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.

Journal Article (Clinical Trial, Phase III;Letter;Multicenter Study)

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.

Full Text

Duke Authors

Cited Authors

  • Dampier, CD; Smith, WR; Kim, H-Y; Wager, CG; Bell, MC; Minniti, CP; Keefer, J; Hsu, L; Krishnamurti, L; Mack, AK; McClish, D; McKinlay, SM; Miller, ST; Osunkwo, I; Seaman, P; Telen, MJ; Weiner, DL; Investigators of the Sickle Cell Disease Clinical Research Network (SCDCRN),

Published Date

  • December 2011

Published In

Volume / Issue

  • 86 / 12

Start / End Page

  • E70 - E73

PubMed ID

  • 21953763

Pubmed Central ID

  • PMC4573530

Electronic International Standard Serial Number (EISSN)

  • 1096-8652

Digital Object Identifier (DOI)

  • 10.1002/ajh.22176


  • eng

Conference Location

  • United States