title: 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.
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.
authors.affiliation: Department of Pediatrics, Emory University School of Medicine and Children's Healthcare of Atlanta, Atlanta, GA, USA. cdampie@emory.edu
authors.forename: Carlton D
authors.initials: CD
authors.lastname: Dampier
authors.forename: Wally R
authors.initials: WR
authors.lastname: Smith
authors.forename: Hae-Young
authors.initials: HY
authors.lastname: Kim
authors.forename: Carrie Greene
authors.initials: CG
authors.lastname: Wager
authors.forename: Margaret C
authors.initials: MC
authors.lastname: Bell
authors.forename: Caterina P
authors.initials: CP
authors.lastname: Minniti
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Keefer
authors.forename: Lewis
authors.initials: L
authors.lastname: Hsu
authors.forename: Lakshmanan
authors.initials: L
authors.lastname: Krishnamurti
authors.forename: A Kyle
authors.initials: AK
authors.lastname: Mack
authors.forename: Donna
authors.initials: D
authors.lastname: McClish
authors.forename: Sonja M
authors.initials: SM
authors.lastname: McKinlay
authors.forename: Scott T
authors.initials: ST
authors.lastname: Miller
authors.forename: Ifeyinwa
authors.initials: I
authors.lastname: Osunkwo
authors.forename: Phillip
authors.initials: P
authors.lastname: Seaman
authors.forename: Marilyn J
authors.initials: MJ
authors.lastname: Telen
authors.forename: Debra L
authors.initials: DL
authors.lastname: Weiner
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D016058:Analgesia, Patient-Controlled / Q000009:adverse effects / Q000379:methods*; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D002648:Child; D004305:Dose-Response Relationship, Drug; D057239:Early Termination of Clinical Trials; D005260:Female; D006450:Hemoglobin SC Disease / Q000503:physiopathology*; D006801:Humans; D004091:Hydromorphone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D007262:Infusions, Intravenous; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D009020:Morphine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D014652:Vascular Diseases / Q000209:etiology / Q000503:physiopathology; D055815:Young Adult
chemical_list: D000701:Analgesics, Opioid; D009020:Morphine; D004091:Hydromorphone