Opioid patient controlled analgesia use during the initial experience with the IMPROVE PCA trial: A phase III analgesic trial for hospitalized sickle cell patients with painful episodes

• Type of Material: Article
• Authors: Carlton Dampier, Emory University; Wally R. Smith, Virginia Commonwealth University; Hae-Young Kim, New England Research Institutes; Carrie Greene Wager, New England Research Institutes; Margaret C. Bell, New England Research Institutes; Caterina P Minniti, National Institutes of Health; Jeffrey Keefer, Johns Hopkins University School of Medicine; Lewis Hsu, Children's National Medical Center; Lakshmanan Krishnamurti, Emory University; A. Kyle Mack, Children's Memorial Hospital; Donna McClish, Virginia Commonwealth University; Sonja M. McKinlay, New England Research Institutes; Scott T. Miller, New England Research Institutes; Ifeyinwa Osunkwo, Emory University; Phillip Seaman, Johns Hopkins University School of Medicine; Marilyn J. Telen, Duke University Medical Center; Debra L. Weiner, Children's Hospital Boston
• Language: English
• Date: 2011-12-01
• Publisher: Wiley: 12 months
• Publication Version: Final Published Version
• Copyright Statement: © Wiley-Liss, Inc.
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1002/ajh.22176
• Title of Journal or Parent Work: American Journal of Hematology
• ISSN: 0361-8609
• Volume: 86
• Issue: 12
• Start Page: E70
• End Page: E73
• Grant/Funding Information: This publication was made possible by Grant Number U10HL083721 from the National Heart, Lung, and Blood Institute, National Institutes of Health.
• Keywords: clinical trial; opioids; PCA; sickle cell disease
• Research Categories: Health Sciences, General; Health Sciences, Medicine and Surgery

Abstract

Opioid analgesics administered by patient-controlled analgesia (PCA)are frequently used for pain relief in children and adults with sickle cell disease (SCD) hospitalized for persistent vaso-occlusive pain, but optimum opioid dosing is not known. To better define PCA dosing recommendations,a multi-center phase III clinical trial was conducted comparing two alternative opioid PCA dosing strategies (HDLI—higher demand dose with low constant infusion or LDHI—lower demand dose and higher constant infusion) in 38 subjects who completed randomization prior to trial closure. Total opioid utilization (morphine equivalents,mg/kg) in 22 adults was 11.6 ± 2.6 and 4.7 ± 0.9 in the HDLI andin the LDHI arms, respectively, and in 12 children it was 3.7 ± 1.0 and 5.8 ± 2.2, respectively. Opioid-related symptoms were mild and similar in both PCA arms (mean daily opioid symptom intensity score: HDLI0.9 ± 0.1, LDHI 0.9 ± 0.2). The slow enrollment and early study termination limited conclusions regarding superiority of either treatment regimen. This study adds to our understanding of opioid PCA usage in SCD. Future clinical trial protocol designs for opioid PCA may need to consider potential differences between adults and children in PCA usage.