of Pediatrics, sara.zarnegar@vumc.org. 2. Division of Hematology/Oncology, Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee. 3. Departments of Pediatrics. 4. Children's Minnesota Hematology Oncology, Minneapolis, Minnesotta. 5. Regeneron Pharmaceuticals, Tarrytown, New York. 6. National Cancer Center, Tokyo, Japan. 7. Children's Cancer Institute, Joseph M. Sanzari Children's Hospital, Hackensack University Medical Center, Hackensack, New Jersey. 8. Division of Hematology, Department of Oncology, Montefiore Medical Center, Bronx, New York; and. 9. Epidemiology and Biostatistics. 10. Pharmacy, and. 11. Anesthesiology and Critical Care Medicine, Memorial Sloan Kettering Cancer Center, New York, New York. 12. Division of Pediatric Anesthesiology, Department of Anesthesiology and Critical Care Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland.
Abstract
BACKGROUND:Pediatric patients with cancer undergo repeated painful procedures, including bone marrow aspirations and biopsies (BMABs). Optimal management of procedure-related pain can reduce discomfort, anxiety, and distress. METHODS:Children with neuroblastoma were randomly assigned to 1 of 2 arms on a prospective, single-blind, crossover trial conducted at Memorial SloanKettering Cancer Center from October 2016 to January 2018 (www.clinicaltrials.gov, identifier NCT02924324). Participants underwent 2 sequential BMABs: one with general anesthesia (GA) alone, the other with GA plus local anesthesia (LA) (GA + LA). The objective was to assess procedure-related pain and its interference with quality of life (QoL) with GA versus GA + LA. Primary outcome was percentage of participants requiring postprocedural opioids. Secondary outcomes were total opioid and nonopioid analgesics, pain scores, time to first analgesic, QoL, and toxicity. Management of postprocedural pain was standardized. RESULTS: Of 56 participants randomly assigned (3-16.5 years old), 46 completed both procedures. There was no significant difference in percentage of participants requiring opioids with GA versus GA + LA (24% vs 20%, P = .5). Pain scores in the recovery room were significantly lower for GA + LA versus GA (median [IQR]: 0 [0-2] vs 2 [0-4], P = .002). There were no statistically significant differences in total opioid or nonopioid analgesic, 6- and 24-hour pain scores, median time to first analgesic, or pain interference. No adverse events occurred. CONCLUSIONS:LA was associated with significant improvement in pain scores in the immediate recovery period. LA did not reduce postprocedural opioid use, nor did it improve QoL for patients undergoing BMAB with GA.
RCT Entities:
BACKGROUND: Pediatric patients with cancer undergo repeated painful procedures, including bone marrow aspirations and biopsies (BMABs). Optimal management of procedure-related pain can reduce discomfort, anxiety, and distress. METHODS:Children with neuroblastoma were randomly assigned to 1 of 2 arms on a prospective, single-blind, crossover trial conducted at Memorial Sloan Kettering Cancer Center from October 2016 to January 2018 (www.clinicaltrials.gov, identifier NCT02924324). Participants underwent 2 sequential BMABs: one with general anesthesia (GA) alone, the other with GA plus local anesthesia (LA) (GA + LA). The objective was to assess procedure-related pain and its interference with quality of life (QoL) with GA versus GA + LA. Primary outcome was percentage of participants requiring postprocedural opioids. Secondary outcomes were total opioid and nonopioid analgesics, pain scores, time to first analgesic, QoL, and toxicity. Management of postprocedural pain was standardized. RESULTS: Of 56 participants randomly assigned (3-16.5 years old), 46 completed both procedures. There was no significant difference in percentage of participants requiring opioids with GA versus GA + LA (24% vs 20%, P = .5). Pain scores in the recovery room were significantly lower for GA + LA versus GA (median [IQR]: 0 [0-2] vs 2 [0-4], P = .002). There were no statistically significant differences in total opioid or nonopioid analgesic, 6- and 24-hour pain scores, median time to first analgesic, or pain interference. No adverse events occurred. CONCLUSIONS: LA was associated with significant improvement in pain scores in the immediate recovery period. LA did not reduce postprocedural opioid use, nor did it improve QoL for patients undergoing BMAB with GA.
Authors: Chiara Po'; Franca Benini; Laura Sainati; Anna C Frigo; Simone Cesaro; Maria I Farina; Caterina Agosto Journal: Ital J Pediatr Date: 2011-06-10 Impact factor: 2.638
Authors: Mark T Holdsworth; Dennis W Raisch; Stuart S Winter; Jami D Frost; Michele A Moro; Nivine H Doran; Joyce Phillips; Jan M Pankey; Prasad Mathew Journal: Ann Pharmacother Date: 2003-01 Impact factor: 3.154